Product Catalogue 2014 / 15. Solutions for Clinical Diagnostics

Transcription

1 Product Catalogue 214 / 15 Solutions for Clinical Diagnostics

2 Product Catalogue 214 / 15 Date of Release: February 214 RECIPE CHEMICALS + INSTRUMENTS GmbH Dessauerstraße Munich/Germany Phone: +49 / 89 / Fax: info@recipe.de

3 About RECIPE Who we are RECIPE was founded in Munich in 1982 and is one of the leading companies in HPLC and LC-MS/MS diagnostics today. RECIPEʼs success in more than 3 years has mainly been defined by the consistent implementation of a customer-oriented, stringent quality po li cy. Therefore quality is not a mere phrase for us. As supplier of diagnostic products we are rather aware of the special responsibility towards our cus tomers, and ultimately, the patients. With our premium quality products and our competent and fast service, we are a reli - able partner in laboratory diagnostics. All diagnostic products are developed and produced in our state-of-the-art manufacturing plant. The products of our instrumentʼs branch are being serviced in our inhouse workshop. All our company processes are controlled by a certified quality ma nagement system (ISO and ISO 91). Fur thermore we are regularly participating in na tio nal and European proficiency schemes to secure the quality assurance of our calibrator and control materials. Solutions for Clinical Diagnostics It is our goal to convince with quality, performance and innovation also in the future. In this product cata - logue you will find a series of new and innovative products, which are expanding our current portfolio especially in the sectors of therapeutic drug monitoring and automated LC-MS/MS analytics. We would like to thank all our customers with the new edition of this product catalogue and we are looking forward to a successful joint future in the coming years. Alfred Bauer, General Manager 3

4 New Products HPLC Complete Kits ClinRep Diagnostics ClinRep Therapeutic Drug Monitoring ClinTox Human Biomonitoring LC-MS/MS ClinMass Complete Kits ClinMass Optimisation Mixes and Internal Standards Quality Assurance ClinTest Solutions ClinCal Calibrators ClinChek Controls HPLC Instruments ClinLab HPLC Instruments Chromatography Software HPLC Accessories ClinRep Reagents for Chromatography ClinLab HPLC Accessories Index

5 New Products HPLC Complete Kits ClinRep Diagnostics Oxidative Stress ß-Carotene in Plasma / Serum ClinRep TDM Antiepileptic Drugs Antiepileptics in Serum / Plasma, advanced Antiepileptics in Serum / Plasma with UHPLC Levetiracetam (Keppra ) in Serum / Plasma Levetiracetam (Keppra ) in Serum / Plasma, Gilson ASPEC LC-MS/MS ClinMass Complete Kits Alcoholism Ethylglucuronide and Ethylsulfate in Urine, Plasma and Serum Immunosuppressants Immunosuppressants in Whole Blood, advanced On-Line Analysis Metabolic Disease Homocysteine in Plasma / Serum Homocysteine in Whole Blood (DBS) Vitamin Status Methylmalonic Acid in Serum / Plasma / Urine, advanced OH Vitamin D2 / D3 in Plasma and Serum On-Line Analysis ClinMass Optimisation Mixes and Internal Standards Optimisation Mix for 25-OH Vitamin D2 / D Optimisation Mix for 25-OH Vitamin D3 and C-3 Epimer Internal Standard for Ethylglucuronide (Plasma / Serum) Internal Standards for Homocysteine Internal Standard for Immunosuppressants Quality Assurance ClinTest Standard and Test Solutions Test Solution for ß-Carotene Standard Solution for Levetiracetam (Keppra ) ClinCal Calibrators Urine Calibrator for Occupational Medicine Urine Calibrator for Phenolic Compounds Serum Calibrator Set for Antiepileptics 2 (Level - 3) Serum Calibrator Set for Ethylglucuronide (Level - 3) Serum Calibrator Set for Homocysteine (Level - 3) Serum Calibrator for Levetiracetam (Keppra ) Whole Blood Calibrator Set (filter spots) for Homocysteine (Level - 3) Whole Blood Calibrator for Immunosuppressants (Level 7) ClinChek Controls CSF/Serum Control for CSF/Serum Quotients, Level I, II Serum Control for Ethylglucuronide, Level I, II Serum Control for Levetiracetam (Keppra ), Level I, II Serum Control for 25-OH Vitamin D2 / D3, Level I, II Whole Blood Control (filter spots) for Homocysteine, Level I, II ClinLab Instruments HPLC Thermostats HPLC Thermostat, Model HT

6 HPLC Complete Kits HPLC Complete Kits ClinRep Diagnostics ClinRep Therapeutic Drug Monitoring ClinTox Human Biomonitoring ClinRep HPLC Complete Kits are intended for diagnosis and therapeutic drug monitoring (TDM) in clinical, toxicological and forensic laboratories. ClinTox HPLC Complete Kits are designed for human biomonitoring (HBM) in laboratories for occupational medicine. Our test kits can be used with any conventional HPLC system. A complete kit contains all components required for analysis, such as buffers, rea - gents for sample preparation, standards, and a matrix calibrator. Start accessories (such as guard-, SPE-, and analytical columns), matrix controls, and further accessories are additionally available. 9

7 Diagnostics HPLC Complete Kits ClinRep Diagnostics for clinical, toxicological and forensic analysis Alcoholism, Drug Abuse CDT in Serum Manual sample preparation On-Line Analysis On-Line Analysis, automated TOX.I.S. TM (On-Line Analysis) Basic Drugs in Urine Pharmaceuticals in Plasma Pharmaceuticals in Urine Biogenic Amines Catecholamines in Plasma Catecholamines in Urine Manual sample preparation with Gilson ASPEC XL with HTA, Model HT4E On-Line Analysis Metanephrines in Urine Manual sample preparation with Gilson ASPEC XL with HTA, Model HT4E Serotonin in Plasma Serotonin in Urine VMA, HVA, 5-HIAA in Urine Manual sample preparation with Gilson ASPEC XL with HTA, Model HT4E Diabetes, Hemoglobins Hemoglobin A1c (HbA1c) in Whole Blood with Diamat TM Hemoglobin A1c (HbA1c) in Whole Blood with Variant TM Hemoglobin Variants and β-thalassemia Screening in Whole Blood Metabolic Diseases 5-Aminolevulinic Acid / Porphobilinogen in Urine Homocysteine in Plasma Hydroxyproline in Urine Porphyrins Differentiated in Urine Total Porphyrins in Urine Oxidative Stress β-carotene in Plasma / Serum Coenzyme Q1 in Whole Blood / Plasma / Serum Malondialdehyde in Plasma / Serum Vitamin C in Plasma Vitamin Status Vitamin A and E in Plasma Vitamin B1 in Whole Blood Vitamin B2 in Whole Blood Vitamin B6 in Plasma / Whole Blood Vitamin B1, B2, B6 (Combikit) OH Vitamin D2 / D3 in Plasma and Serum with HPLC with UHPLC

8 CDT (carbohydrate deficient transferrin) is the most specific parameter for chronic alcohol abuse. The ClinRep HPLC Complete Kit for CDT provides a unique chromatographical resolution compared to other commercially available test kits. The analytical method correlates with the candidate reference method of the IFCC-CDT-WG* and ensures a reliable separation of all relevant transferrin isoforms (a-, mono-, di-,, hexasialotransferrin). This applies in particular for disialotransferrin, the most important CDT isoform. Alternatively to this method with manual sample preparation, ClinRep Complete Kits for online analysis and automated on-line analysis via 96- well plates are available (see pages 14-17). * Working group of the IFCC for the international standardisation of CDT measurement. Alcoholism, Drug Abuse CDT in Serum Test Data LLOD:.1 %* LLOQ:.3 %* Intraassay precision: 4.2 % Interassay precision: 4.3 % * depending on the amount of total transferrin and on detector sensitivity HPLC Parameters Pump: ternary gradient pump, flow rates: 1.2, 2. ml/min Injection volume: 4-5 μl Injection interval: 2 min UV/VIS-Detector: 46 nm HPLC-Thermostat: 4 C Sample Preparation Stabilisation/Precipitation: 15 μl serum 1. incubate (3 min, 4 C) 3 μl Stabilising Reagent S 2. centrifuge 1 μl mixture of Precipitants P1+P2 Native sample, normal range Disialotransferrin: 6.22 min, Trisialotransferrin: 6.85 min, Tetrasialotransferrin: 7.73 min, Pentasialotransferrin: 8.75 min, Hexasialotransferrin: 9.65 min Native sample, pathological range Asialotransferrin: 4.25 min, Disialotransferrin: 5.98 min, Trisialotransferrin: 6.71 min, Tetrasialotransferrin: 7.69 min, Pentasialotransferrin: 8.66 min, Hexasialotransferrin: 9.57 min 21 ClinRep Complete Kit for CDT in Serum for 1 assays Kit Components (order no. 21): 217 Mobile Phase A 3 x 217 (3 x 2 ml) 218 Mobile Phase B 2 ml 219 Mobile Phase C 2 ml 212 Sample Preparation Vials 2 x 212 (2 x 1 pcs.) 2121 Stabilising Reagent S 3 ml 2122 Precipitant P1 1 ml 2123 Precipitant P2 2 ml 2124 Diluting Solution D 1 ml Manual Quick Reference Diagnostics Dilution: 1 μl supernatant HPLC Analysis: 1. ml Diluting Solution D Optional Components: 2114 Test Solution 15 ml Start Accessories: 213 Analytical Column with test chromatogram 2132 Cartridge incl. 1 precolumn Inject 4-5 μl Refill Service: 2131 Analytical Column with test chromatogram (original column needs to be returned) Unique chromatographical resolution Accessories: 2133 Precolumns 5 pcs. FK535 Sample loop, PEEK, 5 μl FK581 PEEK tubing (connection of prefilter and column) FW3 Fixed-Wavelength-VIS-Detector (46 nm), complete RC22 Sodium-Hypochlorite-Solution (5 %) 12 ml Quantification of all relevant transferrin isoforms (incl. hexasialotransferrin) ClinChek Controls: 218 Serum Control, lyophil., Level I 1 x 1 ml 2181 Serum Control, lyophil., Level II 1 x 1 ml 2182 Serum Control, lyophil., Level I, II 2 x 5 x 1 ml Baseline-separation of disialotransferrin 13

9 This ClinRep Complete Kit is designed for the fast analysis of CDT with on-line HPLC. It features an injection interval of 9.5 min only and provides a unique chromatographical resolution compared to other commercially available test kits. Analogously to our CDT off-line method (see pages 12-13), the online procedure correlates with the candidate reference method of the IFCC-CDT-WG*. Prior to the sample injection, a simple dilution step is required ( sample pretreatment, see below). Alternatively, the dilution can be performed automated via 96- well plates. For this purpose an additional ClinRep Complete Kit is available (see pages 16-17). * Working group of the IFCC for the international standardisation of CDT measurement. Alcoholism, Drug Abuse CDT in Serum On-Line Analysis Test Data LLOD:.1 %* LLOQ:.3 %* Intraassay precision: 4.5 % Interassay precision: 3.9 % * depending on the amount of total transferrin and on detector sensitivity Native sample, normal range Disialotransferrin: 4.5 min, Trisialotransferrin: 5.17 min, Tetrasialotransferrin: 6.17 min, Pentasialotransferrin: 7.13 min, Hexasialotransferrin: 7.86 min Native sample, pathological range Asialotransferrin: 3.2 min, Disialotransferrin: 4.52 min, Trisialotransferrin: 5.19 min, Tetrasialotransferrin: 6.21 min, Pentasialotransferrin: 7.15 min, Hexasialotransferrin: 7.84 min Diagnostics One step sample pretreatment Fast analysis: injection interval of 9.5 min only Unique chromatographical quality HPLC Parameters Pump 1: binary gradient pump, flow rate: 1.4 ml/min Pump 2: isocratic pump, flow rate:.4 ml/min Injection volume: 4-5 μl Injection interval: 9.5 min UV/VIS-Detector: 46 nm HPLC-Thermostat: 4 C Sample Pretreatment Dilution: Pipette 1 μl serum into a pretreatment vial (contains 1 ml diluting solution) 1. incubate (3 min, 4 C) HPLC Analysis: Inject 4-5 μl 2. centrifuge 211 ClinRep Complete Kit for CDT in Serum for 3 assays Kit Components (order no. 211): 217 Mobile Phase A 3 x 217 (3 x 2 ml) 218 Mobile Phase B 2 ml 219 Mobile Phase C 2 x 219 (2 x 2 ml) 2112 Vials for Sample Pretreatment with Diluting Solution 6 x 2112 (6 x 5 pcs.) Manual Quick Reference Optional Components: 2114 Test Solution 15 ml Start Accessories: 213 Analytical Column with test chromatogram 2132 Cartridge incl. 1 precolumn FK582 Stainless steel prefilter holder FK74 Inline-Filter (stainless steel sieve, free of dead volume) Refill Service: 2131 Analytical Column with test chromatogram (original column needs to be returned) Accessories: 2133 Precolumn 5 pcs. FK112 Switching valve, Sykam (6-port/3-channel incl. electr. drive, PEEK) FK535 Sample loop, PEEK, 5 μl FK581 PEEK tubing (connection of prefilter and column) FK5821 Replacement filter for stainless steel prefilter holder 1 pcs. FK733 Endfittings 2 pcs. FK734 Sealings and sieves 4 pcs. each FK735 Endstoppers 2 pcs. FW3 Fixed-Wavelength-VIS-Detector (46 nm), complete RC22 Sodium-Hypochlorite-Solution (5 %) 12 ml ClinChek Controls: 218 Serum Control, lyophil., Level I 1 x 1 ml 2181 Serum Control, lyophil., Level II 1 x 1 ml 2182 Serum Control, lyophil., Level I, II 2 x 5 x 1 ml 15

10 This ClinRep Complete Kit from RECIPE is designed for the fast, reliable and fully automated quantification of CDT. Sample preparation is performed by on-line HPLC and automated sample pretreatment using 96-well plates. The kit provides a unique chro - ma tographical resolution compared to other commercially available test kits. The analytical method correlates with the candidate reference method of the IFCC-CDT-WG* and ensures a reliable separation of all relevant transferrin isoforms (a-, mono-, di-,, hexasialotransferrin). This applies in particular for disialotransferrin, the most important CDT isoform. An accurate calculation of the CDT value is ensured by baseline separation. * Working group of the IFCC for the international standardisation of CDT measurement. Alcoholism, Drug Abuse CDT in Serum Automated On-Line Analysis Test Data LLOD:.1 %* LLOQ:.3 %* Intraassay precision: 2.8 % Interassay precision: 2.5 % * depending on the amount of total transferrin and on detector sensitivity Native sample, normal range Disialotransferrin: 4.5 min, Trisialotransferrin: 5.17 min, Tetrasialotransferrin: 6.17 min, Pentasialotransferrin: 7.13 min, Hexasialotransferrin: 7.86 min Native sample, pathological range Asialotransferrin: 3.2 min, Disialotransferrin: 4.52 min, Trisialotransferrin: 5.19 min, Tetrasialotransferrin: 6.21 min, Pentasialotransferrin: 7.15 min, Hexasialotransferrin: 7.84 min Diagnostics HPLC Parameters Pump 1: binary gradient pump, flow rate: 1.4 ml/min Pump 2: isocratic pump, flow rate:.4 ml/min Injection volume: 4 μl Injection interval: 9.5 min UV/VIS-Detector: 46 nm HPLC-Thermostat: 4 C 212 ClinRep Complete Kit for CDT in Serum for 3 assays Kit Components (order no. 212): 217 Mobile Phase A 3 x 217 (3 x 2 ml) 218 Mobile Phase B 2 ml 219 Mobile Phase C 2 x 219 (2 x 2 ml) D Diluting Solution 3 x (3 x 5 ml) Manual Quick Reference Optional Components: 2114 Test Solution 15 ml Sample Pretreatment (automated, 96-well plates) Dilution: 5 μl Diluting Solution D 5 μl serum Start Accessories: 213 Analytical Column with test chromatogram 2132 Cartridge incl. 1 precolumn FK582 Stainless steel prefilter holder FK74 Inline-Filter (stainless steel sieve, free of dead volume) Fully automated method (96-well plates) Fast analysis: injection interval of 9.5 min only Unique chromatographical resolution 1. incubate (3 min, 4 C) On-Line Analysis: Inject 4 μl 2. centrifuge Refill Service: 2131 Analytical Column with test chromatogram (original column needs to be returned) Accessories: 2133 Precolumns 5 pcs Deepwell plate 96/5μl 8 pcs. FK112 Switching valve, Sykam (6-port/3-channel incl. electr. drive, PEEK) FK535 Sample loop, PEEK, 5 μl FK581 PEEK tubing (connection of prefilter and column) FK5821 Replacement filter for stainless steel prefilter holder 1 pcs. FK733 Endfittings 2 pcs. FK734 Sealings and sieves 4 pcs. each FK735 Endstoppers 2 pcs. FW3 Fixed-Wavelength-VIS-Detector (46 nm), complete RC22 Sodium-Hypochlorite-Solution (5 %) 12 ml ClinChek Controls: 218 Serum Control, lyophil., Level I 1 x 1 ml 2181 Serum Control, lyophil., Level II 1 x 1 ml 2182 Serum Control, lyophil., Level I, II 2 x 5 x 1 ml 17

11 This ClinRep Reagent Kit is intended for use with the TOX.I.S. System from Shimadzu, an on-line Alcoholism, Drug Abuse Chromatogram of the ClinTest Test Solution Diagnostics HPLC system which has been designed for automated drug screening (on-line analysis). The analytical method allows for the reliable scree - ning of more than 3 illegal drugs, such as morphine, methadone, and amphetamine. Basic Drugs in Urine On-Line Analysis mau RECIPE and Shimadzu are offering a complete solution for the screening of illegal drugs in urine The TOX.I.S. system from Shimadzu is an on-line HPLC-system with photodiode array detection. It has been designed for the qualitative (and semiquantitative) screening for acute poisoning, drug abuse and doping. The RECIPE reagent kit ensures a reliable and stan - d ardised HPLC analysis with Shimadzuʼs TOX.I.S. system and contains buffers, an internal stan dard, and a test solution. Also, columns and accessories are provided. Shimadzuʼs analytical method allows for an automated screening of more than 3 alka line* drugs of abuse. The analyte identification bases on the comparison of retention times and UV spectra. For this purpose, the evaluation software of the system provides an extensive UV spectra library. * For the drug screening of acidic, neutral, and weak alkaline phar maceuticals, additional reagent kits for the analysis from urine and plasma are available (see pages 2-21). MDA: min, Amphetamine: min, 6-Acetylmorphine: min, Methadone: min, Morphine: min, Tilidine: min, Codeine: min, EDDP: min, IS: 4.9 min 6 ClinRep Reagent Kit for the TOX.I.S. System from Shimadzu for 1 assays Kit Components (order no. 6): 67 Mobile Phase A 25 ml 68 Mobile Phase B 5 ml 69 SPE-Buffer 25 ml 612 IS Internal Standard 5 ml 614 Test Solution 2 x 614 (2 x 15 ml) 621 SPE-Washing Solution 2 x 621 (2 x 25 ml) Additional Components: 66 Mobile Phase AB 25 ml Start Accessories: 63 Analytical Column with test chromatogram 631 SPE-Column Holder incl. 1 SPE-Column 632 SPE-Column 633 Guard Column Holder incl. 1 Guard Column 634 Guard Columns 1 pcs. 19

12 These ClinRep Reagent Kits are intended for use with the TOX.I.S. System from Shimadzu, an on- Alcoholism, Drug Abuse Chromatogram of the ClinTest Test Solution Diagnostics line HPLC system, which has been designed for automated drug screening (on-line analysis). Shimadzu's analytical method provides automated determination of more than 5 different pharmaceuticals from plasma and urine. Pharmaceuticals in Plasma and Urine On-Line Analysis mau RECIPE and Shimadzu are offering a complete so - lution for the screening of illegal drugs from plasma (order no. 62) and urine (order no. 61). The TOX.I.S. System from Shimadzu is an on-line HPLC-system with photodiode array detection. It has been designed for the qualitative (and semiquantitative) screening on acute poisoning, drug abuse and doping. Both RECIPE reagent kits ensure a reliable and standardised HPLC analysis with Shimadzuʼs TOX.I.S. System and contain buffers, an internal standard, a test solution, and a reagent for sample pretreatment. Columns and accessories are additionally available. Shimadzuʼs analytical method allows for an automated drug screening of more than 5 pharmaceutical compounds* with sedative and hypnotic properties and high potential of abuse. The analyte identification bases on the comparison of retention times and UV spectra. For this purpose, the evaluation software of the system provides an extensive UV spectra library. * Compounds with acidic, neutral, and weak alkaline properties. For the screening of illegal alkaline drugs, such as morphine, methadone, and amphetamine, an additional reagent kit is offered (see pages 18-19). Pharmaceuticals in Plasma On-Line Analysis Doxylamine: 12. min, Norclozapine: 17.5 min, Doxepin: 23.7 min, Carbamazepine: 27.1 min, Oxazepam: 28.9 min, Temazepam: 33.7, IS: 38.6 min 62 ClinRep Reagent Kit for the TOX.I.S. System from Shimadzu for 1 assays Kit Components (order no. 62): 67 Mobile Phase A 25 ml 68 Mobile Phase B 5 ml 619 SPE-Buffer 25 ml 6212 IS Internal Standard 3 ml 6114 Test Solution 2 x 6114 (2 x 15 ml) 621 SPE-Washing Solution 25 ml 6221 D Diluting Solution 1 ml Start Accessories: 613 Analytical Column with test chromatogram 6131 SPE-Column Holder incl. 1 SPE-Column 6132 SPE-Column 6133 Guard Column Holder incl. 1 Guard Column 6134 Guard Columns 1 pcs. Pharmaceuticals in Urine On-Line Analysis 61 ClinRep Reagent Kit for the TOX.I.S. System from Shimadzu for 1 assays Kit Components (order no. 61): 67 Mobile Phase A 25 ml 68 Mobile Phase B 5 ml 619 SPE-Buffer 25 ml 6112 IS Internal Standard 5 ml 6114 Test Solution 2 x 6114 (2 x 15 ml) 621 SPE-Washing Solution 25 ml 6122 Enzyme Solution 1 ml 4 Start Accessories: 613 Analytical Column with test chromatogram 6131 SPE-Column Holder incl. 1 SPE-Column 6132 SPE-Column 6133 Guard Column Holder incl. 1 Guard Column 6134 Guard Columns 1 pcs. 21

13 Epinephrine (E), norepinephrine (NE), and dopamine (D) are termed as catecholamines. The determination of catecholamines is primarily used for helping to detect and rule out pheochromocytomas in symp - to matic patients, i.e. in patients with persistent hypertension. It is also used in order to help monitor for recurrence when a pheochromocytoma has been discovered and removed. For these purposes, this ClinRep Complete Kit allows for a quick and safe quan ti fication of the catecholamines. The kit is easy to use and is characterised by an extraordinarily good lower detection limit. Biogenic Amines Catecholamines in Plasma Test Data Linearity: 1-25 ng/l Recovery: 7-9 % LLOD: 5 ng/l LLOQ: 1 ng/l Intraassay precision: 6.7 % (NE), 7.6 % (E), 6.1 % (D) Interassay precision: 5.3 % (NE), 4.2 % (E), 3.9 % (D) HPLC Parameters Pump: Injection volume: Injection interval: EC-Detector: Temperature: isocratic pump, flow rate: 1. ml/min 4 μl 15 min potential: 5 mv, sensitivity: 1 na 25 C (or ambient) ClinChek Plasma Control, Level I Norepinephrine: 4.28 min, Epinephrine: 5.8 min, IS: 7.55 min, Dopamine: 12.5 min ClinChek Plasma Control, Level II Norepinephrine: 4.28 min, Epinephrine: 5.7 min, IS: 7.56 min, Dopamine: 12.2 min 1 ClinRep Complete Kit for Catecholamines in Plasma for 25 assays Kit components (order no. 1): 121 Mobile Phase 1 ml 111 Standard Solution 1 ml 112 IS Internal Standard 15 ml 113 Plasma Calibrator, lyophil. 5 x 5 ml 12 Sample Preparation Columns incl. elution vials 5 x 12 (5 x 5 pcs.) 121 W Washing Solution 3 x 121 (3 x 25 ml) 122 E Eluting Reagent 3 ml Manual Quick Reference Start Accessories: 13 Analytical Column with test chromatogram Diagnostics Sample Preparation Extraction: Elution: Apply 1 ml plasma and 5 μl Internal Standard IS to a sample preparation column wash (3 x 1 ml Washing Solution W) Accessories: ml sample vial with cap for storing samples 5 pcs. 142 Sampling system for Plasma Catecholamines (5 ml) 5 pcs. 16 Sample preparation column, empty with frit and cap 5 pcs μl elution vial with cap 5 pcs. 17 Alumina oxide 5 g 171 Microspatula M Tris Buffer 25 ml Reliable sample preparation HPLC Analysis: Elute with 12 μl Eluting Reagent E collect the eluate ClinChek Controls: 881 Plasma Control, lyophil., Level I 1 x 5 ml 8811 Plasma Control, lyophil., Level II 1 x 5 ml 889 Plasma Control, lyophil., Level I, II 2 x 5 x 5 ml Inject 4 μl Quick and safe quantification Detection limit: 5 ng/l 23

14 With this complete kit, the determination of norepin - ephrine (NE), epinephrine (E), and dopamine (D) is performed from urine. The sample preparation features particular user friendliness for laboratory routine. For a safe and convenient check-up of the phvalue prior to sample extraction, a special stabilising reagent with colour indicator is available. The dis - tinct indicator colouring assures the setting of the appropriate ph value range (ph 2 5). Alter na tively to this method with manual sample preparation, RECIPE offers ClinRep Complete Kits for use with automatic pipetting systems from Gilson (see pages 26-27) and HTA (see pages 28-29). Biogenic Amines Catecholamines in Urine Test Data Linearity: 2-1 μg/l Recovery: 7-85 % LLOD / LLOQ: 1 μg/l / 2 μg/l Precision Intraassay:.8 % (NE), 1.4 % (E), 1.7 % (D) Interassay: 2. % (NE), 2.3 % (E), 3.1 % (D) ClinChek Urine Control, Level I Norepinephrine: 4.89 min, Epinephrine: 5.89 min, IS: 8.33 min, Dopamine: min ClinChek Urine Control, Level II Norepinephrine: 4.89 min, Epinephrine: 5.89 min, IS: 8.33 min, Dopamine: min Diagnostics HPLC Parameters Isocratic Pump: flow rate: 1. ml/min Injection vol. / int.: 2 μl / 15 min EC-Detector: pot.: 5 mv, sen.: 1 na HPLC-Thermostat: 3 C Sample Preparation Addition of IS / ph adjustment: 3 ml urine 5 ml Stab. Reagent S (contains colour indic.) 3 μl Internal Standard IS 2 ClinRep Complete Kit for Catecholamines in Urine for 1 assays Kit Components (order no. 2): 121 Mobile Phase 1 ml 211 Standard Solution 1 ml 212 IS Internal Standard 3 ml 213 Urine Calibrator, lyophil. 5 x 8 ml 22 Sample Preparation Columns 2 x 22 (2 x 5 pcs.) 221 S Stabilising Reagent 5 ml 224 E Eluting Reagent 2 x 224 (2 x 3 ml) Manual Quick Reference Extraction: adjust with 1 M NaOH, until the indicator switches to yellow ph = 1.5 ph = 2.5 ph = 3.5 ph = 4.5 ph = 5.5 ph = 6. ph = 8. + NaOH - HCI ph < 2. too acidic ph = < ph < 5. ok ph = 5. ph > 5. too alkaline Start Accessories: 23 Analytical Column with test chromatogram Accessories: FK4 Column Rack (for 2 columns) ClinChek Controls: 882 Urine Control, lyophil., Level I 1 x 8 ml 8821 Urine Control, lyophil., Level II 1 x 8 ml 8822 Urine Control, lyophil., Level I, II 2 x 5 x 8 ml Safe and convenient ph-adjustment Robust chromatography Elution: HPLC Analysis: Apply the whole sample on the sample preparation column wash (HPLC water) Apply 6 ml Eluting Reagent E Inject 2 μl Detection limit: 1 μg/l 25

15 Norepinephrine (NE), epinephrine (E), and dopamine (D) are termed as catecholamines. As an alternative to the determination with manual sample preparation (see pages 24-25), RECIPE offers appropriate ClinRep Complete Kits for use with automatic pipetting systems from HTA (see pages 28-29) and Gilson. With the Gilson ASPEC XL, the sample preparation and -injection is performed automatically. In advance, the ph value of the sample is checked by use of a stabilising reagent with colour indicator (manual sample pretreatment). Biogenic Amines Catecholamines in Urine with Gilson ASPEC XL Test Data Linearity: 2-1 μg/l Recovery: % LLOD / LLOQ: 1 μg/l / 2 μg/l Precision Intraassay: 1.2 % (NE), 1.5 % (E), 1.5 % (D) Interassay: 2.7 % (NE), 2.6 % (E), 4.2 % (D) ClinChek Urine Control, Level I Norepinephrine: 4.89 min, Epinephrine: 5.89 min, IS: 8.33 min, Dopamine: min ClinChek Urine Control, Level II Norepinephrine: 4.89 min, Epinephrine: 5.89 min, IS: 8.33 min, Dopamine: min Diagnostics HPLC Parameters Isocratic Pump: flow rate: 1. ml/min Injection vol. / int.: 2 μl / 15 min EC-Detector: pot.: 5 mv, sen.: 1 na HPLC-Thermostat: 3 C Sample Preparation Manual sample pretreatment ph adjustment: 22 ClinRep Complete Kit for Catecholamines in Urine for 1 assays (Automated Sample Preparation with Gilson ASPEC XL) Kit components (order no. 22): 121 Mobile Phase 1 ml 211 Standard Solution 1 ml 212 IS Internal Standard 3 ml 213 Urine Calibrator, lyophil. 5 x 8 ml 222 Sample Preparation Columns 2 x 222 (2 x 5 pcs.) 221 S Stabilising Reagent 5 ml 2224 E Eluting Reagent 4 ml Manual Quick Reference 3 ml urine 5 ml Stabilising Reagent S (contains colour indicator) 23 ClinRep Complete Kit for Catecholamines in Urine for 5 assays (Automated Sample Preparation with Gilson ASPEC XL) Automated sample preparation Test kits available for 1 or 5 assays Extraction: adjust with 1 M NaOH, until the indicator switches to yellow ph = 1.5 ph = 2.5 ph = 3.5 ph = 4.5 ph = 5.5 ph = 6. ph = 8. + NaOH - HCI ph < 2. too acidic ph = 2. Addition of IS: 2. < ph < 5. ok Automated sample preparation with Gilson ASPEC XL ph = 5. ph > 5. too alkaline Add 3 μl Internal Standard IS to the sample Apply 6 ml sample on the sample preparation column Kit components (order no. 23): 121 Mobile Phase 5 x 121 (5 x 1 ml) 211 Standard Solution 5 x 211 (5 x 1 ml) 212 IS Internal Standard 5 x 212 (5 x 3 ml) 213 Urine Calibrator, lyophil. 5 x 213 (5 x 5 x 8 ml) 222 Sample Preparation Columns 1 x 222 (1 x 5 pcs.) 221 S Stabilising Reagent 5 x 221 (5 x 5 ml) 2224 E Eluting Reagent 5 x 2224 (5 x 4 ml) Manual Quick Reference Start Accessories: 23 Analytical Column with test chromatogram ClinChek Controls: 882 Urine Control, lyophil., Level I 1 x 8 ml 8821 Urine Control, lyophil., Level II 1 x 8 ml 8822 Urine Control, lyophil., Level I, II 2 x 5 x 8 ml Elution: wash (HPLC water) Injection interval: 15 min Apply 4 ml Eluting Reagent E HPLC Analysis: Inject 2 μl 27

16 Norepinephrine (NE), epinephrine (E), and dopamine (D) are termed as catecholamines. As an alternative to the determination with manual sample preparation (see pages 24-25), RECIPE offers appropriate ClinRep Complete Kits for use with automatic pipetting systems from Gilson (see pages 26-27) and HTA. With the HT4E from HTA, the sample preparation and -injection is performed auto - matically. In advance, the ph value of the sample is checked by use of a stabilising reagent with colour indicator (manual sample pretreatment). Biogenic Amines Catecholamines in Urine with HTA, Model HT4E Test Data Linearity: 2-1 μg/l Recovery: 9 % LLOD / LLOQ: 1 μg/l / 2 μg/l Precision Intraassay: 1.8 % (NE), 2. % (E), 1.8 % (D) Interassay: 2.5 % (NE), 2.3 % (E), 3.4 % (D) ClinChek Urine Control, Level I Norepinephrine: 4.89 min, Epinephrine: 5.89 min, IS: 8.33 min, Dopamine: min ClinChek Urine Control, Level II Norepinephrine: 4.89 min, Epinephrine: 5.89 min, IS: 8.33 min, Dopamine: min Diagnostics Automated sample preparation HPLC Parameters Isocratic Pump: flow rate: 1. ml/min Injection vol. / int.: 2 μl / 15 min EC-Detector: pot.: 5 mv, sen.: 1 na HPLC-Thermostat: 3 C Sample Preparation Manual sample pretreatment ph adjustment: 1.5 ml urine adjust with 1 M NaOH, until the indicator switches to yellow ph = 1.5 ph = 2.5 ph = 3.5 ph = 4.5 ph = 5.5 ph = 6. ph = 8. + NaOH - HCI ph < 2. too acidic ph = 2. Addition of IS: 2. < ph < 5. ok Automated sample preparation with HT4E 2.5 ml Stabilising Reagent S (contains colour indicator) ph = 5. ph > 5. too alkaline Add 2 μl Internal Standard IS to the sample 24 ClinRep Complete Kit for Catecholamines in Urine for 1 assays (Automated Sample Preparation with HT4E) Kit components (order no. 24): 121 Mobile Phase 1 ml 211 Standard Solution 1 ml 212 IS Internal Standard 3 ml 213 Urine Calibrator, lyophil. 5 x 8 ml 242 Sample Preparation Columns 2 x 242 (2 x 5 pcs.) 2421 S Stabilising Reagent 25 ml 2424 E Eluting Reagent 25 ml FK641 Sample vials, clear glass, 4ml 2 x FK641 (2 x 1 pcs.) Manual Quick Reference 25 ClinRep Complete Kit for Catecholamines in Urine for 5 assays (Automated Sample Preparation with HT4E) Kit components (order no. 25): 121 Mobile Phase 5 x 121 (5 x 1 ml) 211 Standard Solution 5 x 211 (5 x 1 ml) 212 IS Internal Standard 5 x 212 (5 x 3 ml) 213 Urine Calibrator, lyophil. 5 x 213 (5 x 5 x 8 ml) 242 Sample Preparation Columns 1 x 242 (1 x 5 pcs.) 2421 S Stabilising Reagent 5 x 2421 (5 x 25 ml) 2424 E Eluting Reagent 5 x 2424 (5 x 25 ml) FK641 Sample vials, clear glass, 4ml 1 x FK641 (1 x 1 pcs.) Manual Quick Reference Start Accessories: 23 Analytical Column with test chromatogram Test kits available for 1 or 5 assays Extraction: Apply 3.6 ml sample on the sample preparation column ClinChek Controls: 882 Urine Control, lyophil., Level I 1 x 8 ml 8821 Urine Control, lyophil., Level II 1 x 8 ml 8822 Urine Control, lyophil., Level I, II 2 x 5 x 8 ml Elution: wash (HPLC water) Injection interval: 15 min Apply 2.5 ml Eluting Reagent E HPLC Analysis: Inject 2 μl 29

17 This test kit is designed for the automated analysis of the catecholamines. A manual sample preparation is not required, but is performed on-line within the HPLC system! Biogenic Amines Catecholamines in Urine On-Line Analysis ClinChek Urine Control, Level I (+ 2 μl IS/ml urine) ClinChek Urine Control, Level II (+ 2 μl IS/ml urine) Diagnostics On-line sample preparation Robust chromatography with fluorescence detection Test Data Linearity: 3-15 μg/l Recovery: 95-1 % LLOD: 1 μg/l LLOQ: 3 μg/l Intraassay precision: 3. % (NE), 4.5 % (E),.8 % (D) Interassay precision: 3.6 % (NE), 6.4 % (E), 2.4 % (D) HPLC Parameters Pump 1 (SPE buffer): isocratic pump, flow rates:.5, 2. ml/min Pump 2 (mobile phase): isocratic pump, flow rate: 1.2 ml/min Switching valve: 6-port/3-channel switching valve (order no. FK112) Injection volume: 5 μl Injection interval: 2 min Fluorescence detector: 275 nm (exc.), 33 nm (em.) HPLC-Thermostat: 3 C Sample Pretreatment Addition of IS: On-Line Analysis: Add 2 μl Internal Standard IS/ml urine centrifuge Norepinephrine: 9.12 min, Epinephrine: 1.52 min, IS: min, Dopamine: min Norepinephrine: 9.11 min, Epinephrine: 1.51 min, IS: min, Dopamine: 16.1 min 21 ClinRep Complete Kit for Catecholamines in Urine for 5 assays Kit components (order no. 21): 219 SPE - Buffer 4 x 219 (4 x 25 ml) 211 Mobile Phase 6 x 211 (6 x 25 ml) 211 Standard Solution 1 ml 2113 Urine Calibrator (FD), lyophil. 5 x 5 ml Manual Quick Reference Optional components: 212 IS Internal Standard 3 ml Start Accessories: 1232 Guard Column Holder 1233 Guard Column 4 pcs. 213 Analytical Column with test chromatogram 2131 SPE - Column FK581 PEEK capillary connector FK582 Stainless steel prefilter holder FK74 Inline-Filter (stainless steel sieve, free of dead volume) Accessories: FK112 Switching valve, Sykam (6-port/3-channel incl. electr. drive, PEEK) FK5821 Replacement filter for stainless steel prefilter holder 1 pcs. FK733 Endfittings 2 pcs. FK734 Sealings and sieves 4 pcs. each FK735 Endstoppers 2 pcs. ClinChek Controls: 218 Urine Control (FD), lyophil., Level I 1 x 5 ml 2181 Urine Control (FD), lyophil., Level II 1 x 5 ml 2182 Urine Control (FD), lyophil., Level I, II 2 x 5 x 5 ml Inject 5 μl NE: Norepinephrine E: Epinephrine D: Dopamine 31

18 Metanephrines, i.e. metanephrine (M), normetane - phrine (NM), and 3-methoxytyramine (MT), are the primary meta bolites of the catecholamines. Similar to the catecholamines, the determination of the meta - nephrines is used to detect or rule out tumors of the sympathoadrenal system. For this purpose, this test kit of RECIPE features particular user friendlyness within sample preparation. For a safe and convenient check-up of the ph-value prior to sample extraction, a special diluting solution with colour indicator is available. The distinct colouring of the indicator assures that the analyte extraction is performed under appropriate ph conditions (ph > 6). Also available: Test kits for automated sample preparation (see pages 34-37). Biogenic Amines Metanephrines in Urine Test Data Linearity: 8-1 μg/l Recovery: 6 % LLOD / LLOQ: 5 μg/l / 8 μg/l Precision Intraassay: 1.7 % (NM), 3. % (M), 2.5 % (MT) Interassay: 1.8 % (NM), 2.9 % (M), 1.9 % (MT) HPLC Parameters Isocratic Pump: flow rate: 1. ml/min Injection vol. / int.: 2 μl / 17 min EC-Detector: pot.: 65 mv, sen.: 5 na HPLC-Thermostat: 3 C Sample Preparation Hydrolysis: 1 ml urine 2 μl Internal Standard IS 1. adjust ph to incubate (3 min, 9-1 C) ClinChek Urine Control, Level I Normetanephrine: 5.26 min, Metanephrine: 6.47 min, IS: 9.43 min, 3-Methoxytyramine: 15.3 min ClinChek Urine Control, Level II Normetanephrine: 5.25 min, Metanephrine: 6.48 min, IS: 9.42 min, 3-Methoxytyramine: 15.3 min 4 ClinRep Complete Kit for Metanephrines in Urine for 1 assays Kit components (order no. 4): 41 Mobile Phase 1 ml 411 Standard Solution 1 ml 412 IS Internal Standard 3 ml 413 Urine Calibrator, lyophil. 5 x 8 ml 42 Sample Preparation Columns 2 x 42 (2 x 5 pcs.) 422 D Diluting Solution 4 ml 423 W Washing Solution 4 ml 424 E Eluting Reagent 2 x 424 (2 x 25 ml) 425 S Stabilising Reagent 1 ml Manual Quick Reference Diagnostics ph adjustment: Add 4 ml Diluting Solution D (contains colour indicator) Start Accessories: 43 Analytical Column with test chromatogram check, if the sample is yellow (ph > 6) if necessary, add 1 M NaOH dropwise Accessories: FK4 Column Rack (for 2 columns) FK63 Reagent tube (1 x 16 mm) with screw cap and o-ring, PP, autoclavable up to 121 C 5 pcs. Safe and convenient ph-adjustment Extraction: ph = 4.5 ph = 5. ph = 5.5 ph = 6.5 ph = 7. ph = NaOH ph < 6. too acidic ph = 6. ph > 6. ok ClinChek Controls: 882 Urine Control, lyophil., Level I 1 x 8 ml 8821 Urine Control, lyophil., Level II 1 x 8 ml 8822 Urine Control, lyophil., Level I, II 2 x 5 x 8 ml Apply the whole sample on the sample preparation column Robust chromatography Elution: wash (HPLC water and Washing Solution W) Elute with 5 ml Eluting Reagent E (receiver vial: 1 ml Stabilising Reagent S) Low cost per test HPLC Analysis: collect the eluate Inject 2 μl 33

19 Normetanephrine (NM), metanephrine (M), and 3-me thoxytyramine (MT) are termed as metan - ephrines. As an alternative to the determination with manual sample preparation (see pages 32-33), RECIPE offers appropriate ClinRep Complete Kits for use with auto matic pipetting systems from HTA (see pages 36-37) and Gilson. With the Gilson ASPEC XL, the sample preparation and injection is performed automatically. In advance, the samples are hydrolysed in order to ensure a quantitative release of sulfateester and glucuronide bound uri - nary metanephrines (manual sample pretreatment). Biogenic Amines Metanephrines in Urine with Gilson ASPEC XL Test Data Linearity: 6-1 μg/l Recovery: 72 % LLOD / LLOQ: 4 μg/l / 6 μg/l Precision Intraassay: 1.2 % (NM), 1.4 % (M), 1.9 % (MT) Interassay: 1.9 % (NM), 2.2 % (M), 3. % (MT) ClinChek Urine Control, Level I Normetanephrine: 5.26 min, Metanephrine: 6.47 min, IS: 9.43 min, 3-Methoxytyramine: 15.3 min ClinChek Urine Control, Level II Normetanephrine: 5.25 min, Metanephrine: 6.48 min, IS: 9.42 min, 3-Methoxytyramine: 15.3 min Diagnostics HPLC Parameters Isocratic Pump: flow rate: 1. ml/min Injection vol. / int.: 2 μl / 17 min EC-Detector: pot.: 65 mv, sen.: 5 na HPLC-Thermostat: 3 C Sample Preparation Manual sample pretreatment Hydrolysis: 1 ml urine 2 μl Internal Standard IS 41 ClinRep Complete Kit for Metanephrines in Urine for 1 assays (Automated Sample Preparation with Gilson ASPEC XL) Kit components (order no. 41): 41 Mobile Phase 1 ml 411 Standard Solution 1 ml 412 IS Internal Standard 3 ml 413 Urine Calibrator, lyophil. 5 x 8 ml 412 Sample Preparation Columns 2 x 412 (2 x 5 pcs.) 422 D Diluting Solution 4 ml 423 W Washing Solution 4 ml 4124 E Eluting Reagent 25 ml 4125 S Stabilising Reagent 8 ml Manual Quick Reference Automated sample preparation 1. adjust ph to.5-1. ph adjustment: 2. incubate (3 min, 9-1 C) Add 4 ml Diluting Solution D (contains colour indicator) check, if the sample is yellow (ph > 6) if necessary, add 1 M NaOH dropwise ph = 4.5 ph = 5. ph = 5.5 ph = 6.5 ph = 7. ph = NaOH ph < 6. too acidic ph = 6. ph > 6. ok 42 ClinRep Complete Kit for Metanephrines in Urine for 5 assays (Automated Sample Preparation with Gilson ASPEC XL) Kit components (order no. 42): 41 Mobile Phase 5 x 41 (5 x 1 ml) 411 Standard Solution 5 x 411 (5 x 1 ml) 412 IS Internal Standard 5 x 412 (5 x 3 ml) 413 Urine Calibrator, lyophil. 5 x 413 (5 x 5 x 8 ml) 412 Sample Preparation Columns 1 x 412 (1 x 5 pcs.) 422 D Diluting Solution 5 x 422 (5 x 4 ml) 423 W Washing Solution 5 x 423 (5 x 4 ml) 4124 E Eluting Reagent 5 x 4124 (5 x 25 ml) 4125 S Stabilising Reagent 5 x 4125 (5 x 8 ml) Manual Quick Reference Test kits available for 1 or 5 assays Automated sample preparation with Gilson ASPEC XL Extraction: Elution: Apply 2.5 ml sample to the sample preparation column wash (HPLC water and Washing Solution W) Elute with 2.5 ml Eluting Reagent E (receiver vial: 8 μl Stabilising Reagent S) Start Accessories: 43 Analytical Column with test chromatogram Accessories: FK63 Reagent tube (1 x 16 mm) with screw cap and o-ring, PP, autoclavable up to 121 C 5 pcs. ClinChek Controls: 882 Urine Control, lyophil., Level I 1 x 8 ml 8821 Urine Control, lyophil., Level II 1 x 8 ml 8822 Urine Control, lyophil., Level I, II 2 x 5 x 8 ml HPLC Analysis: collect the eluate Inject 2 μl 35

20 Normetanephrine (NM), metanephrine (M), and 3-methoxytyramine (MT) are termed as metan - ephrines. As an alternative to the determination with manual sample preparation (see pages 32-33), RECIPE offers appropriate test kits for use with automatic pipetting sys tems from Gilson (see pages 34-35) and HTA. With the HT4E from HTA the sample preparation and injection is per - formed automatically. In advance, the samples are hydrolysed in order to ensure a quantitative re lease of sulfateester and glucuronide bound uri nary metanephrines (manual sample pretreatment). Biogenic Amines Metanephrines in Urine with HTA, Model HT4E Test Data Linearity: 7-1 μg/l Recovery: 98 % LLOD / LLOQ: 4 μg/l / 7 μg/l Precision Intraassay: 1. % (NM), 1.5 % (M), 1.8 % (MT) Interassay: 1. % (NM), 2.6 % (M), 2.9 % (MT) ClinChek Urine Control, Level I Normetanephrine: 5.26 min, Metanephrine: 6.47 min, IS: 9.43 min, 3-Methoxytyramine: 15.3 min ClinChek Urine Control, Level II Normetanephrine: 5.25 min, Metanephrine: 6.48 min, IS: 9.42 min, 3-Methoxytyramine: 15.3 min Diagnostics HPLC Parameters Isocratic Pump: flow rate: 1. ml/min Injection vol. / int.: 2 μl / 17 min EC-Detector: pot.: 65 mv, sen.: 5 na HPLC-Thermostat: 3 C Sample Preparation Manual sample pretreatment Hydrolysis: 1 ml urine 2 μl Internal Standard IS 43 ClinRep Complete Kit for Metanephrines in Urine for 1 assays (Automated Sample Preparation with HT4E) Kit components (order no. 43): 41 Mobile Phase 1 ml 411 Standard Solution 1 ml 412 IS Internal Standard 3 ml 413 Urine Calibrator, lyophil. 5 x 8 ml 432 Sample Preparation Columns 2 x 432 (2 x 5 pcs.) 422 D Diluting Solution 4 ml 4323 W Washing Solution 5 ml 4124 E Eluting Reagent 25 ml 4125 S Stabilising Reagent 8 ml FK641 Sample vials, clear glass, 4ml 2 x FK641 (2 x 1 pcs.) Manual Quick Reference 1. adjust ph to.5-1. ph adjustment: 2. incubate (3 min, 9-1 C) 44 ClinRep Complete Kit for Metanephrines in Urine for 5 assays (Automated Sample Preparation with HT4E) Automated sample preparation Test kits available for 1 or 5 assays Extraction: Elution: Add 4 ml Diluting Solution D (contains colour indicator) check, if the sample is yellow (ph > 6) Apply 2.5 ml sample to the sample preparation column if necessary, add 1 M NaOH dropwise ph = 4.5 ph = 5. ph = 5.5 ph = 6.5 ph = 7. ph = NaOH ph < 6. too acidic ph = 6. Automated sample preparation with HT4E ph > 6. ok wash (HPLC water and Washing Solution W) Kit components (order no. 44): 41 Mobile Phase 5 x 41 (5 x 1 ml) 411 Standard Solution 5 x 411 (5 x 1 ml) 412 IS Internal Standard 5 x 412 (5 x 3 ml) 413 Urine Calibrator, lyophil. 5 x 413 (5 x 5 x 8 ml) 432 Sample Preparation Columns 1 x 432 (1 x 5 pcs.) 422 D Diluting Solution 5 x 422 (5 x 4 ml) 4323 W Washing Solution 5 x 4323 (5 x 5 ml) 4124 E Eluting Reagent 5 x 4124 (5 x 25 ml) 4125 S Stabilising Reagent 5 x 4125 (5 x 8 ml) FK641 Sample vials, clear glass, 4ml 1 x FK641 (1 x 1 pcs.) Manual Quick Reference Start Accessories: 43 Analytical Column with test chromatogram Accessories: FK63 Reagent tube (1 x 16 mm) with screw cap and o-ring, PP, autoclavable up to 121 C 5 pcs. HPLC Analysis: Elute with 2.5 ml Eluting Reagent E (receiver vial: 8 μl Stabilising Reagent S) collect the eluate ClinChek Controls: 882 Urine Control, lyophil., Level I 1 x 8 ml 8821 Urine Control, lyophil., Level II 1 x 8 ml 8822 Urine Control, lyophil., Level I, II 2 x 5 x 8 ml Inject 2 μl 37

21 Serotonin is a neurotransmitter in the central nervous system. Serotonin deficiencies are connected with disorders such as depression, schizophrenia, and Parkinson's disease. Moreover, serotonin is produced in excess by carcinoid tumors. Here, the determination of serotonin, together with its metabolite 5-HIAA (see pages 42-47), is used to confirm or rule out the tumor. The RECIPE test kit allows for a quick and sensitive determination of serotonin from platelet-rich plasma, platelet-poor plasma, and serum. For the determination from urine an additional test kit is available (see pages 4-41). Biogenic Amines Serotonin in Plasma Test Data Linearity: 1-1 μg/l Recovery: 8-9 % LLOD:.5 μg/l LLOQ: 1 μg/l Intraassay precision: 3 % Interassay precision: 4 % ClinChek Plasma Control, Level I Serotonin: 5.56 min, IS: 7.13 min ClinChek Plasma Control, Level II Serotonin: 5.56 min, IS: 7.13 min Diagnostics HPLC Parameters Pump: isocratic pump, flow rate: 1. ml/min Injection volume: 2 μl Injection interval: 1 min EC-Detector: potential: 45 mv, sensitivity: 2 na HPLC-Thermostat: 3 C Sample Preparation Precipitation: 2 μl plasma 1 μl Internal Standard IS 1. add 2 μl Precipitant P HPLC Analysis: 2. centrifuge 6 ClinRep Complete Kit for Serotonin in Plasma for 1 assays Kit components (order no. 6): 671 Mobile Phase 1 ml 6711 Standard Solution, lyophil. 5 x 2 ml 6712 IS Internal Standard, lyophil. 5 x 1 ml 613 Plasma Calibrator, lyophil. 5 ml 62 Sample Preparation Vials 1 pcs. 621 P Precipitant 22 ml Manual Quick Reference Start Accessories: 63 Analytical Column with test chromatogram ClinChek Controls: 881 Plasma Control, lyophil., Level I 1 x 5 ml 8811 Plasma Control, lyophil., Level II 1 x 5 ml 889 Plasma Control, lyophil., Level I, II 2 x 5 x 5 ml Inject 2 μl Quick sample preparation Injection interval: 1 min High analytical sensitivity 39

22 Serotonin is an important neurotransmitter. The main metabolite of serotonin is 5-hydroxyindole acetic acid (5-HIAA) which is excreted with urine. Patients with carcinoid tumors usually show increased levels of serotonin in plasma and urine as well as of 5-HIAA in urine (see pages 42-47). As some tumors show a decreased serotonin turn - over (e.g. AADC-deficient tumors), low 5-HIAA levels must be verified by the determination of serotonin. The test kit of RECIPE provides a highly selective sample preparation and guarantees a reliable chromatography. Biogenic Amines Serotonin in Urine Test Data Linearity: 5-1 μg/l Recovery: 7-85 % LLOD: 3 μg/l LLOQ: 5 μg/l Intraassay precision: 3 % Interassay precision: 4 % ClinChek Urine Control, Level I Serotonin: 4.13 min, IS: 5.31 min ClinChek Urine Control, Level II Serotonin: 4.11 min, IS: 5.31 min Diagnostics HPLC Parameters Pump: isocratic pump, flow rate: 1. ml/min Injection volume: 2 μl Injection interval: 1 min EC-Detector: potential: 45 mv, sensitivity: 5 na HPLC-Thermostat: 3 C Sample Preparation Dilution: Extraction: Elution: 2 ml urine 4 ml Stabilising Reagent S Apply the whole sample on the sample preparation column 5 μl Internal Standard IS adjust ph to wash (HPLC water and Washing Solution W) 7 ClinRep Complete Kit for Serotonin in Urine for 1 assays Kit components (order no. 7): 671 Mobile Phase 1 ml 6711 Standard Solution, lyophil. 5 x 2 ml 6712 IS Internal Standard, lyophil. 5 x 1 ml 713 Urine Calibrator, lyophil. 5 x 8 ml 72 Sample Preparation Columns 2 x 72 (2 x 5 pcs.) 721 S Stabilising Reagent 2 x 721 (2 x 2 ml) 722 W Washing Solution 2 ml 723 E Eluting Reagent 5 ml Manual Quick Reference Start Accessories: 73 Analytical Column with test chromatogram Accessories: FK4 Column Rack (for 2 columns) ClinChek Controls: 882 Urine Control, lyophil., Level I 1 x 8 ml 8821 Urine Control, lyophil., Level II 1 x 8 ml 8822 Urine Control, lyophil., Level I, II 2 x 5 x 8 ml Apply 5 ml Eluting Reagent E Highly selective sample clean up HPLC Analysis: Inject 2 μl collect the eluate Reliable chromatography Injection interval: 1 min 41

23 Vanillylmandelic acid (VMA) and homovanillic acid (HVA) are end-products of the catecholamine meta - bolism. The determination of VMA and HVA in urine serves as a screening test for neuroblastoma, one of the most common solid tumors in early childhood. 5-hydroxyindoleacetic acid (5-HIAA) is a metabolite of serotonin and is used for the diagnosis of carcinoid tumors (see pages 38-41). This ClinRep Complete Kit from RECIPE allows a reliable deter - mination of VMA, HVA and 5-HIAA in only 15 min time for analysis. Also available: Complete kits for automated sample preparation (see pages 44-47). Biogenic Amines VMA, HVA and 5-HIAA in Urine Test Data Linearity: VMA:.6-1 mg/l HVA:.3-1 mg/l 5-HIAA:.2-5 mg/l Recovery: 75-9 % LLOD: VMA:.2 mg/l HVA:.1 mg/l 5-HIAA:.1 mg/l LLOQ: VMA:.6 mg/l HVA:.3 mg/l 5-HIAA:.2 mg/l Precision Intraassay: 2.6 % (VMA), 2.5 % (HVA), 3. % (5-HIAA) Interassay: 3.7 % (VMA), 3.8 % (HVA), 3.6 % (5-HIAA) HPLC Parameters Isocratic Pump: flow rate:.9 ml/min Injection vol. / int.: 2 μl / 15 min EC-Detector: pot.: 8 mv, sen.: 5 na HPLC-Thermostat: 3 C ClinChek Urine Control, Level I VMA: 3.67 min, IS: 5.5 min, HVA: 7.99 min, 5-HIAA: 11.8 min ClinChek Urine Control, Level II VMA: 3.62 min, IS: 5.46 min, HVA: 7.96 min, 5-HIAA: min 3 ClinRep Complete Kit for VMA, HVA, 5-HIAA in Urine for 1 assays Kit components (order no. 3): 31 Mobile Phase 1 ml 311 Standard Solution, lyophil. 5 x 1 ml 312 IS Internal Standard, lyophil. 1 ml 313 Urine Calibrator, lyophil. 5 x 5 ml 32 Sample Preparation Columns 2 x 32 (2 x 5 pcs.) 321 A Ammonia Solution 1 ml 322 B Boric Acid Solution 2 x 322 (2 x 3 ml) 323 E Eluting Reagent 2 x 323 (2 x 1 ml) Manual Quick Reference Start Accessories: 33 Analytical Column with test chromatogram Refill Service: 331 Analytical Column with test chromatogram (original column needs to be returned) Diagnostics Sample Preparation Addition of IS: 5 μl urine 1 ml Internal Standard IS ClinChek Controls: 882 Urine Control, lyophil., Level I 1 x 8 ml 8821 Urine Control, lyophil., Level II 1 x 8 ml 8822 Urine Control, lyophil., Level I, II 2 x 5 x 8 ml Highly selective sample preparation Extraction: Apply the whole sample on the sample preparation column Injection interval: 15 min 1. wash with 1 ml Ammonia Solution A Elution: Apply 2 ml Eluting Reagent E 2. fill up with Boric Acid B Reliable test procedure HPLC Analysis: Inject 2 μl collect the eluate 43

24 As an alternative to the determination with manual sample preparation (see pages 42-43), RECIPE offers appropriate ClinRep Complete Kits for use with auto matic pipetting systems from HTA (see pages 46-47) and Gilson. Both instruments allow for an automated preparation and injection of the samples. Biogenic Amines VMA, HVA and 5-HIAA in Urine with Gilson ASPEC XL ClinChek Urine Control, Level I ClinChek Urine Control, Level II Diagnostics Automated sample preparation Test kits available for 1 or 5 assays Injection interval: 15 min Test Data Linearity: VMA:.6-1 mg/l HVA:.3-1 mg/l 5-HIAA:.2-5 mg/l Recovery: 75-9 % LLOD: VMA:.2 mg/l HVA:.1 mg/l 5-HIAA:.1 mg/l LLOQ: VMA:.6 mg/l HVA:.3 mg/l 5-HIAA:.2 mg/l Precision Intraassay: 1.4 % (VMA), 1.9 % (HVA), 2.3 % (5-HIAA) Interassay: 1.8 % (VMA), 2.6 % (HVA), 2.6 % (5-HIAA) HPLC Parameters Isocratic Pump: flow rate:.9 ml/min Injection vol. / int.: 2 μl / 15 min EC-Detector: pot.: 8 mv, sen.: 5 na HPLC-Thermostat: 3 C Sample Preparation Automated sample preparation with Gilson ASPEC XL Addition of IS: Extraction: Apply 1 ml sample on the sample preparation column 1. wash with 1 ml Ammonia Solution A Elution: HPLC Analysis: 5 μl urine 1 ml Internal Standard IS Apply 2 ml Eluting Reagent E 2. wash with 2.5 ml Boric Acid B VMA: 3.67 min, IS: 5.5 min, HVA: 7.99 min, 5-HIAA: 11.8 min VMA: 3.62 min, IS: 5.46 min, HVA: 7.96 min, 5-HIAA: min 31 ClinRep Complete Kit for VMA, HVA, 5-HIAA in Urine for 1 assays (Automated Sample Preparation with Gilson ASPEC XL) Kit components (order no. 31): 31 Mobile Phase 1 ml 311 Standard Solution, lyophil. 5 x 1 ml 312 IS Internal Standard 1 ml 313 Urine Calibrator, lyophil. 5 x 5 ml 312 Sample Preparation Columns 2 x 312 (2 x 5 pcs.) 321 A Ammonia Solution 1 ml 322 B Boric Acid Solution 2 x 322 (2 x 3 ml) 323 E Eluting Reagent 2 x 323 (2 x 1 ml) Manual Quick Reference 32 ClinRep Complete Kit for VMA, HVA, 5-HIAA in Urine for 5 assays (Automated Sample Preparation with Gilson ASPEC XL) Kit components (order no. 32): 31 Mobile Phase 5 x 31 (5 x 1 ml) 311 Standard Solution, lyophil. 5 x 311 (5 x 5 x 1 ml) 312 IS Internal Standard 5 x 312 (5 x 1 ml) 313 Urine Calibrator, lyophil. 5 x 313 (5 x 5 x 5 ml) 312 Sample Preparation Columns 1 x 312 (1 x 5 pcs.) 321 A Ammonia Solution 5 x 321 (5 x 1 ml) 322 B Boric Acid Solution 1 x 322 (1 x 3 ml) 323 E Eluting Reagent 1 x 323 (1 x 1 ml) Manual Quick Reference Start Accessories: 33 Analytical Column with test chromatogram Refill Service: 331 Analytical Column with test chromatogram (original column needs to be returned) ClinChek Controls: 882 Urine Control, lyophil., Level I 1 x 8 ml 8821 Urine Control, lyophil., Level II 1 x 8 ml 8822 Urine Control, lyophil., Level I, II 2 x 5 x 8 ml Inject 2 μl 45

25 As an alternative to the determination with manual sam ple preparation (see pages 42-43), RECIPE offers appropriate ClinRep Complete Kits for use with auto matic pipetting systems from Gilson (see pages 44-45) and HTA. Both instruments allow for an automated preparation and injection of the samples. Biogenic Amines VMA, HVA and 5-HIAA in Urine with HTA, Model HT4E ClinChek Urine Control, Level I ClinChek Urine Control, Level II Diagnostics Automated sample preparation Test kits available for 1 or 5 assays Injection interval: 15 min Test Data Linearity: VMA:.9-5 mg/l HVA:.9-5 mg/l 5-HIAA:.5-25 mg/l Recovery: 75-9 % LLOD: VMA:.3 mg/l HVA:.3 mg/l 5-HIAA:.2 mg/l LLOQ: VMA:.9 mg/l HVA:.9 mg/l 5-HIAA:.5 mg/l Precision Intraassay: 2.5 % (VMA), 3.2 % (HVA), 2.8 % (5-HIAA) Interassay: 2.2 % (VMA), 2.6 % (HVA), 2.3 % (5-HIAA) HPLC Parameters Isocratic Pump: flow rate:.9 ml/min Injection vol. / int.: 2 μl / 15 min EC-Detector: pot.: 8 mv, sen.: 1 na HPLC-Thermostat: 3 C Sample Preparation Automated sample preparation with HT4E Addition of IS: Extraction: Apply 1 ml sample on the sample preparation column 1. wash with 1 ml Ammonia Solution A Elution: HPLC Analysis: 1 μl urine 9 μl Internal Standard IS Apply 2 ml Eluting Reagent E Inject 2 μl 2. wash with 2.5 ml Boric Acid B VMA: 3.67 min, IS: 5.5 min, HVA: 7.99 min, 5-HIAA: 11.8 min VMA: 3.62 min, IS: 5.46 min, HVA: 7.96 min, 5-HIAA: min 33 ClinRep Complete Kit for VMA, HVA, 5-HIAA in Urine for 1 assays (Automated Sample Preparation with HT4E) Kit components (order no. 33): 31 Mobile Phase 1 ml 311 Standard Solution, lyophil. 5 x 1 ml 312 IS Internal Standard 1 ml 313 Urine Calibrator, lyophil. 5 x 5 ml 332 Sample Preparation Columns 2 x 332 (2 x 5 pcs.) 321 A Ammonia Solution 1 ml 322 B Boric Acid Solution 2 x 322 (2 x 3 ml) 323 E Eluting Reagent 2 x 323 (2 x 1 ml) FK641 Sample vials, clear glass, 4ml 2 x FK641 (2 x 1 pcs.) FK642 Sample vial without cap, PP, 1.5 ml 1 pcs. Manual Quick Reference 34 ClinRep Complete Kit for VMA, HVA, 5-HIAA in Urine for 5 assays (Automated Sample Preparation with HT4E) Kit components (order no. 34): 31 Mobile Phase 5 x 31 (5 x 1 ml) 311 Standard Solution, lyophil. 5 x 311 (5 x 5 x 1 ml) 312 IS Internal Standard 5 x 312 (5 x 1 ml) 313 Urine Calibrator, lyophil. 5 x 313 (5 x 5 x 5 ml) 332 Sample Preparation Columns 1 x 332 (1 x 5 pcs.) 321 A Ammonia Solution 5 x 321 (5 x 1 ml) 322 B Boric Acid Solution 1 x 322 (1 x 3 ml) 323 E Eluting Reagent 1 x 323 (1 x 1 ml) FK641 Sample vials, clear glass, 4ml 1 x FK641 (1 x 1 pcs.) FK642 Sample vial without cap, PP, 1.5 ml 5 x FK642 (5 x 1 pcs.) Manual Quick Reference Start Accessories: 33 Analytical Column with test chromatogram Refill Service: 331 Analytical Column with test chromatogram (original column needs to be returned) ClinChek Controls: 882 Urine Control, lyophil., Level I 1 x 8 ml 8821 Urine Control, lyophil., Level II 1 x 8 ml 8822 Urine Control, lyophil., Level I, II 2 x 5 x 8 ml

26 Diabetes mellitus is a chronic disease which is associated with abnormally high blood glucose levels. The determination of HbA1c is an important diagnostic tool for monitoring the efficiency of dietary control and therapy during treatment of diabetes mellitus. Due to the excellent specificity and reproducibility, HPLC is still considered as the gold standard method for the adjustment of the blood glucose con - centration in diabetes patients. The HbA1c values, obtained with this method, are in accordance with the value level of the DCCT and are traceable to the IFCC reference system. The kit can be applied to the analyser Diamat TM or any conventional mo du - lar HPLC system. Diabetes, Hemoglobin Testing Hemoglobin A1c (HbA1c) in Whole Blood (for Diamat TM and Modular HPLC) Test Data Linearity: The test is linear over the whole range of phy sio lo gi cally occurring HbA1c values (approx % HbA1c). Intraassay precision: 1-2 % Interassay precision: 2-3 % ClinChek Hemolysate Control, Level I Intensity 1% HbA1a: 1.1 min, HbA1b: 1.6 min, HbF: 2.1 min, HbA1c: 2.8 min, HbA: 4. min ClinChek Hemolysate Control, Level II HbA1a: 1.1 min, HbA1b: 1.6 min, HbA1c: 2.7 min, HbA: 4. min 11 ClinRep Complete Kit for Hb A1c in Whole Blood for 1 assays Intensity 1% Diagnostics Dependence on the amount of total hemoglobin: The HbA1c value is independent on the amount of total hemoglobin in a range from 6-24 g/dl total hemoglobin. Components of the Complete Kit (order no. 11): 111 ClinRep Reagent Kit 1111 Reference Standard 1 x 5 ml 113 Analytical Column with test chromatogram Manual Quick Reference Reliable and cost-efficient analysis Gold standard for HbA1c analysis Column lifetime: > 1 analyses HPLC Parameters for Modular HPLC Systems / for Diamat TM Pump: Ternary Gradient Pump / Ternary Gradient Pump Flow rate: 1.5 ml/min / 1.1, 1.5 or 1.8 ml/min Injection volume: Injection interval: UV/VIS-Detector: 2 μl / 2 μl 5 min / 8-, 5- or 3 min programme 415 nm / 415 nm HPLC-Thermostat: 23 C / 23 C Sample Preparation A: Venous Blood Hemolysis: 5 μl venous blood 1.25 ml Hemolysis Reagent H HPLC Analysis: B: Capillary Blood Hemolysis: Inject 2 μl incubate (3 min, 37 C) 5 μl capillary blood vial with Hemolysis Reagent H HPLC Analysis: incubate (24 h, ambient temperature) Components of the Reagent Kit (order no. 111): 117 Buffer 1 2 x 117 (2 x 24 ml) 118 Buffer 2 24 ml 119 Buffer 3 2 x 119 (2 x 21 ml) 1113 H Hemolysis Reagent 13 ml 1114 W Washing Solution 21 ml Refill Service: 1131 Analytical Column (refill) with test chromatogram (original column needs to be returned) Accessories: 112 ClinRep Sample Preparation Kit for Capillary Blood (for 5 assays) 1 set containing: 5 Sample vials with 1 ml hemolysis reagent each, 1 Capillary holder 1 Capillary dispenser with 5 heparinised capillaries à 5 μl Sample vials with 1 ml of hemolysis reagent each 2 sets 1122 Capillary dispenser, cont. 5 heparinised capillaries à 5 μl 2 pcs Capillary holder 2 pcs Sample vials 1.5 ml without cap 1 pcs Hemolysis Reagent esp. for capillary blood sampling (heavy metal free) 2 ml 1127 Sample vials 1.5 ml with purple cap 1 pcs Printerpaper 1 rolls FK3 Thermocult Incubator (37 C) FK581 PEEK tubing (connection of prefilter and column) FK582 Stainless steel prefilter holder FK5821 Replacement filter for stainless steel prefilter holder 1 pcs. ClinChek Controls: 118 Hemolysate Control, Level I, ready for use 1 x 5 ml 1181 Hemolysate Control, Level II, ready for use 1 x 5 ml 1182 Hemolysate Control, Level I, II, ready for use 2 x 5 x 5 ml Inject 2 μl DIAMAT TM is a registered trademark of BioRad 49

27 This RECIPE HbA1c test kit is designed for the appli cation with the analyser Variant TM. However, the kit can also be used with any conventional modular HPLC system. Diabetes, Hemoglobin Testing Hemoglobin A1c (HbA1c) in Whole Blood (for Variant TM and Modular HPLC) ClinChek Hemolysate Control, Level I Intensity 2% ClinChek Hemolysate Control, Level II Intensity 2% Diagnostics Reliable and cost-efficient analysis Gold standard for HbA1c analysis Test Data Linearity: The test is linear over the whole range of phy sio lo gi cally occurring HbA1c values (approx % HbA1c). Intraassay precision: 1-2 % Interassay precision: 2-3 % Dependence on the amount of total hemoglobin: The HbA1c value is independent on the amount of total hemoglobin in a range from 6-24 g/dl total hemoglobin. HPLC Parameters Pump: binary gradient pump Flow rate: 2. ml/min Injection volume: 2 μl Injection interval: 3 min UV/VIS-Detector: 415 nm HPLC-Thermostat: 23 C Sample Preparation A: Venous Blood Hemolysis: 5 μl venous blood 1.25 ml Hemolysis Reagent H HPLC Analysis: incubate (3 min, 37 C) Inject 2 μl B: Capillary Blood Hemolysis: 5 μl capillary blood vial with Hemolysis Reagent H HbA1a:.4 min, HbA1b:.55 min, HbF:.75 min, HbA1c: 1.7 min, HbA: 1.61 min HbA1a:.39 min, HbA1b:.55 min, HbF:.76 min, HbA1c: 1.3 min, HbA: 1.61 min 111 ClinRep Complete Kit for Hb A1c in Whole Blood for 1 assays Components of the Complete Kit (order no. 111): 1111 ClinRep Reagent Kit 1111 Reference Standard 1 x 5 ml 1113 Analytical Column with test chromatogram Manual Quick Reference Components of the Reagent Kit (order no. 1111): 1117 Buffer 1 2 x 1117 (2 x 24 ml) 1118 Buffer 2 2 x 1118 (2 x 24 ml) 1113 H Hemolysis Reagent 13 ml 1114 W Washing Solution 21 ml Accessories: 112 ClinRep Sample Preparation Kit for Capillary Blood (for 5 assays) 1 set containing: 5 Sample vials with 1 ml hemolysis reagent each, 1 Capillary holder 1 Capillary dispenser with 5 heparinised capillaries à 5 μl Sample vials with 1 ml of hemolysis reagent each 2 sets 1122 Capillary dispenser, cont. 5 heparinised capillaries à 5 μl 2 pcs Capillary holder 2 pcs Sample vials 1.5 ml without cap 1 pcs Hemolysis Reagent esp. for capillary blood sampling (heavy metal free) 2 ml 1127 Sample vials 1.5 ml with purple cap 1 pcs Printerpaper 1 rolls FK3 Thermocult Incubator (37 C) FK581 PEEK tubing (connection of prefilter and column) FK582 Stainless steel prefilter holder FK5821 Replacement filter for stainless steel prefilter holder 1 pcs. ClinChek Controls: 118 Hemolysate Control, Level I, ready for use 1 x 5 ml 1181 Hemolysate Control, Level II, ready for use 1 x 5 ml 1182 Hemolysate Control, Level I, II, ready for use 2 x 5 x 5 ml Column lifetime: > 1 analyses HPLC Analysis: Inject 2 μl incubate (24 h, ambient temperature) VARIANT TM is a registerd trademark of BioRad 51

28 Defects in genes, which are responsible for the syn - the sis of the hemoglobin molecule, result in a group of hereditary diseases termed as hemo glo bino - pathies. Depending on the molecular defect, hemo - globinopathies may be classified in structural he - mo glo bin variants and in thalassemias. This test kit allows for a reliable separation and identification of the common and clinically significant hemoglobin variants. For ß-thalassemia screening the kit ensures an exact quan tification of HbF and HbA2. A readyto-use test solution (containing: HbA1c, HbF, HbA, HbE, HbA2, HbD, HbS, HbC), a hemolysate calibra - tor (containing: HbF, HbA2) as well as he mo lysate controls in two levels of concentration are available for quality assurance. Diabetes, Hemoglobin Testing Hemoglobin Variants and β-thalassemia Screening in Whole Blood Test Data Intraassay precision: % (HbF) % (HbA2) Interassay precision: % (HbF) (HbA2) ClinCal Hemolysate Calibrator (HbF/A2) HbA1c: 1.59 min, HbF: 2.3 min, HbA: 3.74 min, HbA2: 4.71 min ClinCheck Hemolysate Control (HbF/A2/S), Level I HbA1c: 1.58 min, HbF: 2.1 min, HbA: 3.72 min, HbA2: 4.71, HbS: 5.52 min Diagnostics Dependence on total hemoglobin: The HbF and HbA2 values are independent on the amount of total hemoglobin in a range from 6-24 g/dl total hemoglobin. HPLC Parameters Pump: binary gradient pump Flow rate: 1.2 ml/min Injection volume: 2 μl Injection interval: 8 min UV/VIS-Detector: 415 nm HPLC-Thermostat: 23 C 131 ClinRep Complete Kit for Hemoglobin Variants and ß-Thalassemia Screening in Whole Blood for 5 assays Components of the Complete Kit (order no. 131): 1311 ClinRep Reagent Kit Hemolysate Calibrator HbF/A2, ready for use 5 x 3 ml 1313 Analytical Column with test chromatogram Manual Quick Reference Components of the Reagent Kit (order no. 1311): 1317 Buffer 1 25 ml 1318 Buffer 2 25 ml 1319 W Washing Solution 2 ml H Hemolysis Reagent 5 ml Optional Components: Test Solution (HbA1c/F/A/E/A2/D/S/C), ready for use 5 x 3 ml Sample Preparation Hemolysis: 5 μl venous blood 1 ml Hemolysis Reagent H Accessories: 1124 Sample vials 1.5 ml without cap 1 pcs. FK581 PEEK tubing (connection of prefilter and column) FK582 Stainless steel prefilter holder FK5821 Replacement filter for stainless steel prefilter holder 1 pcs. Reliable separation and quantification of HbA2 and HbF HPLC Analysis: Inject 2 μl incubate (1 min, ambient temp.) ClinChek Controls: Hemolysate Control HbF/A2, Level I, II, ready for use 2 x 5 x 3 ml Hemolysate Control HbF/A2/S, Level I, ready for use 5 x 3 ml Safe identification of HbS, HbC, HbE and HbD Test solution, calibrator and control materials available 53

29 5-Aminolevulinic acid (5-ALA) and porphobilinogen (PBG) are intermediates in the biosynthesis of heme and hemoglobin. In certain diseases, so-called por - phyrias, an accumulation of 5-ALA and PBG is observed due to abnormalities in the heme produc - tion. Porphyrias may be genetically predetermined (hereditary porphyrias), or may be induced by diffe - rent external factors, mostly by lead intoxica tion. Metabolic Diseases 5-Aminolevulinic Acid / Porphobilinogen in Urine Diagnostics Test Data Linearity:.8-8 mg/l Recovery: > 9 % LLOD:.6 mg/l LLOQ:.8 mg/l Intraassay precision: 5-ALA: 3.4 % PBG: 5.2 % Interassay precision: 5-ALA: 4.6 % PBG: 6.4 % Sample Preparation Extraction: Apply.5 ml urine to a conditioned 5-ALA / PBG double column Cost-efficient quick test Easy handling Reliable test results A: Sample Preparation for 5-ALA Elution: Elute with 7. ml Reagent A (receiver tube: 5 μl Reagent B) Derivatisation: Analysis: Elution: Analysis: collect the eluate 1. Incubate at 1 C (water bath, 1 min) 2. Add 7. ml Ehrlichʼs Reagent 3. Incubate at room temperature (15 min) Photometric measurement B: Sample Preparation for PBG Derivatisation: Elute with 4. ml Reagent D collect the eluate 1. Add 4. ml Ehrlichʼs Reagent 2. Incubate at room temperature (15 min) Photometric measurement wash (3 x 1 ml HPLC water) Separate the double column Colourless column: A: Sample Preparation for 5-ALA Blue column: B: Sample Preparation for PBG 172 ClinRep Complete Kit for 5-Aminolevulinic Acid and Porphobilinogen in Urine for 5 assays Kit Components (order no 172): 1722 Sample Preparation Columns for 5-ALA 5 pcs Sample Preparation Columns for PBG 5 pcs Reagent A 5 ml Reagent B 5 ml Reagent C 2 x (2 x 7.5 g) Reagent D 2 ml Manual Quick Reference 173 ClinRep Complete Kit for Porphobilinogen in Urine for 5 assays Kit Components (order no 173): 1732 Sample Preparation Columns for PBG 5 pcs Reagent C 7.5 g Reagent D 2 ml Manual Quick Reference Accessories: 1726 Column Rack (for 2 columns) FK63 Reagent tube (1 x 16 mm) with screw cap and o-ring, PP, autoclavable up to 121 C 5 pcs. ClinCal Calibrator: Urine Calibrator, lyophil. 5 x 5 ml ClinChek Controls: 1728 Urine Control, lyophil., Level I 1 x 5 ml Urine Control, lyophil., Level II 1 x 5 ml Urine Control, lyophil., Level I, II 2 x 5 x 5 ml 55

30 Homocysteine is an established marker to estimate the risk towards atherosclerosis and coronary heart disease. An elevated plasma homocysteine level (hyperhomocysteinemia), whether due to nutrient deficiencies or by genetic defects, can be reduced by intake of folic acid, vitamin B6 and B12. There - fore, the determination of homocysteine does not only serve for the risk assessment towards atherosclerotic affections but also to ensure the proper combination and dosage of a nutrition supplement therapy. The RECIPE test kit allows for the simultaneous analysis of total homocysteine (thcys) and total cysteine (tcys). Metabolic Diseases Homocysteine in Plasma Test Data Linearity: 1-1 μmol/l Recovery: % LLOD:.5 μmol/l LLOQ: 1 μmol/l Intraassay precision: 3.9 % Interassay precision: 5.8 % ClinChek Plasma Control, Level I Cysteine: 2.1 min, IS: 2.47 min, Cysteinylglycine: 2.85 min, Homocysteine: 3.31 min ClinChek Plasma Control, Level II Cysteine: 2.11 min, IS: 2.48 min, Cysteinylglycine: 2.85 min, Homocysteine: 3.31 min Diagnostics HPLC Parameters Pump: isocratic pump, flow rate: 1. ml/min Injection volume: 2 μl Injection interval: 5 min Fluorescence detector: 385 nm (exc.), 515 nm (em.) HPLC-Thermostat: 3 C Sample Preparation Reduction: 23 ClinRep Complete Kit for Homocysteine in Plasma for 1 assays Kit Components (order no. 23): 231 Mobile Phase 1 ml 2311 Standard Solution 3 ml 2312 IS Internal Standard 3 ml 2313 Plasma Calibrator, lyophil. 3 ml 232 Sample Preparation Vials 1 pcs Reagent A 3 ml 2322 Reagent B 1 ml 2323 Reagent C 1 ml 2324 Reagent D 5 ml Manual Quick Reference 1 μl plasma 25 μl Internal Standard IS 25 μl Reagent A Start Accessories: 233 Analytical Column with test chromatogram Reliable sample preparation (specific derivatisation reagent) Precipitation: 15 μl reduced sample Derivatisation: centrifuge 5 μl supernatant 1 μl Reagent C 5 μl Reagent D HPLC Analysis: Inject 2 μl 1 μl Reagent B incubate (6 min, 6 C) Accessories: μl derivatisation vial with cap (PE) 5 pcs. FK581 PEEK tubing (connection of prefilter and column) FK582 Stainless steel prefilter holder FK5821 Replacement filter for stainless steel prefilter holder 1 pcs. ClinChek Controls: 238 Plasma Control, lyophil., Level I 1 x 3 ml 2381 Plasma Control, lyophil., Level II 1 x 3 ml 2382 Plasma Control, lyophil., Level I, II 2 x 5 x 3 ml Injection interval: 5 min 57

31 Osteoporosis is a metabolic bone disease which is characterised by an abnormally low bone density and therefore is associated with an increased risk of fracture. The bone degradation goes along with an increased formation of the amino acid hydroxypro - line, which is released into blood circulation and is excreted with urine. The RECIPE test kit guaran tees an accurate hydroxyproline measurement. Using a special sample preparation, hydroxyproline is turned into a derivative and can be quantified without inter - ferences from other amino acids. Metabolic Diseases Hydroxyproline in Urine Test Data Linearity: 5-17 mg/l Recovery: 9-1 % LLOD: 3 mg/l LLOQ: 5 mg/l Intraassay precision: 3.5 % Interassay precision: 4.5 % ClinChek Urine Control, Level I Hydroxyproline: 3.2 min, IS: 5.1 min 5.1 ClinChek Urine Control, Level II Hydroxyproline: 3.2 min, IS: 5.1 min 5.1 Diagnostics High analytical selectivity Injection interval: 8 min HPLC Parameters Pump: binary gradient pump, flow rates: 1.2, 1.4 ml/min Injection volume: 2 μl Injection interval: 8 min UV/VIS-Detector: 471 nm HPLC-Thermostat: 6 C Sample Preparation Hydrolysis: 1 ml urine Derivatisation: 1 μl Internal Standard IS 1 ml HCl incubate (16 h, 95 C) 1. 1 μl sample + 3 μl Reagent A + 8 μl Reagent B / C 2. 5 μl sample + 2 μl Reagent D μl sample + 2 μl Reagent E Dilution: Complete sample HPLC Analysis: Inject 2 μl incubate (1 min, 7 C) 5 μl Mobile Phase A 16 ClinRep Complete Kit for Hydroxyproline in Urine for 1 assays Kit Components (order no 16): 168 Mobile Phase A 1 ml 169 Mobile Phase B 15 ml 1611 Standard Solution 5 ml 1612 IS Internal Standard 1 ml 1613 Urine Calibrator, lyophil. 5 x 8 ml 162 Hydrolysis Tubes with caps 1 pcs ph - Test Stripes 1 pcs Reagent A 3 ml 1623 Reagent B 8 ml 1624 Reagent C 8 ml 1625 Reagent D 2 x 1625 (2 x 5 mg) 1626 Reagent E 2 ml Manual Quick Reference Start Accessories: 163 Analytical Column with test chromatogram Refill Service: 1631 Analytical Column with test chromatogram (original column needs to be returned) Accessories: FK581 PEEK tubing (connection of prefilter and column) FK582 Stainless steel prefilter holder FK5821 Replacement filter for stainless steel prefilter holder 1 pcs. ClinChek Controls: 882 Urine Control, lyophil., Level I 1 x 8 ml 8821 Urine Control, lyophil., Level II 1 x 8 ml 8822 Urine Control, lyophil., Level I, II 2 x 5 x 8 ml Reliable determination 59

32 The porphyrin excretion profile is used for the diagnosis of porphyrias. This ClinRep Complete Kit allows for a separation (differentiation) of the uri - nary porphyrins with high resolution (in different porhyrin-isomers!) and ensures an exact quantification. For sample pretreatment, the samples simply have to be spiked with an internal standard and centrifuged. As quick tests for the screening of por phyrias a column test for the determination of the total porphyrins (see pages 62-63) as well as a column test for the determination of 5-aminolevulinic acid and porphobilinogen are available (see pages 54-55). Metabolic Diseases Porphyrins Differentiated in Urine Test Data Linearity: 1-5 μg/l LLOD:.5 μg/l LLOQ: 1 μg/l Intraassay precision: 2.3 % Interassay precision: 2.6 % ClinChek Urine Control, Level I Uroporphyrin I: 5.19 min, Heptacarboxyporphyrin I: 6.31 min, Hexacarboxyporphyrins (Iac and Iab Isomer): 7.54 min, Internal Standard IS: 8.86 min, Pentacarboxyporphyrin I: 9.55 min, Coproporphyrin I: min, Coproporphyrin III: min ClinChek Urine Control, Level II Uroporphyrin I: 5.16 min, Heptacarboxyporphyrin I: 6.28 min, Hexacarboxyporphyrins (Iac and Iab Isomer): 7.53 min, Internal Standard IS: 8.86 min, Pentacarboxyporphyrin I: 9.55 min, Coproporphyrin I: min, Coproporphyrin III: min Diagnostics HPLC Parameters Pump: binary gradient pump, flow rate:.7 ml/min Injection volume: 2 μl Injection interval: 2 min Fluorescence detector: 394 nm (exc.), 624 nm (em.) HPLC-Thermostat: 3 C Sample Pretreatment Addition of IS: 5 μl urine (calibrator, control, patient) HPLC Analysis: 5 μl Internal Standard IS centrifuge 17 ClinRep Complete Kit for Porphyrins in Urine for 1 assays Kit Components (order no. 17): 178 Mobile Phase A 2 x 178 (2 x 1 ml) 179 Mobile Phase B 8 ml 1711 Standard Solution 5 ml 1712 IS Internal Standard 5 ml 1713 Urine Calibrator, lyophil. 5 x 5 ml 172 Vials for Sample Pretreatment 1 pcs. Manual Quick Reference Start Accessories: 173 Analytical Column with test chromatogram 1732 Guard Column Holder incl. 1 Guard Column 1733 Guard Column 5 pcs. Inject 2 μl of the supernatant Accessories: FK581 PEEK tubing (connection of prefilter and column) FK582 Stainless steel prefilter holder FK5821 Replacement filter for stainless steel prefilter holder 1 pcs. High resolution of the porphyrin profile ClinChek Controls: 178 Urine Control, lyophil., Level I 1 x 5 ml 1781 Urine Control, lyophil., Level II 1 x 5 ml 1782 Urine Control, lyophil., Level I, II 2 x 5 x 5 ml No interferences High analytical sensitivity 61

33 The determination of the urinary total porphyrins serves for the basic diagnosis of suspected porphyrias. With this quick test (no HPLC method) the porphyrin quantification is performed by photometric measurement. For the analysis of the differentiated porphyrin profile a complete kit for HPLC is provided (see pages 6-61). Metabolic Diseases Total Porphyrins in Urine Diagnostics Test Data Linearity: 2-4 μg/l Recovery: ~ 7 % LLOD: 15 μg/l LLOQ: 2 μg/l Intraassay precision: 5.5 % Interassay precision: 7.2 % Sample Preparation Extraction: Apply 1. ml urine to a conditioned sample preparation column Elution: Analysis: wash (1 ml HPLC water) Elute with 2. ml Eluting Reagent E collect the eluate Photometric measurement 171 ClinRep Complete Kit for Porphyrins in Urine for 5 assays Kit Components (order no. 171): 1712 Sample Preparation Columns 5 pcs E Eluting Reagent 2 ml Manual Quick Reference Accessories: FK4 Column Rack (for 2 columns) ClinChek Controls: 1728 Urine Control, lyophil., Level I 1 x 5 ml Urine Control, lyophil., Level II 1 x 5 ml Urine Control, lyophil., Level I, II 2 x 5 x 5 ml Quick test for total porphyrins Easy handling Low price per test 63

34 β-carotene belongs to the group of the so-called carotenoids. These compounds are part of the anti - oxidant defense system within the human organism and are protecting cells and tissues from oxidative damage (oxidative stress). All-trans-β-carotene is the quantitatively most important carotenoid in our diet, in human blood and tissues. The RECIPE ClinRep Complete Kit for β-carotene provides a unique chromatographical performance. Even the cis-isomers of β-carotene (9-cis-β-Carotene, 13-cisβ-Carotene) are base line separated. Prior to HPLC analysis a simple two-step sample preparation (precipitaton, stabilisation) is required. Oxidative Stress β-carotene in Plasma / Serum Test Data On request HPLC Parameters Pump: isocratic pump, flow rate: 1.1 ml/min Injection volume: 1 μl Injection interval: 1 min UV-Detector: 45 nm HPLC-Thermostat: 3 C Sample Preparation Precipitation: 1 μl sample HPLC Analysis: 2 μl Precipitant P (contains IS) Inject 1 μl mix, centrifuge 1 μl Stabilising Reagent S ClinChek Plasma Control, Level I IS: 3.55 min, α-carotene: 7.79 min, all-trans-ß-carotene: 8.43 min, 9-cis-ß-Carotene: 9.23 min, 13-cis-ß-Carotene: 9.76 min ClinChek Plasma Control, Level II IS: 3.55 min, α-carotene: 7.81 min, all-trans-ß-carotene: 8.43 min, 9-cis-ß-Carotene: 9.23 min, 13-cis-ß-Carotene: 9.76 min 3 ClinRep Complete Kit for ß-Carotene in Plasma / Serum for 1 assays Kit Components (order no. 3): 31 Mobile Phase 1 ml 312 P Precipitant with IS Internal Standard 2 ml 313 Plasma Calibrator, lyophil. 5 x.5 ml 314 Test Solution, lyophil. 3 ml 32 Sample Preparation Vials 1 pcs. 321 S Stabilising Reagent 1 ml Manual Quick Reference Diagnostics Start Accessories: 33 Analytical Column with test chromatogram Accessories: FK581 PEEK tubing (connection of prefilter and column) FK582 Stainless steel prefilter holder FK5821 Replacement filter for stainless steel prefilter holder 1 pcs. Simple two-step sample preparation ClinChek Controls: 38 Plasma Control, lyophil., Level I 1 x 2 ml 381 Plasma Control, lyophil., Level II 1 x 2 ml 382 Plasma Control, lyophil., Level I, II 2 x 5 x 2 ml Excellent chromatographic performance (separation of cis isomers) Injection interval: 1 min 65

35 Coenzyme Q1 (CoQ1) plays an outstanding role in the energy production within the cell metabolism. In addition, CoQ1 is an important antioxidant and thus protects the cell from radical oxidation (oxidative stress). Lowered blood concentrations of CoQ1 seem to be connected with a number of diseases, mainly cardiovascular diseases. The RECIPE ClinRep Complete Kit allows for a reliable de ter - mi nation of CoQ1 in whole blood, plasma, and serum. After a quick sample preparation, the analy - tical chro ma tography is performed with an isocratic HPLC system and UV detection. For quality assurance reference materials (ClinTest Test Solution, ClinCal Plasma Cali bra tor and ClinChek Plasma Controls) with excellent stability are available. Oxidative Stress Coenzyme Q1 in Whole Blood / Plasma / Serum Test Data Linearity: μg/l Recovery: % LLOD: 19.5 μg/l LLOQ: 38.9 μg/l Intraassay precision: 3.4 % Interassay precision: 5. % HPLC Parameters Pump: isocratic pump, flow rate: 1.4 ml/min Injection volume: 3 μl Injection interval: 14 min UV-Detector: 275 nm HPLC-Thermostat: 3 C ClinChek Plasma Control, Level I 1,5 1,,5, IS: 7.34 min, CoQ1: min ClinChek Plasma Control, Level II IS: 7.32 min, CoQ1: min 31 ClinRep Complete Kit for Coenzyme Q1 in Whole Blood / Plasma / Serum for 1 assays Kit Components (order no. 31): 311 Mobile Phase 1 ml 3112 IS Internal Standard 4 ml 3113 Plasma Calibrator, lyophil. 5 x 2 ml 3114 Test Solution 3 ml 312 Sample Preparation Vials 1 pcs P Precipitant 5 ml 3122 O Oxidation Reagent 5 ml Manual Quick Reference 1,5 1,,5, Diagnostics Sample Preparation Precipitation: 5 μl Precipitant P 1. Add 4 μl sample 2. Add 5 μl Oxidation Reagent O Start Accessories: 313 Analytical Column with test chromatogram 3132 Guard Column Holder incl. 1 Guard Column Accessories: 3133 Guard Column 5 pcs. FK581 PEEK tubing (connection of prefilter and column) FK582 Stainless steel prefilter holder FK5821 Replacement filter for stainless steel prefilter holder 1 pcs. Reliable sample preparation HPLC Analysis: mix Add 4 μl Internal Standard IS mix, centrifuge ClinChek Controls: 318 Plasma Control, lyophil., Level I 1 x 2 ml 3181 Plasma Control, lyophil., Level II 1 x 2 ml 3182 Plasma Control, lyophil., Level I, II 2 x 5 x 2 ml Inject 3 μl of the supernatant Reference materials with excellent stability available 67

36 Malondialdehyde is formed by radical mediated lipid peroxidation (oxidative stress) and shows mutage - nic and cytotoxics effects by further reaction with DNA. For this reason, malondialdehyde is considered a suitable biomarker for the determination of oxi - da tive stress. The RECIPE ClinRep Complete Kit allows for the reliable quantification of malondialdehyde from plasma and serum. For quality assurance a ClinCal Plasma Calibrator and ClinChek Plasma Controls in two levels are available. Oxidative Stress Malondialdehyde in Plasma / Serum Test Data Linearity:.4-2 μmol/l Recovery: 1 % LLOD:.2 μmol/l LLOQ:.4 μmol/l Intraassay precision: 3.7 % Interassay precision: 7.4 % ClinChek Plasma Control, Level I ,5 1, 1,5 2, 2,5 3, 3,5 4, 4,5 5, Malondialdehyde: 2.75 min 2.75 ClinChek Plasma Control, Level II Malondialdehyde: 2.75 min ,5 1, 1,5 2, 2,5 3, 3,5 4, 4,5 5, 2.75 Diagnostics HPLC Parameters Pump: isocratic pump, flow rate:.8 ml/min Injection volume: 2 μl Injection interval: 5 min Fluorescence detector: 515 nm (exc.), 553 nm (em.) HPLC-Thermostat: 3 C 32 ClinRep Complete Kit for Malondialdehyde in Plasma / Serum for 1 assays Kit Components (order no. 32): 321 Mobile Phase 1 ml 3213 Plasma Calibrator, lyophil. 5 x.5 ml 322 Derivatisation Vials 1 pcs Sample Preparation Vials 1 pcs Reagent A 7 ml 3223 Reagent B 2 ml 3224 Reagent C 2 ml Manual Quick Reference Sample Preparation Derivatisation: 1 μl sample 7 μl Reagent A 2 μl Reagent B Start Accessories: 323 Analytical Column with test chromatogram 3231 Guard Column 5 pcs. FK7 manu-cart cartridgeholder, one time accessory 1 set Reliable sample preparation Neutralisation / Precipitation: 2 μl sample HPLC Analysis: incubate (6 min, 1 C) centrifuge Inject 2 μl of the supernatant 2 μl Reagent C Accessories: FK581 PEEK tubing (connection of prefilter and column) FK582 Stainless steel prefilter holder FK5821 Replacement filter for stainless steel prefilter holder 1 pcs. ClinChek Controls: 328 Plasma Control, lyophil., Level I 1 x.5 ml 3281 Plasma Control, lyophil., Level II 1 x.5 ml 3282 Plasma Control, lyophil., Level I, II 2 x 5 x.5 ml Robust chromatography Injection interval: 5 min 69

37 Vitamin C (ascorbic acid) is a potential scavenger to radicals and oxidants. The exposure to these spe - cies is termed as oxidative stress. Oxidative stress is believed to contribute to the development of various chronic diseases such as cardiovascular disease, diabetes, and cancer. An inadequate vitamin C status is usually observed in cases of malnutrition, smoking, alcohol abuse, chronic toxications and stress. Also, nursing women and elderly people are in danger of a low vitamin C status. The RECIPE test kit features fast analysis (quick sample preparation, short run time) and ensures reliable results. Oxidative Stress Vitamin C in Plasma Test Data Linearity:.5-3 mg/l Recovery: 95-1 % LLOD:.1 mg/l LLOQ:.5 mg/l Intraassay precision: 5.9 % Interassay precision: 6.9 % ClinChek Serum Control, Level I Vitamin C: 1.79 min, IS: 4.4 min 4.4 ClinChek Serum Control, Level II Vitamin C: 1.79 min, IS: 4.3 min Diagnostics HPLC Parameters Pump: isocratic pump, flow rate: 1.3 ml/min Injection volume: 2 μl Injection interval: 5 min UV-Detector: 243 nm HPLC-Thermostat: 3 C Sample Preparation Precipitation: 1 μl sample 1. incubate (1 min, + 4 C) HPLC Analysis: 1 μl Precipitant P (contains Internal Standard IS) 2. centrifuge Inject 2 μl of the supernatant 28 ClinRep Complete Kit for Vitamin C in Plasma for 1 assays Kit Components (order no. 28): 281 Mobile Phase 1 ml 2812 P Precipitant with Internal Standard IS, lyophil. 5 x 3 ml 2813 Serum Calibrator, lyophil. 5 x.5 ml 2814 Test Solution, lyophil. 5 x 1 ml 2815 R Reconstitution Solution 25 ml 282 Sample Preparation Vials 1 pcs. Manual Quick Reference Start Accessories: 283 Analytical Column with test chromatogram 2832 Guard Column Holder incl. 1 Guard Column Accessories: 2833 Guard Column 5 pcs. FK581 PEEK tubing (connection of prefilter and column) FK582 Stainless steel prefilter holder FK5821 Replacement filter for stainless steel prefilter holder 1 pcs. ClinChek Controls: 288 Serum Control, lyophil., Level I 1 x.5 ml 2881 Serum Control, lyophil., Level II 1 x.5 ml 2882 Serum Control, lyophil., Level I, II 2 x 5 x.5 ml Quick sample preparation Injection interval: 5 min Reference materials with excellent stability available 71

38 Vitamin A (retinol) and vitamin E (α-tocopherol) be - long to the fat soluble class of vitamins. In contrast to water soluble vitamins, an excessive administration may lead to hypervitaminosis. Vitamin A deficiency is the leading cause of preventable blindness in children and raises the risk of disease and death from severe infections. Vitamin E is an important anti oxidant and is thought to have a role in preven - ting atherosclerosis by inhibiting oxidation of lowdensity lipoprotein (LDL). The RECIPE ClinRep Com plete Kit allows for the simultaneous analysis of both vitamins within a run time of 8 min. For quality assurance, reference materials with excellent stability are available. Quick sample preparation Vitamin Status Vitamin A and E in Plasma Test Data Linearity: Vitamin A:.2-5. mg/l, Vitamin E:.4-5 mg/l Recovery: % LLOD: Vitamin A:.1 mg/l, Vitamin E:.3 mg/l LLOQ: Vitamin A:.2 mg/l, Vitamin E:.4 mg/l Intraassay precision: Vitamin A: 1.4 %, Vitamin E: 1.4 % Interassay precision: Vitamin A: 5. %, Vitamin E: 3.2 % HPLC Parameters Pump: isocratic pump, flow rate: 1.5 ml/min Injection volume: 5 μl Injection interval: 8 min UV-Detector: 325 / 295 nm HPLC-Thermostat: 3 C Sample Preparation Extraction: 15 μl plasma / serum Stabilisation: 1 μl supernatant 15 μl Precipitant P (contains Internal Standard IS) centrifuge 1 μl Stabilising Reagent S ClinChek Serum Control, Level I Vitamin A: 1.82 min, IS: 4.91 min, Vitamin E: 7.2 min ClinChek Serum Control, Level II Vitamin A: 1.82 min, IS: 4.91 min, Vitamin E: 7.19 min 22 ClinRep Complete Kit for Vitamin A and E in Plasma for 1 assays Kit components (order no. 22): 221 Mobile Phase 1 ml 2211 Standard Solution 3 ml 2212 P Precipitant with Internal Standard IS 15 ml 2213 Serum Calibrator, lyophil. 3 ml 222 Sample Preparation Vials with Reagent, lyophil. 2 x 222 (2 x 5 pcs.) 2221 Reaction Vials 1 pcs S Stabilising Reagent 1 ml Manual Quick Reference Start Accessories: 223 Analytical Column with test chromatogram FK7 manu-cart cartridgeholder, one time accessory 1 set Accessories: FK581 PEEK tubing (connection of prefilter and column) FK582 Stainless steel prefilter holder FK5821 Replacement filter for stainless steel prefilter holder 1 pcs. ClinChek Controls: 887 Serum Control, lyophil., Level I 1 x 5 ml 8871 Serum Control, lyophil., Level II 1 x 5 ml 8872 Serum Control, lyophil., Level III 1 x 5 ml 8873 Serum Control, lyophil., Level I, II, III 3 x 3 x 5 ml Diagnostics Injection interval: 8 min HPLC Analysis: centrifuge Inject 5 μl of the supernatant Reference materials with excellent stability available 73

39 Vitamin B1 (thiamine, thiamine pyrophosphate (TPP)) acts as coenzyme in the carbohydrate meta - bolism and is essential for the normal functioning of the organism. Deficiency mainly occurs in under - nourished people, alcoholics or in special clinical situations (e.g. hemodialysis). A fully developed deficiency syndrome is called BeriBeri. With this RECIPE test kit, vitamin B1 is determined as TPP. The kit can be combined in a convenient manner with the test kits for vitamin B2 and B6 (see combi kit, pages 8-81). Vitamin Status Vitamin B1 in Whole Blood Test Data Determination as TPP Linearity: 1-2 μg/l Recovery: 95-1 % LLOD:.5 μg/l LLOQ: 1 μg/l Intraassay precision: 2.7 % Interassay precision: 4.2 % ClinChek Whole Blood Control, Level I TPP: 2.52 min, Thiamine: 5.1 min 5.1 ClinChek Whole Blood Control, Level II TPP: 2.52 min, Thiamine: 5.9 min Diagnostics Excellent sensitivity:.5 μg/l HPLC Parameters Pump: isocratic pump, flow rate: 1. ml/min Pump (Reagent N): flow rate:.1 ml/min Injection volume: 5 μl Injection interval: 4 min Fluorescence detector: 376 nm (exc.), 435 nm (em.) HPLC-Thermostat: 35 C Sample Preparation Extraction: 3 μl whole blood 5 μl Reagent A Stabilisation: Oxidation: 1. centrifuge Add 5 μl Reagent S 2. take off 4 μl supernatant 45 μl sample 5 μl Reagent C 1 μl Reagent D HPLC Analysis: add 1 μl Reagent E 24 ClinRep Complete Kit for Vitamin B1 in Whole Blood for 1 assays Kit Components (order no. 24): 241 Mobile Phase 1 ml 2414 Test Solution 3 ml Whole Blood Calibrator, lyophil. 5 x 2 ml 242 Sample Preparation Vials 2 x 242 (2 x 1 pcs.) 2421 Reagent A 5 ml 2423 Reagent C 5 ml 2424 Reagent D 1 ml 2425 Reagent E 1 ml Reagent N 25 ml 2427 Reagent S 5 ml Manual Quick Reference Start Accessories: 273 Analytical Column with test chromatogram 2732 Guard Column Holder incl. 1 Guard Column Accessories: 2733 Guard Column 5 pcs. FK2 ClinLab Peristaltic pump FK21 Replacement tubing for peristaltic pump 2 pcs. FK5121 T-Union (PEEK), 1/16" FK581 PEEK-tubing (connection of prefilter and column) FK582 Stainless steel prefilter holder FK5821 Replacement filter for stainless steel prefilter holder 1 pcs. ClinChek Controls: 8874 Whole Blood Control, lyophil., Level I 1 x 2 ml 8875 Whole Blood Control, lyophil., Level II 1 x 2 ml 8876 Whole Blood Control, lyophil., Level I, II 2 x 5 x 2 ml Injection interval: 4 min Inject 5 μl of the supernatant Combinable with B2 and B6 test kits 75

40 The term vitamin B2 covers three vitamers: riboflavin, flavin mononucleotide (FMN) and flavin adenine dinucleotide (FAD). FMN and FAD are the effective forms of vitamin B2 and are synthesised in vivo from riboflavin by phosphorylation. Vitamin B2 is important for energy production, enzyme functions as well as for the fatty acid and amino acid synthesis. The undersupply with vitamin B2 is mostly attributed to a general malnutrition. It is often seen in persons with risk factors such as alcohol problems, advanced age and extreme dietary habits. The RECIPE test kit features short time for analysis (easy sample preparation, short run time) and can be easily combined with test kits for the vitamins B1 and B6 (see combi kit, pages 8-81). Vitamin Status Vitamin B2 in Whole Blood Test Data Determination as FAD Linearity: 2-5 μg/l Recovery: 95-1 % LLOD: 1 μg/l LLOQ: 2 μg/l Intraassay precision: 3.8 % Interassay precision: 4. % ClinChek Whole Blood Control, Level I Flavin adenine dinucleotide: 2.77 min, Flavin mononucleotide: 5.2 min, Riboflavin: 8.24 min ClinChek Whole Blood Control, Level II Flavin adenine dinucleotide: 2.77 min, Flavin mononucleotide: 5.18 min, Riboflavin: 8.26 min 8.26 Diagnostics HPLC Parameters Pump: isocratic pump, flow rate: 1. ml/min Injection volume: 5 μl Injection interval: 1 min Fluorescence detector: 45 nm (exc.), 53 nm (em.) HPLC-Thermostat: 4 C Sample Preparation 25 ClinRep Complete Kit for Vitamin B2 in Whole Blood for 1 assays Kit Components (order no. 25): 251 Mobile Phase 1 ml 2514 Test Solution, lyophil. 5 x 2 ml 2515 R Reconstitution Solution 1 ml Whole Blood Calibrator, lyophil. 5 x 2 ml 252 Sample Preparation Vials 1 pcs P Precipitant 3 ml 2522 S Stabilising Reagent 5 ml Manual Quick Reference Extraction: 2 μl whole blood 3 μl Precipitation Reagent P Start Accessories: 273 Analytical Column with test chromatogram 2732 Guard Column Holder incl. 1 Guard Column 1. add 5 μl Stabilising Reagent S HPLC Analysis: 2. centrifuge Inject 5 μl of the supernatant Accessories: 2733 Guard Column 5 pcs. FK581 PEEK-tubing (connection of prefilter and column) FK582 Stainless steel prefilter holder FK5821 Replacement filter for stainless steel prefilter holder 1 pcs. Quick sample preparation ClinChek Controls: 8874 Whole Blood Control, lyophil., Level I 1 x 2 ml 8875 Whole Blood Control, lyophil., Level II 1 x 2 ml 8876 Whole Blood Control, lyophil., Level I, II 2 x 5 x 2 ml Injection interval: 1 min Combineable with B1 and B6 test kits 77

41 Vitamin B6 consists of three vitamers: pyridoxine, pyridoxal and pyridoxamine. The metabolically active coenzyme form of vitamin B6 is pyridoxal-5'-phosphate (PLP). Clinical signs of vitamin B6 deficiency are mainly expressed in alterations of the skin, neuro logical disorders, and anemias. In addition to this, a low vitamin B6 status may be responsible for an increase of the homocysteine plasma level (hyper- homocysteinemia, see pages 56-57, and ). The RECIPE ClinRep Complete Kit allows for the de ter mination of the vitamin B6 forms pyridoxal and PLP in plasma and whole blood. The test features high analytical sensitivity and can be easily combined with the test kits for the vitamins B1 and B2 (see combi kit, pages 8-81). Excellent sensitivity:.4 μg/l Quick sample preparation Vitamin Status Vitamin B6 in Plasma / Whole Blood Test Data Determination from plasma / from whole blood Linearity: Pyridoxal:.6-8 μg/l /.6-12 μg/l Pyridoxal-5ʻ-phosphate:.6-8 μg/l /.6-15 μg/l Recovery: 95-1 % / 95-1 % LLOD:.4 μg/l for both analytes and both matrizes LLOQ:.6 μg/l for both analytes and both matrizes Intraassay precision: Pyridoxal: 5.1 % / 8.4 % Pyridoxal-5ʻ-phosphate: 2.5 % / 2.3 % Interassay precision: Pyridoxal: 6.9 % / 9.2 % HPLC Parameters Pump: Pump (Reagent N): Injection volume: Injection interval: Fluorescence detector: Temperature: Sample Preparation Extraction: Pyridoxal-5ʻ-phosphate: 3.1 % / 2.9 % isocratic pump, flow rate: 1. ml/min flow rate:.2 ml/min 5 μl 1 min 37 nm (exc.), 47 nm (em.) 25 C (or ambient) 1 μl sample 1 μl Precipitant P ClinChek Whole Blood Control, Level I Pyridoxal-5ʼ-phosphate: 5.24 min, Pyridoxal: 8.82 min ClinChek Whole Blood Control, Level II Pyridoxal-5ʼ-phosphate: 5.22 min, Pyridoxal: 8.82 min 26 ClinRep Complete Kit for Vitamin B6 in Plasma / Whole Blood for 1 assays Kit Components (order no. 26): 261 Mobile Phase 1 ml 2611 Standard Solution 3 ml 2613 Serum Calibrator, lyophil. 3 ml 262 Sample Preparation Vials 1 pcs P Precipitant 1 ml Reagent N 25 ml Manual Quick Reference Optional Components: Whole Blood Calibrator, lyophil. 5 x 2 ml Start Accessories: 273 Analytical Column with test chromatogram 2732 Guard Column Holder incl. 1 Guard Column Accessories: 2733 Guard Column 5 pcs. FK2 ClinLab Peristaltic pump FK21 Replacement tubing for peristaltic pump 2 pcs. FK5121 T-Union (PEEK), 1/16" FK581 PEEK-tubing (connection of prefilter and column) FK582 Stainless steel prefilter holder FK5821 Replacement filter for stainless steel prefilter holder 1 pcs. ClinChek Controls: 887 Serum Control, lyophil., Level I 1 x 5 ml 8871 Serum Control, lyophil., Level II 1 x 5 ml 8872 Serum Control, lyophil., Level III 1 x 5 ml 8873 Serum Control, lyophil., Level I, II, III 3 x 3 x 5 ml 8874 Whole Blood Control, lyophil., Level I 1 x 2 ml 8875 Whole Blood Control, lyophil., Level II 1 x 2 ml 8876 Whole Blood Control, lyophil., Level I, II 2 x 5 x 2 ml Diagnostics Injection interval: 1 min HPLC Analysis: centrifuge Inject 5 μl of the supernatant Combineable with B1 and B2 test kits 79

42 The combi kit enables the combined measurement of the vitamins B1, B2, and B6. It consists of the chromatography kit (order no. 27) and appropriate sample preparation kits (order nos. 271, 272, 276). The chromatography is performed with a single column for all B-vitamins in subsequent series of measurement. For switching the parameter (e.g. vitamin B1 --> vitamin B2) simply the parameter settings have to be changed (see HPLC para meters). By selecting the appropriate sample preparation kits, the customer is flexible to choose the parameters according to his needs. Vitamin Status Vitamin B1, B2 in Whole Blood and B6 in Plasma / Whole Blood (Combikit) Test Data On request HPLC Parameters Vitamin B1 Pump (Mobile Phase A + B): flow rate 1 ml/min ratio A : B = 93 : 7 Pump (Reagent N): flow rate.1 ml/min Injection volume: 5 μl Injection interval: 6 min HPLC-Thermostat: 35 C Detector (exc. / em.): 376 nm / 435 nm Retention times: Thiamine approx. 5.1 min TPP approx. 2.5 min Sample Preparation Vitamin B1: see page 74, Vitamin B2: see page 76, Vitamin B6: see page 78 Chromatograms See chromatograms on page 75 (Vitamin B1), 77 (Vitamin B2), and 79 (Vitamin B6) The combi kit consists of the chromatography kit (order no. 27) and the separate sample preparation kits (order nos. 271, 272 and 276). A: Chromatography 27 ClinRep Chromatography Kit for Vitamin B1, B2 and B6 for 1 assays Kit Components (order no. 27): 278 Mobile Phase A 4 x 278 (4 x 24 ml) 279 Mobile Phase B 2 x 279 (2 x 1 ml) 273 Analytical Column with test chromatogram 2733 Guard Column 5 pcs. FK5821 Replacement filter for stainless steel prefilter holder 1 pcs. Manual Quick Reference Accessories: 2732 Guard Column Holder incl. 1 Guard Column FK2 ClinLab Peristaltic pump FK21 Replacement tubing for peristaltic pump 2 pcs. FK5121 T-Union (PEEK), 1/16" FK581 PEEK-tubing (connection of prefilter and column) FK582 Stainless steel prefilter holder FK5821 Replacement filter for stainless steel prefilter holder 1 pcs. Diagnostics High flexibility: 1 Chromatography kit + 3 sample preparation kits HPLC Parameters Vitamin B2 Pump (Mobile Phase A + B): flow rate 1 ml/min ratio A : B = 8 : 2 Injection volume: 5 μl Injection interval: 1 min HPLC-Thermostat: 4 C Detector (exc. / em.): 45 nm / 53 nm Retention times: Riboflavin approx. 8.2 min FMN approx. 5.2 min FAD approx. 2.8 min HPLC Parameters Vitamin B6 Pump (Mobile Phase A + B): flow rate 1 ml/min ratio A : B = 1 : Pump (Reagent N): flow rate.2 ml/min Injection volume: 5 μl Injection interval: 1 min HPLC-Thermostat: 25 C Detector (exc. / em.): 37 nm / 47 nm Retention times: Pyridoxal approx. 8.8 min PLP approx. 5.2 min ClinChek Controls: 887 Serum Control, lyophil., Level I 1 x 5 ml 8871 Serum Control, lyophil., Level II 1 x 5 ml 8872 Serum Control, lyophil., Level III 1 x 5 ml 8873 Serum Control, lyophil., Level I, II, III 3 x 3 x 5 ml 8874 Whole Blood Control, lyophil., Level I 1 x 2 ml 8875 Whole Blood Control, lyophil., Level II 1 x 2 ml 8876 Whole Blood Control, lyophil., Level I, II 2 x 5 x 2 ml B: Sample Preparation 271 ClinRep Sample Preparation Kit for Vitamin B1 in Whole Blood for 1 assays Kit Components (order no. 271): Identical with order no. 24 (s. page 75); 272 ClinRep Sample Preparation Kit for Vitamin B2 in Whole Blood for 1 assays Kit Components (order no. 272): Identical with order no. 25 (s. page 77); 276 ClinRep Sample Preparation Kit for Vitamin B6 in Plasma and Whole Blood for 1 assays Kit Components (order no. 276): Identical with order no. 26 (s. page 79); } exception: Mobile Phase not included 81

43 The determination of 25-OH vitamin D (i.e. D2, D3) is used for the assessment of the vitamin D status. The RECIPE HPLC complete kit enables a quick and reliable quantification of both analytes from plasma and serum. The sample preparation consists of a simple precipitation step, a time consuming solid phase extraction is not required. The subsequent HPLC analysis is performed with an injection interval of 1 min only. For system check, calibration and internal quality control a ClinTest Test Solu tion, a ClinCal Serum Calibrator (traceable to NIST stand ard SRM 972) and ClinChek Serum Controls are available. Available soon: Additional product for a fully automated sample preparation with liquid handling systems and well plates Vitamin Status 25-OH Vitamin D2 / D3 in Plasma and Serum Test Data Linearity: μg/l (D2) μg/l (D3) Recovery: % LLOD: 1.1 μg/l (D2) 1. μg/l (D3) LLOQ: 3. μg/l (D2) 2.6 μg/l (D3) Intraassay precision: 2.7 % (D2) 2.5 % (D3) Interassay precision: 3.7 % (D2) 3.7 % (D3) HPLC Parameters Pump: isocratic pump, flow rate: 1. ml/min Injection volume: 5 μl Injection interval: 1 min UV-Detector: 264 nm HPLC-Thermostat: 4 C ClinChek Serum Control, Level I OH Vitamin D3: 6.89 min, 25-OH Vitamin D2: 7.84 min, IS: 8.94 min ClinChek Serum Control, Level II OH Vitamin D3: 6.87 min, 25-OH Vitamin D2: 7.83 min, IS: 8.94 min 35 ClinRep Complete Kit for 25-OH Vitamin D2 / D3 in Plasma and Serum for 1 assays Kit Components (order no. 35): 351 Mobile Phase 1 ml 3512 IS Internal Standard 5 ml 3513 Serum Calibrator, lyophil. 5 x 2 ml 3514 Test Solution, lyophil. 2 x 2 ml 352 Sample Preparation Vials with Reagent, lyophil. 1 pcs P Precipitant 5 ml Manual Quick Reference Start Accessories: 353 Analytical Column with test chromatogram 3532 Guard Column Holder incl. 1 Guard Column Diagnostics Sample Preparation Precipitation: 5 μl Precipitant P Accessories: 3533 Guard Column 5 pcs. FK581 PEEK tubing (connection of prefilter and column) FK582 Stainless steel prefilter holder FK5821 Replacement filter for stainless steel prefilter holder 1 pcs. Quick sample preparation (no solid phase extraction required) HPLC Analysis: 1. Add 4 μl sample 2. Add 4 μl Internal Standard IS mix, centrifuge Inject 5 μl of the supernatant ClinChek Controls: 358 Serum Control, lyophil., Level I 1 x 2 ml 3581 Serum Control, lyophil., Level II 1 x 2 ml 3582 Serum Control, lyophil., Level I, II 2 x 5 x 2 ml Injection interval: 1 min Traceable to NIST standard SRM

44 25-OH Vitamin D (i.e. D2, D3) is an important para - meter for the assessment of the vitamin D status. In addition to RECIPE's HPLC complete kit (see pages 82-83), a ClinRep Complete Kit for UHPLC systems is available. The RECIPE ClinRep UHPLC Complete Kit features a significantly increased sam - ple throughput with reduced buffer consumption due to the very short chromatography duration of only 2 minutes. For system check, calibration and internal quality control a ClinTest Test Solution, a ClinCal Serum Calibrator (traceable to NIST standard SRM 972) and ClinChek Serum Controls are available. Available soon: Additional product for a fully automated sample preparation with liquid handling systems and well plates Vitamin Status 25-OH Vitamin D2 / D3 in Plasma and Serum with UHPLC Test Data Linearity: μg/l (D2) μg/l (D3) Recovery: % LLOD: 2.8 μg/l (D2) 2.2 μg/l (D3) LLOQ: 4.6 μg/l (D2) 3.7 μg/l (D3) Intraassay precision: 4.3 % (D2) 4.6 % (D3) Interassay precision: 5.9 % (D2) 3.9 % (D3) UHPLC Parameters Pump: isocratic pump, flow rate:.75 ml/min Injection volume: 5 μl Injection interval: 2 min UV-Detector: 264 nm HPLC-Thermostat: 4 C Sample Preparation ClinChek Serum Control, Level I Intensity (AU) OH Vitamin D3:.68 min, 25-OH Vitamin D2:.77 min, IS: 1.58 min 1.58 ClinChek Serum Control, Level II OH Vitamin D3:.68 min, 25-OH Vitamin D2:.77 min, IS: 1.57 min 351 ClinRep Complete Kit for 25-OH Vitamin D2 / D3 in Plasma and Serum with UHPLC for 1 assays Kit Components (order no. 351): 351 Mobile Phase 1 ml 3512 IS Internal Standard 5 ml 3513 Serum Calibrator, lyophil. 5 x 2 ml 3514 Test Solution, lyophil. 2 x 2 ml 352 Sample Preparation Vials 1 pcs P Precipitant 5 ml Manual Quick Reference Start Accessories: 3513 Analytical Column with test chromatogram ClinChek Controls: 358 Serum Control, lyophil., Level I 1 x 2 ml 3581 Serum Control, lyophil., Level II 1 x 2 ml 3582 Serum Control, lyophil., Level I, II 2 x 5 x 2 ml 1.57 Diagnostics Precipitation: 5 μl Precipitant P First UHPLC Kit for Vitamin D UHPLC Analysis: 1. Add 4 μl sample 2. Add 4 μl Internal Standard IS mix, centrifuge Injection interval: 2 min Inject 1 μl of the supernatant Traceable to NIST standard SRM

45 TDM HPLC Complete Kits ClinRep TDM for Therapeutic Drug Monitoring Antiarrhythmics Amiodarone in Plasma Antiasthmatics Theophylline, Theobromine and Caffeine in Plasma Antiepileptic Drugs Antiepileptics in Serum Antiepileptics in Serum / Plasma, advanced Antiepileptics in Serum / Plasma with UHPLC Lamotrigine and Sulthiame in Plasma Levetiracetam (Keppra ) in Serum / Plasma Manual sample preparation with Gilson ASPEC Immunosuppressants Mycophenolic Acid in Plasma Psychoactive Drugs Atypical Neuroleptics in Plasma / Serum On-Line Analysis

46 Cardiac arrhythmias are major causes of morbidity and mortality throughout the world. Arrhythmias are controlled by medication of several drugs, such as amiodarone, an antiarrhythmic agent that helps to stabilise the normal rhythm of the heart. The re - sorp tion rate and the biological availability of amio - darone is low and extremely variable. The therapy therefore requires a close monitoring for the ad just - ment of the drug dosage. The RECIPE ClinRep Complete Kit allows for a quick, sensitive and reliable deter mination of amiodarone and the main meta - bolite desethylamiodarone. The sample preparation consists of a simple precipitation step. Antiarrhythmics Amiodarone in Plasma Test Data Linearity:.1-1 μg/ml Recovery: % LLOD:.7 μg/ml LLOQ:.1 μg/ml Intraassay precision: Amiodarone: 2.1 %, Desethylamiod.: 2.5 % Interassay precision: Amiodarone: 4. %, Desethylamiod.: 4.2 % ClinChek Serum Control, Level I IS: 2.82 min, Desethylamiodarone: 4.93 min, Amiodarone: 6.71 min ClinChek Serum Control, Level II IS: 2.82 min, Desethylamiodarone: 4.93 min, Amiodarone: 6.7 min 2 ClinRep Complete Kit for Amiodarone in Plasma for 1 assays TDM HPLC Parameters Pump: isocratic pump, flow rate:.8 ml/min Injection volume: 2 μl Injection interval: 8 min UV/VIS-Detector: 255 nm HPLC-Thermostat: 3 C Sample Preparation Kit Components (order no. 2): 21 Mobile Phase 1 ml 211 Standard Solution 3 ml 212 P Precipitant with Internal Standard 15 ml 213 Serum Calibrator, lyophil. 3 ml 22 Sample Preparation Vials with Reagent, lyophil. 2 x 22 (2 x 5 pcs.) Manual Quick Reference Start Accessories: 23 Analytical Column with test chromatogram 232 Guard Column Holder incl. 1 Guard Column Extraction: 1 μl sample HPLC Analysis: 15 μl Precipitant P (contains Internal Standard IS) centrifuge Inject 2 μl of the supernatant Refill Service: 231 Analytical Column with test chromatogram (original column needs to be returned) Accessories: 233 Guard Column 5 pcs. FK581 PEEK tubing (connection of prefilter and column) FK582 Stainless steel prefilter holder FK5821 Replacement filter for stainless steel prefilter holder 1 pcs. Simple and quick sample preparation ClinChek Controls: 28 Serum Control, lyophil., Level I 1 x 3 ml 281 Serum Control, lyophil., Level II 1 x 3 ml 282 Serum Control, lyophil., Level I, II 2 x 5 x 3 ml Linearity over a wide range Short run time 89

47 Theophylline, theobromine and caffeine are termed as methylxanthines and are used in the management of asthma bronchiale. Methylxanthines produce a relaxation of the bronchial smooth muscle and thus are helping to open up constricted airways (bronchodilators). The drug absorption and metabolism may be affected by many factors, inclu ding co-medication with other drugs (e.g. several AEDs, see pages 92-11). A monitoring of the plasma level is therefore essential to ensure that therapeutic, but not toxic drug doses are applied. The RECIPE ClinRep Complete Kit features simple and quick sample preparation, a costefficient analysis and ensures reliable results. Antiasthmatics Theophylline, Theobromine and Caffeine in Plasma Test Data Linearity: mg/l Recovery: approx. 7 % LLOD: Theophylline:.8 mg/l Theobromine:.6 mg/l Caffeine:.6 mg/l LLOQ: Theophylline: 1.7 mg/l Theobromine: 1.3 mg/l Caffeine: 1.4 mg/l Intraassay precision: 2.5 % Interassay precision: 1.7 % HPLC Parameters Pump: isocratic pump, flow rate: 1.5 ml/min Injection volume: 2 μl Injection interval: 8 min UV/VIS-Detector: 273 nm HPLC-Thermostat: 37 C ClinChek Plasma Control, Level I Theobromine: 1.8 min, Theophylline: 2.66 min, IS: 3.26 min, Caffeine: 5.83 min ClinChek Plasma Control, Level II Theobromine: 1.83 min, Theophylline: 2.69 min, IS: 3.29 min, Caffeine: 5.85 min 12 ClinRep Complete Kit for Theophylline, Theobromine and Caffeine in Plasma for 1 assays Kit Components (order no. 12): 121 Mobile Phase 1 ml 1211 Standard Solution 4 ml 1212 P Precipitant with Internal Standard IS 15 ml 1213 Plasma Calibrator, lyophil. 3 ml 122 Sample Preparation Vials with Reagent, lyophil. 2 x 122 (2 x 5 pcs.) 1221 D Diluting Solution 25 ml Manual Quick Reference Start Accessories: 123 Analytical Column with test chromatogram FK7 manu-cart cartridgeholder, one time accessory 1 set TDM Sample Preparation Extraction: Dilution: 1 μl plasma 15 μl Precipitant P (contains Internal Standard IS) centrifuge Accessories: FK581 PEEK tubing (connection of prefilter and column) FK582 Stainless steel prefilter holder FK5821 Replacement filter for stainless steel prefilter holder 1 pcs. ClinChek Controls: 128 Plasma Control, lyophil., Level I 1 x 3 ml 1281 Plasma Control, lyophil., Level II 1 x 3 ml 1282 Plasma Control, lyophil., Level I, II 2 x 5 x 3 ml Simultaneous determination of 3 methylxanthines 5 μl supernatant 25 μl Diluting Solution D HPLC Analysis: Inject 2 μl of the diluted supernatant Simple and quick sample preparation Low cost per test 91

48 Antiepileptic drugs (AED) are the mainstay of epilepsy treat ment. The medication enables the patient to live free of epileptic seizures. Depending on the type of epilepsy, several AEDs with diverse activity mechanisms may be used for the management of the disease. For the monitoring of the drug level, this ClinRep Complete Kit allows for the simultaneous determination of 13* AEDs and metabolites. * Carbamazepine, carbamazepine-epoxide, N-desmethylmethsuximide, eslicarbazepine, ethosuximide, 1-hydroxycarbamazepine, lamotrigine, oxcarbazepine, PEMA, phenobarbital, phenytoin, primidone, sulthiame Antiepileptic Drugs Antiepileptics in Serum Test Data Linearity: Lamotrig., Sulthiame:.5-5 μg/ml Other Antiepileptics:.3-3 μg/ml Recovery: % LLOD: Lamotrig., Sulthiame:.2 μg/ml Other Antiepileptics:.1 μg/ml LLOQ: Lamotrig., Sulthiame:.5 μg/ml Other Antiepileptics:.3 μg/ml Intraassay precision: 2.3 % Interassay precision: 2.8 % HPLC Parameters Pump: isocratic pump, flow rate: 1. ml/min Injection volume: 1 μl Injection interval: 15 min UV/VIS-Detector: Lamotrig., Sulthiame: 265 nm Other Antiepileptics: 25 nm HPLC-Thermostat: 55 C ClinChek Serum Control, Level II, recorded at 25 nm: PEMA: 1.39 min, Ethosuximide: 1.65 min, Primidone: 2.1 min, 1-Hydroxy-carbamazepine: 3.43 min, Phenobarbital: 3.83 min, N-Desmethylmethsuximide: 4.25 min, Carbamazepine-epoxide: 4.98 min, Oxcarbazepine: 6.13 min, IS: 8.2 min, Phenytoin: min, Carbamazepine: min ClinChek Plasma Control, Level II, recorded at 265 nm: Sulthiame: 1.9 min, Lamotrigine: 2.74 min, IS: 8. min 15 ClinRep Complete Kit for Antiepileptics in Serum for 1 assays Kit Components (order no. 15): 151 Mobile Phase 1 ml 1511 Standard Solution Antiepileptics 3 ml 1512 P Precipitant with Internal Standard IS 15 ml 1513 Serum Calibrator Antiepileptics, lyophil. 3 ml 152 Sample Preparation Vials with Reagent, lyophil. 2 x 152 (2 x 5 pcs.) 1521 D Diluting Solution 1 ml Manual Quick Reference Optional Components: Standard Solution for Lamotrigine and Sulthiame 3 ml Plasma Calibrator for Lamotrigine and Sulthiame, lyophil. 3 ml Start Accessories: 153 Analytical Column with test chromatogram 1532 Guard Column Holder incl. 1 Guard Column TDM Sample Preparation Refill Service: 1531 Analytical Column with test chromatogram (original column needs to be returned) Simultaneous analysis of 13 antiepileptic drugs Extraction: 1 μl sample Dilution: 15 μl Precipitant P (contains Internal Standard IS) centrifuge Accessories: 1533 Guard Column 5 pcs. FK581 PEEK tubing (connection of prefilter and column) FK582 Stainless steel prefilter holder FK5821 Replacement filter for stainless steel prefilter holder 1 pcs. Efficient sample clean-up Robust and fast chromatography (injection interval: 15 min) 1 μl supernatant 1 μl Diluting Solution D HPLC Analysis: Inject 1 μl of the diluted supernatant ClinChek Controls: 158 Serum Control Antiepileptics, lyophil., Level I 1 x 3 ml 1581 Serum Control Antiepileptics, lyophil., Level II 1 x 3 ml 1582 Serum Control Antiepileptics, lyophil., Level I, II 2 x 5 x 3 ml 1518 Plasma Control for Lamotrigine and Sulthiame, lyophil., Level I 1 x 3 ml Plasma Control for Lamotrigine and Sulthiame, lyophil., Level II 1 x 3 ml Plasma Control for Lamotrigine and Sulthiame, lyophil., Level I, II 2 x 5 x 3 ml 93

49 In addition to the reliable ClinRep Complete Kit with order no. 15 (see pages 92-93), RECIPE Antiepileptic Drugs ClinChek Serum Control, Level II (order no. 1481) ClinChek Serum Control, Level II (order no ) offers a new test kit with an advanced chromatography and an extended analyte spectrum. The kit features simultaneous quantification of 16 different antiepileptics and clinically relevant metabolites, in - cluding novel drugs such as rufinamide, lacosamide and eslicarbazepine. By use of the same analytical column the kit can easily be combined with the ClinRep Complete Kit for Levetiracetam (see pages 1-11). Antiepileptics in Serum / Plasma, advanced Test Data The test data are available on request TDM Available soon: Additional product for a fully automated sample preparation with liquid handling systems and well plates HPLC Parameters Pump: Injection volume: Injection interval: UV-Detector: isocratic pump, flow rate: 1.8 ml/min 1 μl 15 min (9 min*) 25 nm Ethosuximide:.77 min, Primidone: 1.7 min, Sulthiame: 1.35 min, Lamotrigine: 1.65 min, 1-Hydroxy-Carbamazepine: 2.46 min, Phenobarbital: 2.94 min, Carbamazepine-epoxide: 4.11 min, Oxcarbazepine: 5.57 min, IS: 7.45 min, Carbamazepine: min, Phenytoin: min Lacosamide: 1.24 min, Zonisamide: 1.48 min, Felbamate: 1.69 min, Rufinamide: 1.85 min, N-Desmethylmethsuximide: 3.25 min, IS: 7.45 min HPLC-Thermostat: 3 C 14 ClinRep Complete Kit, advanced, for Antiepileptics in Serum / Plasma for 1 assays * In case samples do not contain carbamazepine and phenytoin, the injection interval can be reduced to 9 min. Sample Preparation Precipitation: 1 μl sample 2 μl Precipitant P (contains Internal Standard) Kit Components (order no. 14): 141 Mobile Phase 1 ml 1411 Standard Solution Antiepileptics 3 3 ml 1412 P Precipitant with Internal Standard 2 ml 1413 Serum Calibrator Antiepileptics 3, lyophil. 3 ml 142 Sample Preparation Vials 1 pcs D Diluting Solution 25 ml Manual Quick Reference Dilution: centrifuge 15 μl supernatant 25 μl Diluting Solution D Optional Components: Standard Solution Antiepileptics 4 3 ml Standard Solution for Lamotrigine and Sulthiame 3 ml Serum Calibrator Antiepileptics 4, lyophil. 3 ml Plasma Calibrator for Lamotrigine and Sulthiame, lyophil. 3 ml HPLC Analysis: Inject 1 μl of the diluted supernatant Start Accessories: 143 Analytical Column with test chromatogram Advanced chromatography with 16 AEDs Injection interval: 15 min (9 min) Accessories: FK581 PEEK tubing (connection of prefilter and column) FK582 Stainless steel prefilter holder FK5821 Replacement filter for stainless steel prefilter holder 1 pcs. ClinChek Controls: 148 Serum Control Antiepileptics 3, lyophil., Level I 1 x 3 ml 1481 Serum Control Antiepileptics 3, lyophil., Level II 1 x 3 ml 1482 Serum Control Antiepileptics 3, lyophil., Level I, II 2 x 5 x 3 ml 1418 Serum Control Antiepileptics 4, lyophil., Level I 1 x 3 ml Serum Control Antiepileptics 4, lyophil., Level II 1 x 3 ml Serum Control Antiepileptics 4, lyophil., Level I, II 2 x 5 x 3 ml 1518 Plasma Control for Lamotrigine and Sulthiame, lyophil., Level I 1 x 3 ml Plasma Control for Lamotrigine and Sulthiame, lyophil., Level II 1 x 3 ml Plasma Control for Lamotrigine and Sulthiame, lyophil., Level I, II 2 x 5 x 3 ml 1 analytical column for 16 AEDs and Levetiracetam 95

50 This new ClinRep UHPLC Complete Kit shows an identical analyte spectrum as the ClinRep HPLC Antiepileptic Drugs ClinChek Serum Control, Level II (order no. 1481) ClinChek Serum Control, Level II (order no ) Complete Kit with order no. 14 (see pages 94-95). Thus, the following 16 substances can be quanti fied simultaneously: carbamazepine, eslicarbazepine, ethosuximide, felbamate, lacosamide, lamotrigine, oxcarbazepine, phenobarbital, pheny - toin, primidone, rufinamide, sulthiame and zonisa- Antiepileptics in Serum / Plasma with UHPLC Intensity (AU) Intensity (AU) TDM mide as well as the pharmacologically active metabolites N-desmethylmethsuximide, 1-hydroxy-car - ba mazepine and carbamazepine-epoxide. The chro - matographic separation is performed with an injection interval of 5 min only. Available soon: Additional product for a fully automated sample preparation with liquid handling systems and well plates Test Data The test data are available on request. UHPLC Parameters Pump: binary gradient pump, flow rate:.4 ml/min Injection volume: 2 μl Injection interval: 5 min UV-Detector: 25 nm HPLC-Thermostat: 3 C.. Ethosuximide: 1.39 min, Primidone: 1.71 min, Sulthiame: 1.8 min, Lamotrigine: 1.92 min, 1-Hydroxy-Carbamazepine: 2.33 min, Phenobarbital: 2.65 min, Carbamazepine-epoxide: 2.92 min, Oxcarbazepine: 3.16 min, IS: 3.44 min, Carbamazepine: 3.64 min, Phenytoin: 3.71 min Lacosamide: 1.79 min, Zonisamide: 1.86 min, Felbamate: 1.99 min, Rufinamide: 2.5 min, N-Desmethylmethsuximide: 2.8 min, IS: 3.44 min 141 ClinRep Complete Kit for Antiepileptics in Serum / Plasma for 1 assays Sample Preparation Precipitation: Dilution: 1 μl sample 2 μl Precipitant P (contains Internal Standard) centrifuge 15 μl supernatant 25 μl Diluting Solution D Kit Components (order no. 141): 1418 Mobile Phase A 4 ml 1419 Mobile Phase B 2 ml 1411 Standard Solution Antiepileptics 3 3 ml 1412 P Precipitant with Internal Standard 2 ml 1413 Serum Calibrator Antiepileptics 3, lyophil. 3 ml 142 Sample Preparation Vials 1 pcs D Diluting Solution 25 ml Manual Quick Reference UHPLC Analysis: Inject 2 μl of the diluted supernatant Optional Components: Standard Solution Antiepileptics 4 3 ml Standard Solution for Lamotrigine and Sulthiame 3 ml Serum Calibrator Antiepileptics 4, lyophil. 3 ml Plasma Calibrator for Lamotrigine and Sulthiame, lyophil. 3 ml Start Accessories: 1413 Analytical Column with test chromatogram Simultaneous determination of 16 AEDs including: Lacosamide Zonisamide Felbamate Rufinamide Eslicarbazepine ClinChek Controls: 148 Serum Control Antiepileptics 3, lyophil., Level I 1 x 3 ml 1481 Serum Control Antiepileptics 3, lyophil., Level II 1 x 3 ml 1482 Serum Control Antiepileptics 3, lyophil., Level I, II 2 x 5 x 3 ml 1418 Serum Control Antiepileptics 4, lyophil., Level I 1 x 3 ml Serum Control Antiepileptics 4, lyophil., Level II 1 x 3 ml Serum Control Antiepileptics 4, lyophil., Level I, II 2 x 5 x 3 ml 1518 Plasma Control for Lamotrigine and Sulthiame, lyophil., Level I 1 x 3 ml Plasma Control for Lamotrigine and Sulthiame, lyophil., Level II 1 x 3 ml Plasma Control for Lamotrigine and Sulthiame, lyophil., Level I, II 2 x 5 x 3 ml Injection interval: 5 min 97

51 Lamotrigine and sulthiame are important antiepileptic drugs (AED) in the management of several types of epilepsy. This ClinRep Complete Kit is especially designed for the determination of lamotrigine and sulthiame from plasma. It features a short time for analysis (7 min) and excellent test precision. Antiepileptic Drugs Lamotrigine and Sulthiame in Plasma Test Data Linearity:.5-5 μg/ml Recovery: % LLOD:.2 μg/ml LLOQ:.5 μg/ml Intraassay precision: 2.4 % Interassay precision: 2.6 % ClinChek Plasma Control, Level I: Sulthiame: 1.74 min, Lamotrigine: 2.44 min, IS: 4.64 min ClinChek Plasma Control, Level II: Sulthiame: 1.75 min, Lamotrigine: 2.45 min, IS: 4.64 min TDM HPLC Parameters Pump: isocratic pump, flow rate: 1. ml/min Injection volume: 2 μl Injection interval: 7 min* UV/VIS-Detector: 265 nm HPLC-Thermostat: 55 C * In case the sample contains carbamazepine, the run time must be extended to 15 min. Sample Preparation Extraction: Dilution: 1 μl plasma 15 μl Precipitant P (contains Internal Standard IS) centrifuge 1 μl supernatant 1 μl Diluting Solution D 151 ClinRep Complete Kit for Lamotrigine, Sulthiame in Plasma for 1 assays Kit Components (order no. 151): 151 Mobile Phase 1 ml Standard Solution 3 ml P Precipitant with Internal Standard 15 ml Plasma Calibrator, lyophil. 3 ml 152 Sample Preparation Vials with Reagent, lyophil. 2 x 152 (2 x 5 pcs.) 1521 D Diluting Solution 1 ml Manual Quick Reference Start Accessories: 153 Analytical Column with test chromatogram 1532 Guard Column Holder incl. 1 Guard Column Refill Service: 1531 Analytical Column with test chromatogram (original column needs to be returned) Accessories: 1533 Guard Column 5 pcs. FK581 PEEK tubing (connection of prefilter and column) FK582 Stainless steel prefilter holder FK5821 Replacement filter for stainless steel prefilter holder 1 pcs. Injection interval: 7 min HPLC Analysis: Inject 2 μl of the diluted supernatant ClinChek Controls: 1518 Plasma Control, lyophil., Level I 1 x 3 ml Plasma Control, lyophil., Level II 1 x 3 ml Plasma Control, lyophil., Level I, II 2 x 5 x 3 ml Excellent test precision 99

52 The RECIPE analytical method for levetiracetam completes the RECIPE kit portfolio for the analysis of antiepileptic drugs (AED). The sample preparation can be performed either manually (complete kit with order no. 155) or automated with the Gilson ASPEC pipetting system (order no. 156). By the use of the same analytical column, the kits can easily be combined with the AED test kit with order no. 14 (see pages 94-95) which allows the quantification of further 16 different drugs and clinically relevant metabolites. Antiepileptic Drugs Levetiracetam (Keppra ) in Serum and Plasma Manual Sample Prep. / with Gilson ASPEC ClinChek Serum Control, Level I ClinChek Serum Control, Level II TDM Test Data Manual / Automated Processing (Gilson ASPEC ) Linearity:.5-1 /.5-2 mg/l Recovery: / 9-12 % LLOD:.15 mg/l LLOQ:.5 mg/l Intraassay precision: 1.5 / 1.2 % Interassay precision: 1.9 / 1.9 % HPLC Parameters Pump: isocratic pump, flow rate: 1.4 ml/min Injection volume: 2 μl Injection interval: 6 min UV-Detector: 25 nm HPLC-Thermostat: 3 C Sample Preparation Manual / Automated Processing (Gilson ASPEC ) Extraction: Apply (conditioned* sample preparation column): Levetiracetam: 2.58 min, IS: 4.93 min Levetiracetam: 2.57 min, IS: 4.93 min ClinRep Complete Kit for Levetiracetam in Serum / Plasma 155 manual sample preparation, for 1 assays 156 with Gilson ASPEC, for 2 assays Kit Components : order no Mobile Phase 1 ml 1552 Sample Preparation Columns 2 x 1552 (2 x 5 pcs.) W Washing Solution 1 3 x (3 x 2 ml) order no Mobile Phase 2 x 1551 (2 x 1 ml) 1562 Sample Preparation Columns 2 x 1562 (2 x 1 pcs.) W Washing Solution 1 2 x (2 x 2 ml) order nos. 155 / Standard Solution 3 ml IS Internal Standard 1 ml Serum Calibrator, lyophil. 3 ml Conditioning Reagent 3 ml W Washing Solution 2 1 ml E Eluting Reagent 1 ml User Manual Quick Reference Sample (1 μl / 5 μl) Internal Standard IS (1 μl / 5 μl) Start Accessories: 143 Analytical Column with test chromatogram 1 analytical column for levetiracetam and further 16 AEDs Elution: HPLC Analysis: wash with Apply Eluting Reagent E (1 ml / 5 μl) 1. Washing Solution W1 (3 ml / 1 ml) 2. Washing Solution W2 (1 ml / 33 μl) Accessories: FK581 PEEK tubing (connection of prefilter and column) FK582 Stainless steel prefilter holder FK5821 Replacement filter for stainless steel prefilter holder 1 pcs. ClinChek Controls: 1558 Serum Control, lyophil., Level I 1 x 3 ml Serum Control, lyophil., Level II 1 x 3 ml Serum Control, lyophil., Level I, II 2 x 5 x 3 ml Optional: method with automated sample preparation Inject 2 μl * Conditioning with Conditioning Reagent and Washing Solution W1 11

53 Mycophenolate mofetil (MMF) belongs to the newer immunosuppressive drugs and is usually used in combination with cyclosporine A or tacrolimus. As a pro-drug, MMF is rapidly hydrolised in vivo to its active constituent mycophenolic acid (MPA). In order to reach an optimal therapeutic efficiency, i.e. to maxi mise drug efficiency while minimising its toxicity, the administration of MMF requires monitoring of the MPA concentration with subsequent do sage adjustment. For this purpose, our ClinRep HPLC Complete Kit provides an easy and quick sample preparation and enables a reliable and fast analysis. Immunosuppressants Mycophenolic Acid in Plasma Test Data Linearity:.1-4 mg/l Recovery: % LLOD:.6 mg/l LLOQ:.1 mg/l Intraassay precision: 3.3 % Interassay precision: 4. % ClinChek Plasma Control, Level I: Mycophenolic acid: 4.99 min, IS: 6.5 min ClinChek Plasma Control, Level II: Mycophenolic acid: 4.99 min, IS: 6.5 min TDM HPLC Parameters Pump: isocratic pump, flow rate: 1.2 ml/min Injection volume: 5 μl Injection interval: 7 min UV/VIS-Detector: 215 nm HPLC-Thermostat: 3 C Sample Preparation Precipitation: 29 ClinRep Complete Kit for Mycophenolic Acid in Plasma for 1 assays Kit Components (order no. 29): 291 Mobile Phase 1 ml 2914 Test Solution 3 ml 2912 IS Internal Standard 2 ml 2913 Plasma Calibrator, lyophil. 3 ml 292 Sample Preparation Vials 1 pcs P Precipitant 2 ml Manual Quick Reference Start Accessories: 293 Analytical Column with test chromatogram 1 μl plasma HPLC Analysis: 2 μl Internal Standard IS centrifuge 2 μl Precipitant P Accessories: FK581 PEEK-tubing (connection of prefilter and column) FK582 Stainless steel prefilter holder FK5821 Replacement filter for stainless steel prefilter holder 1 pcs. Inject 5 μl of the supernatant ClinChek Controls: 298 Plasma Control, lyophil., Level I 1 x 3 ml 2981 Plasma Control, lyophil., Level II 1 x 3 ml 2982 Plasma Control, lyophil., Level III 1 x 3 ml 2983 Plasma Control, lyophil., Level I, II, III 3 x 3 x 3 ml Easy and quick sample preparation Reliable chromatography Injection interval: 7 min 13

54 The drugs olanzapine, clozapine, quetiapine, risperidone, and paliperidone (= 9-OH-risperidone) be long to the class of the so called atypical neu - ro leptics and are used for the treatment of schizophrenia. Co-medication, smoking, caffeine and food are factors that extensively influence their metabolism and thus lead to a high intra- and interindividual variability of drug concentrations in blood. In order to avoid severe side effects by overdosing and to en - sure an optimal therapeutic effect, therapeutic drug monitoring (TDM) is required. The RECIPE Com plete Kit represents a fully automated, robust on-line technique, that allows for a direct sample injection into the HPLC system. Fully automated method On-line sample preparation 1 % recovery Psychoactive Drugs Atypical Neuroleptics in Plasma / Serum On-Line Analysis Test Data Linearity: Olz / D-Olz: 5 / 1-1 μg/l Clz / D-Clz: 6 / 5-5 μg/l Qtp: 1-2 μg/l Plp, Rsp: 1-2 μg/l Recovery: 1 % LLOD: 2 μg/l (Olz, Clz, D-Clz), 4 μg/l (D-Olz, Qtp).4 μg/l (Plp, Rsp) LLOQ: 5 μg/l (Olz), 6 μg/l (Clz), 1 μg/l (D-Olz, Qtp), 4 μg/l (D-Clz) 1 μg/l (Plp, Rsp) Intraassay precision:.2-2 % Interassay precision: 1-6 % HPLC Parameters A: Determination of Olz, D-Olz, Clz, D-Clz, Qtp B: Determination of Plp, Rsp Isocratic pump 1 (SPE buffer): flow rates:.5 / 1. ml/min Isocratic pump 2 (mobile phase): flow rate: A: 1.3 ml/min B: 1. ml/min Switching valve: 6-port/3-channel (order no. FK112) Injection volume: A: 25 μl, B: 75 μl Injection interval: A: 22 min, B: 2 min UV-detector: A: 254 nm, B: 28 nm HPLC-thermostat: 3 C Sample Pretreatment Addition of IS: A: Add 2 μl Internal Standard IS/ml sample B: Add 1 μl Internal Standard IS/ml sample On-Line Analysis: centrifuge Chromatogram of the plasma calibrator, order no. 413 (+ 2 μl Internal Standard IS per ml sample, order no. 412) Desmethylolanzapine (D-Olz): 9.51 min, Olanzapine (Olz): min, Desmethylclozapine (D-Clz): min, Internal Standard IS: min, Clozapine (Clz): min, Quetiapine (Qtp): 2.25 min Chromatogram of the plasma calibrator, order no (+ 1 μl Internal Standard IS per ml sample, order no. 412) Paliperidone (Plp): 1.47 min, Risperidone (Rsp): min, Internal Standard IS: min 4 ClinRep Complete Kit for Atypical Neuroleptics in Plasma / Serum for 1 assays Kit Components (order no. 4): 49 SPE-Buffer 2 x 49 (2 x 1 ml) 41 Mobile Phase 2 x 41 (2 x 2 ml) 413 Plasma Calibrator, lyophil. 5 x 3 ml Manual Quick Reference Optional Components: 412 IS Internal Standard 2 ml 414 Test Solution, lyophil. 5 x 2 ml 4113 Plasma Calibrator, lyophil., for Risperidone and Paliperidone 5 x 5 ml 4114 Test Solution, for Risperidone and Paliperidone 15 ml Start Accessories: 43 Analytical Column with test chromatogram 431 SPE-Column 432 Guard Column Holder incl. 1 Guard Column 433 Guard Column 5 pcs. FK74 Inline-Filter (stainless steel sieve, free of dead volume) Refill Service: 434 SPE-Column, refill (original column needs to be returned) Accessories: FK112 Switching valve, Sykam (6-port/3-channel) incl. electr. drive, PEEK FK733 Endfittings 2 pcs. FK734 Sealings and sieves 4 pcs. each FK735 Endstoppers 2 pcs. ClinChek Controls: 48 Plasma Control, lyophil., Level I 1 x 3 ml 481 Plasma Control, lyophil., Level II 1 x 3 ml 482 Plasma Control, lyophil., Level I, II 2 x 5 x 3 ml 418 Plasma Control, lyophil., for Risperidone and Paliperidone, Level I 1 x 5 ml 4181 Plasma Control, lyophil., for Risperidone and Paliperidone, Level II 1 x 5 ml 4182 Plasma Control, lyophil., for Risperidone and Paliperidone, Level I, II 2 x 5 x 5 ml TDM A: Inject 25 μl B: Inject 75 μl 15

55 HBM HPLC Complete Kits ClinTox HBM for Human Biomonitoring Benzene and Derivatives ortho-cresol and Phenol in Urine Hippuric Acid and Methylhippuric Acids in Urine t,t-muconic Acid in Urine Polycyclic Aromatic Hydrocarbons (PAH) 1-Hydroxypyrene in Urine On-Line Analysis

56 o-cresol is a minor metabolite of toluene and serves for the assessment of an exposure to toluene, which is a frequently used solvent in glues, paints and thinners. In contrast to hippuric acid (see pages ), which is the main metabolite of toluene, o-cresol is not a physiological component of urine and therefore reflects the internal exposure to wards the pollu tant. Phenol is the main metabolite of benzene and is used for the assessment of benzene as well as of phenol itself. The RECIPE ClinTox Com plete Kit provides an excellent analytical sensitivity and ensures a reliable biomonitoring of both analytes. The sample clean up is performed via solid phase extrac tion (SPE). Enzymatic release of the analytes Benzene and Derivatives ortho-cresol and Phenol in Urine Test Data Linearity: o-cresol:.5-5 mg/l, Phenol:.2-5 mg/l Recovery: % LLOD: o-cresol:.3 mg/l, Phenol:.1 mg/l LLOQ: o-cresol:.5 mg/l, Phenol:.2 mg/l Intraassay precision: o-cresol: 2.4 %, Phenol: 3.2 % Interassay precision: o-cresol: 2.8 %, Phenol: 4.8 % HPLC Parameters Pump: isocratic pump, flow rate: 1. ml/min Injection volume: 1-2 μl Injection interval: 15 min Fluorescence detector: 277 nm (exc.), 3 nm (em.) HPLC-Thermostat: 3 C Sample Preparation Enzymatic treatment: 25 μl urine Extraction: Elution: 25 μl Reagent C Transfer the whole sample to a conditioned sample preparation column 5 μl Internal Standard IS 5 μl Reagent D incubate (37 C, 2-24 h) wash (2 x 2 ml Reagent B) ClinChek Urine Control, Level I: Phenol: 5.62 min, p-cresol: 9.87 min, o-cresol: 11.6 min, IS: min ClinChek Urine Control, Level II: Phenol: 5.62 min, p-cresol: 9.87 min, o-cresol: 11.7 min, IS: min 53 ClinTox Complete Kit for o-cresol and Phenol in Urine for 1 assays Kit Components (order no. 53): 531 Mobile Phase 1 ml 5312 IS Internal Standard 5 ml 9925 Urine Calibrator, lyophil. 5 x 5 ml 5232 Sample Preparation Columns 2 x 5232 (2 x 5 pcs.) 5321 Reagent A 4 ml 5322 Reagent B 2 x 5322 (2 x 3 ml) 5323 Reagent C 25 ml 5324 Reagent D 3 x 5324 (3 x 2 ml) Manual Quick Reference Start Accessories: 5233 Analytical Column with test chromatogram Accessories: FK3 Thermocult Incubator (37 C) FK581 PEEK tubing (connection of prefilter and column) FK582 Stainless steel prefilter holder FK5821 Replacement filter for stainless steel prefilter holder 1 pcs. FK62 Sample vial with screw thread, clear glass, 1.5 ml 1 pcs. FK622 Screw cap with hole for order no. FK62 1 pcs. FK623 PTFE-septum for order no. FK622 1 pcs. ClinChek Controls: 8925 Urine Control, lyophil., Level I, II 2 x 5 x 5 ml HBM Sample clean-up via SPE Injection interval: 15 min HPLC Analysis: Elute with 2 ml Reagent A Inject 1-2 μl collect the eluate High analytical sensitivity 19

57 This ClinTox Complete Kit is designed for the reliable biomonitoring of hippuric acid and of o-, m- and p-methylhippuric acid. Those compounds are the uri nary metabolites of toluene and of the cor - res pon ding xylenes and thus reflect an exposure level towards these pollutants. Sample preparation co lumns and ana ly ti cal column of this kit can also be used for the determination of o-cresol and phenol in urine (see pages 18-19). Benzene and Derivatives Hippuric Acid and Methylhippuric Acids in Urine ClinChek Urine Control, Level I: ClinChek Urine Control, Level II: HBM Test Data Linearity: Hippuric Acid: 5-1 mg/l, Methylhippuric Acids: 5-5 mg/l Recovery: % LLOD: Hippuric Acid: 3 mg/l, Methylhip. Acids: 2 mg/l LLOQ: Hippuric Acid: 5 mg/l, Methylhip. Acids: 4 mg/l Intraassay precision: Hippuric Acid: 2. %, Methylhip. Acids: 2.1 % Interassay precision: Hippuric Acid: 2.3 %, Methylhip. Acids: 3.2 % HPLC Parameters Pump: isocratic pump, flow rate: 1. ml/min Injection volume: 2 μl Injection interval: 8 min UV-Detector: 23 nm HPLC-Thermostat: 3 C Hippuric acid: 3.19 min, o-methylhippuric acid: 4.23 min, IS: 5.7 min, m-/p-methylhippuric acid: 6.43 min Hippuric acid: 3.24 min, o-methylhippuric acid: 4.29 min, IS: 5.14 min, m-/p-methylhippuric acid: 6.52 min 52 ClinTox Complete Kit for Hippuric Acid and Methylhippuric Acids in Urine for 1 assays Kit Components (order no. 52): 521 Mobile Phase 1 ml 5211 Standard Solution 3 ml 5212 IS Internal Standard 1 ml 9922 Urine Calibrator, lyophil. 5 x 5 ml 5232 Sample Preparation Columns 2 x 5232 (2 x 5 pcs.) 5221 Reagent A 4 ml 5222 Reagent B 2 x 5222 (2 x 4 ml) Manual Quick Reference Start Accessories: 5233 Analytical Column with test chromatogram Accessories: FK581 PEEK tubing (connection of prefilter and column) FK582 Stainless steel prefilter holder FK5821 Replacement filter for stainless steel prefilter holder 1 pcs. 7 8 Sample Preparation Dilution: ClinChek Controls: 8922 Urine Control, lyophil., Level I, II 2 x 5 x 5 ml Sample clean-up via SPE 1 μl urine Extraction: 1 μl Internal Standard IS 2 ml Reagent B Injection interval: 8 min Elution: Transfer the whole sample to a conditioned sample preparation column wash (2 x 2 ml Reagent B) High analytical sensitivity HPLC Analysis: Elute with 2 ml Reagent A collect the eluate Inject 2 μl 111

58 t,t-muconic acid is a minor metabolite of benzene and serves for the assessment of an occupational benzene exposure. In contrast to phenol (see pages 18-19), t,t-muconic acid is not a physiological com po nent of urine and thus provides a higher diagnos tic specificity. This ClinTox Com plete Kit represents a robust and sensitive method with a highly selective sample preparation, followed by isocratic separation with UV detection. Benzene and Derivatives t,t-muconic Acid in Urine Test Data Linearity:.24-2 mg/l Recovery: 75-8 % LLOD:.7 mg/l LLOQ:.24 mg/l Intraassay precision: 5.9 % Interassay precision: 5.5 % ClinChek Urine Control, Level I: t,t-muconic acid: 5.83 min, IS: 7.15 min ClinChek Urine Control, Level II: t,t-muconic acid: 5.75 min, IS: 7.15 min HBM HPLC Parameters Pump: gradient pump, flow rate: 1. ml/min Injection volume: 5 μl Injection interval: 18 min UV-Detector: 264 nm HPLC-Thermostat: 45 C Sample Preparation Dilution: 1 ml urine Extraction: 15 μl Internal Standard IS 1 ml Reagent B 51 ClinTox Complete Kit for t,t-muconic Acid in Urine for 1 assays Kit Components (order no. 51): 518 Mobile Phase A 2 x 518 (2 x 1 ml) 519 Mobile Phase B 8 ml 5111 Standard Solution 3 ml 5112 IS Internal Standard 15 ml 9922 Urine Calibrator, lyophil. 5 x 5 ml 512 Sample Preparation Columns 2 x 512 (2 x 5 pcs.) 5121 Reagent A 3 ml 5122 Reagent B 4 ml 5123 Reagent C 3 ml 5124 Reagent D 3 ml Manual Quick Reference Start Accessories: 513 Analytical Column with test chromatogram Elution: Transfer the whole sample to a conditioned sample preparation column wash (2 x 1.5 ml Reagent C) Accessories: FK581 PEEK tubing (connection of prefilter and column) FK582 Stainless steel prefilter holder FK5821 Replacement filter for stainless steel prefilter holder 1 pcs. Elute with 2 x 1.5 ml Reagent D ClinChek Controls: 8922 Urine Control, lyophil., Level I, II 2 x 5 x 5 ml High diagnostic specificity HPLC Analysis: Inject 5 μl collect the eluates Highly selective sample preparation High analytical sensitivity 113

59 Urinary 1-hydroxypyrene is used as a biological index for the assessment of an exposure to polycyclic aromatic hydrocarbons (PAH). Many individual PAHs are genotoxic carcinogens and are formed by the incomplete combustion of fossil fuels. The RECIPE ClinTox Complete Kit is designed for the automated determination of urinary 1-hydroxypyrene in order to estimate an environmental or occu pational related PAH exposure. The sample pre - paration is performed on-line by column switching using a highly selective SPE-column (SPE: solid phase extraction). PAH Polycyclic Aromatic Hydrocarbons 1-Hydroxypyrene in Urine On-Line Analysis Test Data Linearity: 1-24 ng/l Recovery: 1 % LLOD: 2 ng/l LLOQ: 1 ng/l Intraassay precision: 2.6 % Interassay precision: 2.9 % ClinChek Urine Control, Level I: Hydroxypyrene: min ClinChek Urine Control, Level II: 1-Hydroxypyrene: 18. min 5 ClinTox Complete Kit for 1-Hydroxypyrene in Urine for 1 assays HBM HPLC Parameters Pump 1: gradient pump, flow rates: 1., 1.5 ml/min Pump 2: isocratic pump: 1. ml/min Switching valve: 6-port/3-channel (order no. FK113) Injection volume: 25 μl Injection interval: 36 min Fluorescence detector: 242 nm (exc.), 388 nm (em.) HPLC-Thermostat: 3 C Kit Components (order no. 5): 57 Mobile Phase A 15 ml 58 Mobile Phase B 2 x 58 (2 x 2 ml) 59 SPE - Buffer 2 x 59 (2 x 25 ml) 9925 Urine Calibrator, lyophil. 5 x 5 ml 521 S Stabilising Reagent 2 ml 522 Enzyme Solution 1 ml Manual Quick Reference Start Accessories: 53 Analytical Column with test chromatogram FK7 manu-cart cartridge holder, one time accessory 1 set 531 SPE - Column 532 Guard Column 5 pcs. Sample Pretreatment Enzymatic hydrolysis: 2 ml urine 1. incubate (37 C, 2-36 h) 1 ml Stabilising Reagent S 2. centrifuge 1 μl Enzyme Solution Accessories: 54 Vials for Sample Pretreatment with Screw Cap, 1 ml 1 pcs. FK545 Sample loop, stainless steel, 5 μl FK581 PEEK-tubing (connection of prefilter and column) FK582 Stainless steel prefilter holder FK5821 Replacement filter for stainless steel prefilter holder 1 pcs. FK113 Switching valve, Sykam (6-port/3-channel) incl. electr. drive, steel FK3 Thermocult Incubator (37 C) Fully automated method On-Line Analysis: Inject 25 μl ClinChek Controls: 8925 Urine Control, lyophil., Level I, II 2 x 5 x 5 ml Recovery 1 % High analytical sensitivity 115

60 LC-MS/MS LC-MS/MS ClinMass Complete Kits ClinMass Optimisation Mixes and Internal Standards ClinMass LC-MS/MS Complete Kits are designed for a reliable and standardised analysis with tandem mass spectrometry. Similar to our HPLC complete kits, all components required for analysis are in clu - ded (with the exception of start accessories, optimisation mixes, accessories, and matrix controls). ClinMass Optimisation Mixes are applied to optimise the MS/MS parameters, as well as for the sub sequent check-up of the analytical system. ClinMass Internal Standards are used for the in - ternal standardisation of the LC-MS/MS analysis. These components are available for various parameters also as kit-independent ivd-reagents and can be used for the verification or implementation of inhouse methods. 117

61 Complete Kits LC-MS/MS ClinMass Complete Kits Alcoholism Ethylglucuronide and Ethylsulfate in Urine, Plasma and Serum Immunosuppressants Immunosuppressants in Whole Blood On-Line Analysis Immunosuppressants in Whole Blood, advanced On-Line Analysis Metabolic Disease Homocysteine in Plasma / Serum Homocysteine in Whole Blood (DBS) Psychoactive Drugs Benzodiazepines in Serum On-Line Analysis Vitamin Status Methylmalonic Acid in Serum / Plasma / Urine, advanced OH Vitamin D2 / D3 in Plasma and Serum On-Line Analysis

62 Ethylglucuronide (EtG) and ethylsulfate (EtS) are known as relatively new, specific parameters for the assessment of alcohol consumption, which dates back several days. The analysis is primarily performed from urine but may be extended to plasma and serum. For this purpose RECIPE offers a ClinMass Complete Kit for analysis from urine, which can be expanded to plasma and serum samples (ClinMass Supplement Kit, order no. MS81). The analytical method features fast and easy sample preparation and guarantees a reliable analyte determination. The kit validation was established in compliance with the German GTFCh guidelines for quality assurance. Alcoholism Ethylglucuronide and Ethylsulfate in Urine, Plasma and Serum Test Data (Urine) Linearity: EtG: μg/l EtS: μg/l LLOD: EtG: 45.7 μg/l / EtS: 13.1 μg/l LLOQ: EtG: 76.2 μg/l / EtS: 21.8 μg/l Intraassay precision: EtG: 5.3 % / EtS: 4.6 % Interassay precision: EtG: 5.4 % / EtS: 4.9 % Chromatogram of the ClinChek Urine Control, Level II (order no. MS881): Intensity (cps) d5-etg m/z: EtG m/z: Intensity (cps) 1.6e5 4.5 d5-ets 1.5e5 m/z: e5 1.3e5 1.2e5 1.1e5 1.e5 9.e4 8.e4 7.e4 6.e4 5.e4 4.e4 3.e4 2.e4 1.e EtS m/z: Complete Kits LC-MS/MS Parameters LC-Parameters HPLC pump: isocratic, flow rates:.2 ml/min,.5 ml/min Injection volume: 1 μl Injection interval: 5 min Column heater: 4 C MS-Parameters Ion source: ESI negative MS/MS-Mode: MRM MS8 ClinMass Complete Kit for Ethylglucuronide and Ethylsulfate in Urine for 4 assays Kit Components (order no. MS8): MS85 Autosampler Washing Solution 1 ml MS81 Mobile Phase 1 ml MS812 IS Internal Standard 4 x MS812 (4 x 1 ml) MS8713 Urine Calibrator Set, lyophil., Level x 1 x 1 ml Manual MS81 ClinMass Supplement Kit for Ethylglucuronide and Ethylsulfate in Plasma and Serum for 1 assays Sample Preparation A: Urine Dilution: 5 μl urine (calibrator, control, patient) LC-MS/MS Analysis: 1 μl Internal Standard IS Kit Components (order no. MS81): MS8112 IS Internal Standard 3 ml MS8113 Serum Calibrator Set, lyophil., Level x 1 x 1 ml MS8121 D Diluting Solution 5 ml Additional Components: MS814 Optimisation Mix 2 ml MS8413 Urine Calibrator Set, lyophil., Level x 1 x 1 ml First CE/IVD test kit for LC-MS/MS Fast and easy sample preparation Method validation according to GTFCh guidelines B: Plasma / Serum Precipitation: 1 μl sample (calibrator, control, patient) Dilution: 5 μl supernatant LC-MS/MS Analysis: Inject 1 μl Inject 1 μl 3 μl Internal Standard IS mix, centrifuge 5 μl Diluting Solution D Start Accessories: MS83 Analytical Column with test chromatogram ClinChek Controls: MS88 Urine Control, lyophil., Level I 1 x 1 ml MS881 Urine Control, lyophil., Level II 1 x 1 ml MS882 Urine Control, lyophil., Level III 1 x 1 ml MS883 Urine Control, lyophil., Level I, II, III 3 x 3 x 1 ml MS818 Serum Control, lyophil., Level I 1 x 1 ml MS8181 Serum Control, lyophil., Level II 1 x 1 ml MS8182 Serum Control, lyophil., Level I, II 2 x 5 x 1 ml 121

63 This ClinMass Complete Kit is designed for the therapeutic drug monitoring (TDM) of cyclosporine A, tacrolimus, sirolimus and everolimus. The sample preparation is based on a simple pretreatment step, followed by on-line analysis within a 2 min injection interval. A 4-Level and a 7-Level ClinCal Whole Blood Calibrator Set are provided for precise calibration and measurement. The calibration range may be optionally extended by use of an additional high calibration point. Available soon: Additional product for a fully automated sample preparation with liquid handling systems and well plates 4- and 7-Level calibrator set available Calibration range optionally extensible Controls available in five levels Immunosuppressants Immunosuppressants in Whole Blood On-Line Analysis Test Data Linearity (up to): 2 μg/l (Cyc), 8 μg/l (Tcr, Srl, Evr) LLOD:.11 μg/l (Cyc),.4 μg/l (Tcr),.73 μg/l (Srl),.126 μg/l (Evr) LLOQ:.37 μg/l (Cyc),.14 μg/l (Tcr),.244 μg/l (Srl),.42 μg/l (Evr) Intraassay precision: 2.3 % (Cyc), 4.8 % (Tcr), 4.8 % (Srl), 5. % (Evr) Interassay precision: 7.7 % (Cyc), 3.6 % (Tcr), 4.4 % (Srl), 4.1 % (Evr) LC-MS/MS Parameters LC-Parameters Pump 1: SPE-Buffer (.1 / 2.5 ml/min) Pump 2: Mobile Phase (.5 / 1. ml/min) Injection volume: 5 μl Injection interval: 2 min Switching valve: 6-port/3-channel (order no. FK112) Column heater: 6 C MS-Parameters Ion source: ESI positive MS/MS-Mode: MRM Sample Pretreatment Precipitation: 2 μl Precipitant P On-Line Analysis: 2 μl Internal Standard IS Inject 5 μl of the supernatant 1 μl whole blood (calibrator, control, patient) 1. mix and incubate (ambient temperature) 2. mix and centrifuge Chromatogram (left) and mass traces (right) of the ClinCal Whole Blood Calibrator for Immunosuppressants, Level 4, order no Intensity (cps) 1.7e4 1.6e4 1.5e4 1.4e4 1.3e4 1.2e4 1.1e4 1.e e4. 1.7e4. MS1 ClinMass Complete Kit for Immunosuppressants in Whole Blood for 4 assays Kit Components (order no. MS1): MS15 Autosampler Washing Solution 1 ml MS19 SPE - Buffer 2 x MS19 (2 x 1 ml) MS11 Mobile Phase 8 ml MS1212 IS Internal Standard, lyoph. (contains: Ascomycin, Cyclosporine D, d4-everolimus) 3 x MS1212 (3 x 3 ml) MS12 Sample Pretreatment Vials 4 x MS12 (4 x 1 pcs.) MS121 P Precipitant 8 ml Manual Additional Components: MS16 Reagent MP 8 ml MS114 Optimisation Mix 1, lyophil. 2 ml MS115 Optimisation Mix 2, lyophil. 3 ml 513 Whole Blood Calibrator, lyophil. (single point) 5 x 2 ml 928 Whole Blood Calibrator, lyophil. (additional level for order nos. 933 and 9933) 2 x 2 ml 933 Whole Blood Calibrator Set, lyophil., Level x 1 x 2 ml 9933 Whole Blood Calibrator Set, lyophil., Level x 1 x 2 ml Start Accessories: MS13 Analytical Column with test chromatogram MS131 SPE - Column MS132 Guard Column Holder incl. 1 Guard Column MS133 Guard Columns 5 pcs. FK74 Inline-Filter Accessories: FK112 Switching valve, Sykam (6-port/3-channel, incl. electr. drive, PEEK) FK733 Endfittings 2 pcs. FK734 Sealings and sieves 4 pcs. each FK735 Endstoppers 2 pcs. ClinChek Controls: 883 Whole Blood Control, lyophil., Level I 5 x 2 ml 8831 Whole Blood Control, lyophil., Level II 5 x 2 ml 8832 Whole Blood Control, lyophil., Level III 5 x 2 ml 8833 Whole Blood Control, lyophil., Level I, II, III 3 x 2 x 2 ml 893 Whole Blood Control, lyophil., Level IV, V 2 x 2 x 2 ml Intensity (cps) 1.6e e4..1 Ascomycin Tacrolimus (Tcr) d4-everolimus Sirolimus (Srl) Everolimus (Evr) Cyclosporine A (Cyc) Cyclosporine D m/z: m/z: m/z: m/z: m/z: m/z: m/z: Complete Kits 123

64 This ClinMass Complete Kit is an advancement of our reliable complete kit with order no. MS1 (see pages ) and provides an improved chromatographical performance. For analysis a new internal standard with the isotope labelled analytes d 12 -cy clo sporine A, 13 Cd 2 -tacrolimus, 13 Cd 3 -sirolimus und 13 C 2 d 4 -eve ro limus is available. Thus, matrix effects are excluded. As with our previous kit, the sample preparation is based on a simple pretreatment step, followed by on-line analysis within a 2 min injection interval. Available soon: Additional product for a fully automated sample preparation with liquid handling systems and well plates Internal standard containing isotope labelled analytes No matrix effects 4- and 7-Level calibrator set available Immunosuppressants Immunosuppressants in Whole Blood, advanced On-Line Analysis Test Data Linearity (up to): 2 μg/l (Cyc), 8 μg/l (Tcr, Srl, Evr) LLOD:.11 μg/l (Cyc),.4 μg/l (Tcr),.73 μg/l (Srl),.126 μg/l (Evr) LLOQ:.37 μg/l (Cyc),.14 μg/l (Tcr),.244 μg/l (Srl),.42 μg/l (Evr) Intraassay precision: 2.5 % (Cyc), 4.6 % (Tcr), 4.8 % (Srl), 4.9 % (Evr) Interassay precision: 6.5 % (Cyc), 4.2 % (Tcr), 4.4 % (Srl), 4.3 % (Evr) LC-MS/MS Parameters LC-Parameters Pump 1: SPE-Buffer (.1 / 2.5 ml/min) Pump 2: Mobile Phase (.5 / 1. ml/min) Injection volume: 5 μl Injection interval: 2 min Switching valve: 6-port/3-channel (order no. FK112) Column heater: 6 C MS-Parameters Ion source: ESI positive MS/MS-Mode: MRM Sample Pretreatment Precipitation: 2 μl Precipitant P On-Line Analysis: 2 μl Internal Standard IS Inject 5 μl of the supernatant 1 μl whole blood (calibrator, control, patient) 1. mix and incubate (ambient temperature) 2. mix and centrifuge Chromatogram (left) and mass traces (right) of the ClinCal Whole Blood Calibrator (order no. 9933), level 4 Intensity (cps) 5.9e5 5.5e5 5.e5 4.5e5 4.e5 3.5e5 3.e5 2.5e5 2.e5 1.5e5 1.e5 5.e Intensity (cps) 7.9e4 7.e4 6.e4 5.e4 4.e4 3.e4 2.e4 1.e4. 3.e4 2.8e4 2.4e4 2.e4 MS11 ClinMass Complete Kit, advanced, for Immunosuppressants in Whole Blood for 4 assays Kit Components (order no. MS11): MS15 Autosampler Washing Solution 1 ml MS19 SPE-Buffer 2 x MS19 (2 x 1 ml) MS11 Mobile Phase 8 ml MS1412 IS Internal Standard, lyophil. 3 x MS1412 (3 x 3 ml) MS12 Sample Pretreatment Vials 4 x MS12 (4 x 1 pcs.) MS121 P Precipitant 8 ml Manual Additional Components: MS16 Reagent MP 8 ml MS114 Optimisation Mix 1, lyophil. 2 ml MS1115 Optimisation Mix 2, lyophil. 2 ml 513 Whole Blood Calibrator, lyophil. (single point) 5 x 2 ml 928 Whole Blood Calibrator, lyophil. (additional level for order nos. 933 and 9933) 2 x 2 ml 933 Whole Blood Calibrator Set, lyophil. (Level - 3) 4 x 1 x 2 ml 9933 Whole Blood Calibrator Set, lyophil. (Level - 6) 7 x 1 x 2 ml Start Accessories: MS13 Analytical Column with test chromatogram MS131 SPE-Column MS132 Guard Column Holder incl. 1 Guard Column MS133 Guard Column 5 pcs. FK74 Inline-Filter (stainless steel sieve, free of dead volume) Accessories: FK112 Switching valve Sykam (6-port/3-channel incl. electr. drive, PEEK) FK733 Endfittings 2 pcs. FK734 Sealings and sieves 4 pcs. each FK735 Endstoppers 2 pcs. ClinChek Controls: 883 Whole Blood Control, lyophil., Level I 5 x 2 ml 8831 Whole Blood Control, lyophil., Level II 5 x 2 ml 8832 Whole Blood Control, lyophil., Level III 5 x 2 ml 8833 Whole Blood Control, lyophil., Level I, II, III 3 x 2 x 2 ml 893 Whole Blood Control, lyophil., Level IV, V 2 x 2 x 2 ml Tacrolimus 13 Cd 2 -Tacrolimus m/z: Everolimus 13 C 2 d 4 -Everolimus 3.1e4 2.8e4 2.4e4 2.e4 1.6e4 1.2e e5 5.e5 4.e5 1.6e4 m/z: 3.e5 1.2e e e Sirolimus 13 Cd 3 -Sirolimus m/z: Cyclosporine A d 12 -Cyclosporine A m/z: Complete Kits 125

65 Homocysteine is an established parameter for the risk assessment of degenerative vascular diseases, which may lead to heart attack, stroke and thrombosis. The RECIPE ClinMass Complete Kit allows a reliable determination of total homocysteine for the detection of hyperhomocysteinemia. After an easy sample preparation (reduction and precipitation step) the samples are analysed with an injection interval of 1. min only. Optionally, the sample preparation can be performed fully automated with liquid handling systems and 96-well plates. Metabolic Disease Homocysteine in Plasma / Serum Test Data Linearity:.1-16 μmol/l LLOD:.1 μmol/l LLOQ:.1 μmol/l Intraassay precision: 1.9 % Interassay precision: 4.8 % Chromatogram (left) and mass traces (right) of the ClinCal Serum Calibrator, Level 3 (order no. MS213) Intensity (cps) 4.8e5 4.6e5 4.4e5 4.2e5 4.e5 3.8e5 3.6e5 3.4e5 3.2e5 3.e5 2.8e5 2.6e5 2.4e5 2.2e5 2.e5 1.8e5 1.6e5 1.4e5 1.2e5 1.e5 8.e4 6.e4 4.e4 2.e Intensity (cps) 4.e5 3.5e5 3.e5 2.5e5 2.e5 1.5e5 1.e5 5.e4. 3.e5 2.5e5 2.e5 1.5e5 1.e5 5.e Homocysteine m/z: d4-homocysteine m/z: Complete Kits LC-MS/MS Parameters LC-Parameters Pump: isocratic (.7 ml/min) Injection volume: 1 μl Injection interval: 1. min Column heater: room temperature Order No. Description MS2 ClinMass Complete Kit for Homocysteine in Plasma / Serum for 3 assays MS-Parameters Ion source: MS/MS-Mode: Sample Preparation Reduction: 5 μl sample (+ 5 μl Internal Standard IS) Precipitation: ESI, positive MRM 2 μl Reagent B 5 μl Reagent A mix, incubate (room temperature, 5 min) Kit Components (order no. MS2): MS25 Autosampler Washing Solution 1 ml MS21 Mobile Phase 8 ml MS212 IS Internal Standard, lyophil. 3 x MS212 (3 x 5 ml) MS213 Serum Calibrator Set, lyophil. (Level - 3) 4 x 1 x 1 ml MS22 Sample Preparation Vials 3 x MS22 (3 x 1 pcs.) MS221 Reagent A 3 x MS221 (3 x 5 ml) MS222 Reagent B 2 x MS222 (2 x 3 ml) Manual Start Accessories: MS23 Analytical Column with test chromatogram Accessories: FK65 Protective sheets for 96-well-plate (aluminium foil, 8 x 14 mm) 1 pcs. FK Well-Plates (37 μl) 5 pcs. FK Well-Plates (12 μl) 5 pcs. Simple and quick two-step sample preparation LC-MS/MS Analysis: Inject 1 μl of the supernatant 1. mix, incubate (4 C, 5 min) 2. centrifuge ClinChek Controls: 238 Plasma Control, lyophil., Level I 1 x 3 ml 2381 Plasma Control, lyophil., Level II 1 x 3 ml 2382 Plasma Control, lyophil., Level I, II 2 x 5 x 3 ml Injection interval: 1. min Optional: method with automated sample preparation (96-well plates) 127

66 The determination of homocysteine from dried blood spots (DBS) is used for the newborn screening for inherited defects of the methionine metabolism (homocystinuria). The RECIPE ClinMass Com plete Kit allows a reliable determination of total homocys - teine from filter spots. The easy sample preparation (reduction and precipitation step) is followed by the sample analysis with an injection interval of 1. min only. For blood collection suitable filter test cards are available. Optionally, the sample preparation can be performed fully automated with liquid handling systems and 96-well plates. Metabolic Disease Homocysteine in Whole Blood (DBS) Test Data Linearity:.2-14 μmol/l LLOD:.7 μmol/l LLOQ:.2 μmol/l Intraassay precision: 2.8 % Interassay precision: 3.8 % Chromatogram (left) and mass traces (right) of the ClinCal Whole Blood Calibrator (DBS), Level 3 (order no. MS2113) Intensity (cps) 2.5e4 2.4e4 2.3e4 2.2e4 2.1e4 2.e4 1.9e4 1.8e4 1.7e4 1.6e4 1.5e4 1.4e4 1.3e4 1.2e4 1.1e4 1.e Intensity (cps) 2.5e4 2.1e4 1.8e4 1.5e4 1.2e e4 2.1e4 1.8e4 1.5e4 1.2e Homocysteine m/z: d4-homocysteine m/z: Complete Kits LC-MS/MS Parameters LC-Parameters Pump: isocratic (.7 ml/min) Injection volume: 1 μl Injection interval: 1. min Column heater: room temperature MS21 ClinMass Complete Kit for Homocysteine in Whole Blood (DBS) for 3 assays MS-Parameters Ion source: MS/MS-Mode: Sample Preparation Reduction: Filter Spot Sample (+ 15 μl Internal Standard) Precipitation: ESI, positive MRM mix 1 μl Reagent B 15 μl Reagent A Kit Components (order no. MS21): MS25 Autosampler Washing Solution 1 ml MS21 Mobile Phase 8 ml MS2112 IS Internal Standard, lyophil. 5 ml MS2113 Whole Blood Calibrator Set (filter spots, Level - 3) 4 x 1 x 3 spots MS22 Sample Preparation Vials 3 x MS22 (3 x 1 pcs.) MS221 Reagent A 5 ml MS222 Reagent B 3 ml Manual Start Accessories: MS23 Analytical Column with test chromatogram Accessories: FK65 Protective sheets for 96-well-plate (aluminium foil, 8 x 14 mm) 1 pcs. FK Well-Plates (37 μl) 5 pcs. MS217 Filter Testcards 1 pcs. Simple and quick two-step sample preparation LC-MS/MS Analysis: 1. mix 2. centrifuge Inject 1 μl of the supernatant ClinChek Controls: MS2182 Whole Blood Control (filter spots), Level I, II 2 x 1 x 3 spots Injection interval: 1. min Optional: method with automated sample preparation (96-well plates) 129

67 Benzodiazepines are a class of psychoactive drugs, which are widely prescribed to treat conditions such as anxiety and insomnia. The chronic administration of benzodiazepines may require therapeutic drug moni - toring. For this purpose, the ClinMass Complete Kit allows for the routine analysis of 33 different benzodiazepines and metabolites. No manual sample preparation is required. The serum sample is directly injected; the Internal Standard IS added by an autosampler injector program and the sample preparation performed on-line by solid phase extraction (SPE). The entire run time is 11 minutes, including sample clean-up, LC-MS/MS analysis and column regeneration, enabled by automated column switching. Psychoactive Drugs Benzodiazepines in Serum On-Line Analysis Test Data Test data are available on request. LC-MS/MS Parameters LC-Parameters Isocratic HPLC pump: SPE Buffer (.1 / 1.5 / 5. ml/min) Binary HPLC pump: Mobile Phases A/B (.7 ml/min) Injection volume: 2 μl Injection interval: 11 min Switching valve: 6-port/3-channel (order no. FK113) Column heater: 3 C MS-Parameters Ion source: Heated Nebulizer (APcI), positive MS/MS mode: MRM Chromatogram of the ClinCal Serum Calibrator, Level 1 (order no. MS613) Intensity (cps) 5.1e5 3.e5 2.8e5 2.6e5 2.4e5 2.2e5 2.e5 1.8e5 1.6e5 1.4e5 1.2e5 1.e5 8.e4 6.e4 4.e4 2.e Aminoclonazepam Aminonitrazepam Aminoflunitrazepam 4.13 Zaleplon 4.86 Demoxepam 5.12 Bromazepam 5.27 Desmethylflunitrazepam 5.27 Norclobazam 5.43 α-oh-triazolam 5.44 Clonazepam 5.59 Flunitrazepam 5.64 Nitrazepam 5.66 α-oh-alprazolam 5.75 Estazolam 5.81 Clobazam 5.86 Triazolam 6.1 Lorazepam 6.13 Alprazolam 6.21 Oxazepam 6.23 Desalkylflurazepam 6.54 Zolpidem 6.56 Temazepam 6.64 α-oh-midazolam 6.81 Lormetazepam 6.84 Chlordiazepoxide 7.21 Nordiazepam 7.51 Midazolam 7.93 Diazepam 7.98 Flurazepam 8.55 Trazodone 8.74 Tetrazepam 9.19 Prazepam 9.23 Medazepam 9.67 MS6 ClinMass Complete Kit for Benzodiazepines in Serum for 2 assays Kit Components (order no. MS6): MS65 Autosampler Washing Solution 1 ml MS67 Mobile Phase A 1 ml MS68 Mobile Phase B 1 ml MS69 SPE - Buffer 2 x MS69 (2 x 1 ml) MS612 IS Internal Standard, lyophil. 5 x MS612 (5 x 2 ml) MS613 Serum Calibrator Set, lyophil., Level x 1 x 1 ml Manual Complete Kits On-Line Analysis Injection of 1 μl sample + 1 μl Internal Standard IS* * contains 2 isotope labeled compounds Additional Components MS615 - MS619 Optimisation Mix 1-5, lyophil. 2 ml, each Start Accessories: MS63 Analytical Column with test chromatogram MS631 SPE - Column MS632 Guard Column Holder incl. 1 Guard Column MS633 Guard Column 5 pcs. FK74 Inline-Filter (stainless steel sieve, free of dead volume) Quantification of 33 analytes Accessories: FK113 Switching valve, Sykam (6-port/3-channel incl. electr. drive, steel) FK733 Endfittings 2 pcs. FK734 Sealings and sieves 4 pcs., each FK735 Endstoppers 2 pcs. On-line sample preparation ClinChek Controls: MS682 Serum Control, lyophil., Level I, II 2 x 5 x 1 ml Injection interval: 11 min 131

68 Methylmalonic acid (MMA) serves for the assess ment of the vitamin B12 status. Vitamin B12 deficiency leads to an increased MMA concentration in serum, plasma and urine. This new RECIPE ClinMass Complete Kit provides a fast and time saving MMA analysis featu ring short sample preparation with only one pipet ting step (serum, plas ma) or direct injection of samples after dilution and addition of IS (urine). The subsequent LC-MS/MS analysis is per - formed within a 2 min injection interval only while the iso - bar component succinic acid, which may inter fere with MMA, is separated reliably. Cali bra tion and qua lity control is per formed in a convenient and cost- efficient way. The method is fully validated using only one (se rum) cali - bration and control set for all three sample matrices (Clin Cal 4-Level Cali brator Set and ClinChek Controls). Vitamin Status Methylmalonic Acid in Serum / Plasma / Urine, advanced Test Data Linearity: Serum, Plasma: nmol/l Urine: nmol/l LLOD: Serum, Plasma: 15 nmol/l Urine: 391 nmol/l LLOQ: Serum, Plasma: 25 nmol/l Urine: 651 nmol/l Intraassay precision: 4.3 % Interassay precision: 5.1 % Chromatogram of the ClinChek Serum Control, Level I (order no. MS58) Intensity (cps) 1.2e e4 Succinic Acid d3-methylmalonic Acid m/z: Methylmalonic Acid m/z: MS51 ClinMass Complete Kit, advanced, for Methylmalonic Acid in Serum / Plasma / Urine for 3 assays Complete Kits One-step sample preparation (serum / plasma) LC-MS/MS Parameters LC-Parameters Binary gradient pump: Mobile Phase A / B (.7 ml/min) Injection volume: 2-5 μl Injection interval: 2. min Column heater: 25 C MS-Parameters Ion source: Turbo-ionspray (TIS) ESI, negative MS/MS-Mode: MRM Sample Preparation Precipitation / Addition of IS: 4 μl P Precipitant (contains internal standard) 1 μl sample* (calibrator, control, patient) Kit Components (order no. MS51): MS55 Autosampler Washing Solution 1 ml MS518 Mobile Phase A 1 ml MS519 Mobile Phase B 2 ml MS5112 P Precipitant with Internal Standard 3 x MS5112 (3 x 4 ml) MS513 Serum Calibrator Set, lyophil., (Level - 3) 4 x 1 x 2 ml MS52 Sample Preparation Vials 3 x MS52 (3 x 1 pcs.) Manual Additional Components: MS5114 Optimisation Mix 2 ml MS521 D Diluting Solution for Urine 5 ml Start Accessories: MS513 Analytical Column with test chromatogram ClinChek Controls: MS58 Serum Control, lyophil., Level I 1 x 2 ml MS581 Serum Control, lyophil., Level II 1 x 2 ml MS582 Serum Control, lyophil., Level I, II 2 x 5 x 2 ml LC-MS/MS Analysis: mix and centrifuge Reliable separation of succinic acid Inject 2-5 μl of the sample * Urines are diluted (5 μl urine + 1 μl Diluting Solution D) Injection interval: 2 min 133

69 This ClinMass LC-MS/MS Complete Kit enables a fast on-line analysis of 25-OH vitamin D (D2, D3) with an Vitamin Status 25-OH-Vit D2 25-OH-Vit D3 d6-25-oh-vit D3 injection interval of 3 min only. In order to avoid false high analytical values, the C-3 epimer of 25-OH vitamin D3 (3-epi-25-OH vitamin D3) is separated reliably from the analyte peak. An analytical column with a run time of 4 min (order no. MS735) is additio nally avail - able in order to obtain base line separation. 25-OH Vitamin D2 / D3 in Plasma and Serum On-Line Analysis Intensity (cps) Intensity (%) 1 1 MS73 Vit D3 3-epi Vit D MS735 Vit D3 Available soon: Additional product for a fully automated sample preparation with liquid handling systems and well plates Test Data Linearity: μg/l (D2) μg/l (D3) LLOD:.4 μg/l (D2).7 μg/l (D3) LLOQ: 1.4 μg/l (D2) 2.3 μg/l (D3) Intraassay precision: 6.8 % (D2) 4.7 % (D3) left: right: ClinCal Serum Calibrator, order no. MS713, level 2 (25-OH vitamin D2 and D3) and ClinMass Internal Standard, order no. MS712 (d6-25-oh vitamin D3) Human serum with 25-OH vitamin D3 and 3-epi-25-OH vitamin D3, measured with the 3-min method (top) and 4-min method (bottom) epi Vit D Complete Kits Interassay precision: 7.6 % (D2) 6.6 % (D3) Fast on-line analysis (injection interval: 3 min) Separation of the C-3 epimer Traceable to NIST standard SRM 972a LC-MS/MS Parameters LC-Parameters Pump 1: SPE-Buffer (.1-5. ml/min) Pump 2: Mobile Phase (.5 ml/min) Injection volume: 1-5 μl Injection interval: 3 min (4 min) Switching valve: 6-port/3-channel (order no. FK112) Column heater: 4 C MS-Parameters Ion source: Heated Nebulizer (APcI), positive MS/MS-Mode: MRM Sample Pretreatment Precipitation: 15 μl mixture IS/P On-Line Analysis: Inject 1-5 μl 5 μl sample (calibrator, control, patient) 1. mix, incubate (4 C) 2. mix, centrifuge MS7 ClinMass Complete Kit for 25-OH Vitamin D2 / D3 in Plasma and Serum for 3 assays Kit Components (order no. MS7): MS75 Autosampler Washing Solution 1 ml MS79 SPE-Buffer 2 x MS79 (2 x 1 ml) MS71 Mobile Phase 7 ml MS712 IS Internal Standard 3 ml MS713 Serum Calibrator Set, lyophil. (Level - 3) 4 x 1 x 1 ml MS72 Sample Pretreatment Vials 3 x MS72 (3 x 1 pcs.) MS721 P Precipitant 15 ml Manual Additional Components: MS714 Optimisation Mix 2 ml MS715 Optimisation Mix 3-epi 1 ml Start Accessories: MS73 Analytical Column with test chromatogram MS735 Analytical Column 3-epi with test chromatogram (for the additional analysis of 3-epi-25-OH Vitamin D3) MS731 SPE-Column FK74 Inline-Filter (stainless steel sieve, free of dead volume) Accessories: FK112 Switching valve Sykam (6-port/3-channel incl. electr. drive, PEEK) FK733 Endfittings 2 pcs. FK734 Sealings and sieves 4 pcs. each FK735 Endstoppers 2 pcs. ClinChek Controls: MS78 Serum Control, lyophil., Level I 1 x 1 ml MS781 Serum Control, lyophil., Level II 1 x 1 ml MS782 Serum Control, lyophil., Level I, II 2 x 5 x 1 ml 135

70 LC-MS/MS Opti Mix, IS ClinMass Optimisation Mixes ClinMass Internal Standards

71 Product Survey, Optimisation Mixes Antiretrovirals Amprenavir, atazanavir, darunavir, delavirdine, efavirenz, etravirine, indinavir, lopinavir, maraviroc, nelfinavir, nevirapine, raltegravir, ritonavir, saquinavir, tipranavir MS414 ClinMass Optimisation Mix, ready for use, for Antiretrovirals 2 ml Immunosuppressants Cyclosporine A, everolimus, sirolimus, tacrolimus MS114 ClinMass Optimisation Mix 1, lyophil., for Immunosuppressants 2 ml (for ClinMass Complete Kits with order nos. MS1 and MS11) Benzodiazepines 7-Aminoflunitrazepam, 7-aminonitrazepam, demoxepam, flunitrazepam, prazepam, temazepam MS615 ClinMass Optimisation Mix 1, lyophil., for Benzodiazepines 2 ml Bromazepam, clobazam, lormetazepam, nitrazepam, norclobazam, nordiazepam MS616 ClinMass Optimisation Mix 2, lyophil., for Benzodiazepines 2 ml Ascomycin, cyclosporine D, d4-everolimus MS115 ClinMass Optimisation Mix 2, lyophil., for Immunosuppressants 3 ml (for ClinMass Complete Kit with order no. MS1) d12-cyclosporine A, 13 C2d4-everolimus, 13 Cd3-sirolimus, 13 Cd2-tacrolimus MS1115 ClinMass Optimisation Mix 2, lyophil., for Immunosuppressants 2 ml (for ClinMass Complete Kit with order no. MS11) Opti Mix, IS Alprazolam, 7-aminoclonazepam, clonazepam, α-hydroxymidazolam, medazepam, midazolam, norflunitrazepam, tetrazepam MS617 ClinMass Optimisation Mix 3, lyophil., for Benzodiazepines 2 ml Chlordiazepoxide, desalkylflurazepam, diazepam, flurazepam, α-hydroxyalprazolam, trazodone, zolpidem MS618 ClinMass Optimisation Mix 4, lyophil., for Benzodiazepines 2 ml Estazolam, α-hydroxytriazolam, lorazepam, oxazepam, triazolam, zaleplone MS619 ClinMass Optimisation Mix 5, lyophil., for Benzodiazepines 2 ml (Order nos. MS615 - MS619: for ClinMass Complete Kit with order no. MS6) Methylmalonic Acid Methylmalonic acid, d3-methylmalonic acid MS5114 ClinMass Optimisation Mix, ready for use, for Methylmalonic Acid 2 ml (for ClinMass Complete Kit with order no. MS51) 25-OH Vitamin D2 / D3 25-Hydroxy-vitamin D2, 25-hydroxy-vitamin D3, d6-25-hydroxy-vitamin D3 MS714 ClinMass Optimisation Mix, ready for use, for 25-OH Vitamin D2 / D3 2 ml 25-Hydroxy-vitamin D3, 3-epi-25-hydroxy-vitamin D3 MS715 ClinMass Optimisation Mix, ready for use, for 25-OH Vitamin D3 1 ml and C-3 Epimer Ethylglucuronide Ethylglucuronide, d5-ethylglucuronide, ethylsulfate, d5-ethylsulfate MS814 ClinMass Optimisation Mix, ready for use, for Ethylglucuronide 2 ml (for ClinMass Complete Kit with order no. MS8/MS81) (Order nos. MS714 - MS715: for ClinMass Complete Kit with order no. MS7)

72 Product Survey, Internal Standards Antiretrovirals d4-amprenavir, d5-atazanavir, d9-darunavir, d4-efavirenz, d8-etravirine, d6-indinavir, d8-lopinavir, d6-maraviroc, d3-nelfinavir, d5-nevirapine, d3-raltegravir, d6-ritonavir, d6-saquinavir, d4-tipranavir MS412 ClinMass Internal Standard, ready for use, for Antiretrovirals 2 ml Benzodiazepines d5-alprazolam, d4-7-aminoclonazepam, d7-7-aminoflunitrazepam, d5-chlordiazepoxide, d4-clonazepam, d5-diazepam, d5-estazolam, d7-flunitrazepam, d5-α-hydroxyalprazolam, d4-α-hydroxymidazolam, d4-α-hydroxytriazolam, d4-lorazepam, d4-midazolam, d5-nitrazepam, d5-nordiazepam, d5-oxazepam, d5-prazepam, d5-temazepam, d4-triazolam, d6-zolpidem MS612 ClinMass Internal Standard, lyophil., for Benzodiazepines 2 ml (for ClinMass Complete Kit with order no. MS6) Ethylglucuronide d5-ethylglucuronide, d5-ethylsulfate MS812 ClinMass Internal Standard, ready for use, for Ethylglucuronide 1 ml (for ClinMass Complete Kit with order no. MS8) MS8112 ClinMass Internal Standard, ready for use, for Ethylglucuronide 3 ml (for ClinMass Complete Kit with order no. MS81) Immunosuppressants Cyclosporine D MS1112 ClinMass Internal Standard, lyophil., for Immunosuppressants 25 μg Ascomycin, cyclosporine D, d4-everolimus MS1212 ClinMass Internal Standard, lyophil., for Immunosuppressants 3 ml (for ClinMass Complete Kit with order no. MS1) d12-cyclosporine A, 13 C2d4-everolimus, 13 Cd3-sirolimus, 13 Cd2-tacrolimus MS1312 ClinMass Internal Standard, lyophil., for Immunosuppressants 6.25 /.5 /.5 /.5 μg d12-cyclosporine A, 13 C2d4-everolimus, 13 Cd3-sirolimus, 13 Cd2-tacrolimus MS1412 ClinMass Internal Standard, lyophil., for Immunosuppressants 3 ml (for ClinMass Complete Kit with order no. MS11) Methylmalonic Acid d3-methylmalonic acid MS5112 ClinMass Internal Standard, lyophil., for Methylmalonic Acid 4 ml (in Precipitant, for ClinMass Complete Kit with order no. MS51) Opti Mix, IS Homocysteine d8-homocystine MS212 ClinMass Internal Standard, lyophil., for Homocysteine 5 ml (for ClinMass Complete Kit with order no. MS2) MS2112 ClinMass Internal Standard, lyophil., for Homocysteine 5 ml (for ClinMass Complete Kit with order no. MS21) Immunosuppressants Ascomycin MS112 ClinMass Internal Standard, lyophil., for Immunosuppressants 2 μg Nicotine and Metabolites d3-cotinine, d3-hydroxycotinine, d3-nicotine MS312 ClinMass Internal Standard, ready for use, for Nicotine and Metabolites 1.5 ml 25-OH Vitamin D2 / D3 d6-25-hydroxy-vitamin D3 MS712 ClinMass Internal Standard, ready for use, for 25-OH Vitamin D2 / D3 3 ml (for ClinMass Complete Kit with order no. MS7) MS7112 ClinMass Internal Standard, lyophil., for 25-OH Vitamin D2 / D3 2 μg

73 Quality Assurance ClinTest Solutions ClinCal Calibrators ClinChek Controls Quality Assurance RECIPE provides a wide range of IVD/CE labelled test and reference materials. Our products help to ensure a coherent QA process including the tes - ting of the analytical system (ClinTest ), calibration (ClinCal ) and quality control (ClinChek ). ClinTest Standard and Test Solutions are matrixfree and thus are ready to use. ClinCal Cali bra tors and ClinChek Controls are available in different matrices (urine, plasma, serum, whole blood) and are prepared for analysis like the patient samples. Datasheet updates available: 143

74 Quality Assurance ClinTest Solutions ClinTest 145

75 ClinTest Standard and Test Solutions Amiodarone Amiodarone, desethylamiodarone, internal standard 211 ClinTest Standard Solution, ready for use, for Amiodarone 1 x 3 ml Atypical Neuroleptics Clozapine, desmethylclozapine, desmethylolanzapine, internal standard, olanzapine, quetiapine 414 ClinTest Test Solution, lyophil., for Atypical Neuroleptics 5 x 2 ml Antiasthmatics Caffeine, internal standard, theobromine, theophylline 1211 ClinTest Standard Solution, ready for use, for Antiasthmatics 1 x 4 ml Paliperidone (9-OH-risperidone), risperidone 4114 ClinTest Test Solution, ready for use, for Risperidone, Paliperidone 1 x 15 ml Antiepileptics Carbamazepine, carbamazepine-epoxide, N-desmethylmethsuximide, ethosuximide, 1-hydroxy-carbamazepine, internal standard, oxcarbazepine, PEMA, phenobarbital, phenytoin, primidone 1511 ClinTest Standard Solution, ready for use, Antiepileptics 1 x 3 ml Carbamazepine, carbamazepine-epoxide, ethosuximide, internal standard, 1-hydroxy-carbamazepine, lamotrigine, oxcarbazepine, phenobarbital, phenytoin, primidone, sulthiame 1411 ClinTest Standard Solution, ready for use, Antiepileptics 3 1 x 3 ml N-Desmethylmethsuximide, felbamate, internal standard, lacosamide, rufinamide, zonisamide ClinTest Standard Solution, ready for use, Antiepileptics 4 1 x 3 ml Basic Drugs (TOX.I.S. TM ) 6-Acetylmorphine, amphetamine, codeine, EDDP, internal standard, MDA, methadone, morphine, tilidine 614 ClinTest TOX.I.S. TM Test Solution, ready for use, for Basic Drugs in Urine 1 x 15 ml β-carotene See title 314 ClinTest Test Solution, lyophil., for β-carotene 1 x 3 ml Catecholamines Dopamine, epinephrine, internal standard, norepinephrine 111 ClinTest Standard Solution, ready for use, for Catecholamines 1 x 1 ml in Plasma 211 ClinTest Standard Solution, ready for use, for Catecholamines 1 x 1 ml in Urine ClinTest CDT A-, mono-, di-, tri-, tetra-, penta-, hexasialotransferrin 2114 ClinTest Test Solution, ready for use, for CDT 1 x 15 ml

76 ClinTest Standard and Test Solutions Coenzyme Q1 Coenzyme Q1 (ubiquinone), internal standard 3114 ClinTest Test Solution, ready for use, for Coenzyme Q1 1 x 3 ml Lamotrigine and Sulthiame Internal standard 1, internal standard 2, lamotrigine, sulthiame ClinTest Standard Solution, ready for use, 1 x 3 ml for Lamotrigine and Sulthiame Hemoglobin A1c See title 1111 ClinTest Reference Standard, ready for use, for HbA1c 1 x 5 ml Levetiracetam (Keppra ) Internal standard, levetiracetam ClinTest Standard Solution, ready for use, for Levetiracetam 1 x 3 ml Hemoglobin Variants Hemoglobin A, A1c, A2, C, D, E, F, S ClinTest Test Solution, ready for use, for Hemoglobin Variants 5 x 3 ml Metanephrines Internal standard, metanephrine, 3-methoxytyramine, normetanephrine 411 ClinTest Standard Solution, ready for use, for Metanephrines 1 x 1 ml ClinTest Hippuric Acids Hippuric acid, internal standard, m-methyl-hippuric acid, o-methyl-hippuric acid 5211 ClinTest Standard Solution, ready for use, for Hippuric Acids 1 x 3 ml t,t-muconic Acid Internal standard, t,t-muconic acid 5111 ClinTest Standard Solution, ready for use, for t,t-muconic Acid 1 x 3 ml Homocysteine Cysteine, cysteinylglycine, homocysteine, internal standard 2311 ClinTest Standard Solution, ready for use, for Homocysteine 1 x 3 ml Mycophenolic Acid Internal standard, mycophenolic acid 2914 ClinTest Test Solution, ready for use, for Mycophenolic Acid 1 x 3 ml Hydroxyproline Hydroxyproline, internal standard 1611 ClinTest Standard Solution, ready for use, for Hydroxyproline 1 x 5 ml Pharmaceuticals (TOX.I.S. TM ) Carbamazepine, doxepin, doxylamine, internal standard, norclozapine, oxazepam, temazepam 6114 ClinTest TOX.I.S. TM Test Solution, ready for use, for Pharmaceuticals 1 x 15 ml

77 ClinTest Standard and Test Solutions Porphyrins Coproporphyrin I, coproporphyrin III, heptacarboxyporphyrin I, hexacarboxyporphyrin I ab, hexacarboxyporphyrin I ac, internal standard, pentacarboxyporphyrin I, uroporphyrin I 1711 ClinTest Standard Solution, ready for use, for Porphyrins 1 x 5 ml Vitamin C See title 2814 ClinTest Test Solution, lyophilised, for Vitamin C 5 x 1 ml Serotonin Internal standard, serotonin 6711 ClinTest Standard Solution, lyophilised, for Serotonin 5 x 2 ml 25-OH Vitamin D2 / D3 Internal standard, 25-hydroxy vitamin D2, 25-hydroxy vitamin D ClinTest Test Solution, lyophilised, for 25-hydroxy Vitamin D2 / D3 2 x 2 ml Vitamin A and E Internal standard, vitamin A, vitamin E 2211 ClinTest Standard Solution, ready for use, for Vitamin A and E 1 x 3 ml VMA, HVA, and 5-HIAA Homovanillic acid (HVA), 5-hydroxyindoleacetic acid (5-HIAA), internal standard, vanillylmandelic acid (VMA) 311 ClinTest Standard Solution, lyophilised, for VMA/HVA/5-HIAA 5 x 1 ml ClinTest Vitamin B1 Thiamine, thiaminemonophosphate (TMP), thiaminepyrophosphate (TPP) 2414 ClinTest Test Solution, ready for use, for Vitamin B1 1 x 3 ml Vitamin B2 Flavin adenine dinucleotide (FAD), flavin mononucleotide (FMN), riboflavin 2514 ClinTest Test Solution, lyophilised, for Vitamin B2 5 x 2 ml Vitamin B6 Pyridoxal, Pyridoxal-5-phosphate 2611 ClinTest Standard Solution, ready for use, for Vitamin B6 1 x 3 ml

78 Quality Assurance ClinCal Calibrators Analyte Survey Product Survey Urine Calibrators Plasma Calibrators Serum Calibrators Whole Blood Calibrators ClinCal 153

79 Analyte Survey With ClinCal Calibrator Materials the following analytes are available: Analyte Matrix ClinCal Calibrator Order No. Page Analyte Matrix ClinCal Calibrator Order No. Page (alphabetical) Urine Plasma Serum Whole = available Blood = in preparation (alphabetical) Urine Plasma Serum Whole = available Blood = in preparation 5-ALA (5-Aminolevulinic acid) ClinCal 5-ALA, PBG ClinCal Porphyrins Alanine ClinCal Amino Acids Alprazolam ClinCal Benzodiazepines MS Aluminium ClinCal Trace Elements α-aminoabutyric acid ClinCal Amino Acids Aminoclonazepam ClinCal Benzodiazepines MS Aminoflunitrazepam ClinCal Benzodiazepines MS Aminolevulinic acid (5-ALA) ClinCal 5-ALA, PBG ClinCal Porphyrins Aminonitrazepam ClinCal Benzodiazepines MS Amiodarone ClinCal Amiodarone Amisulpride ClinCal Psychoactive Drugs TDM Amitriptyline ClinCal Psychoactive Drugs TDM ClinCal Tricyclic Antidepressants MS Amprenavir ClinCal Antiretrovirals MS Antimony ClinCal Trace Elements Arginine ClinCal Amino Acids Aripiprazole ClinCal Psychoactive Drugs TDM ClinCal Psychoactive Drugs TDM Arsenic ClinCal Trace Elements Ascorbic acid (Vitamin C) ClinCal Vitamin C Asparagine ClinCal Amino Acids Aspartic acid ClinCal Amino Acids Atazanavir ClinCal Antiretrovirals MS Barium ClinCal Trace Elements Beryllium ClinCal Trace Elements Bismuth ClinCal Trace Elements Bisphenol A ClinCal Phenolic Compounds Bromazepam ClinCal Benzodiazepines MS Bromide ClinCal Antiepileptics Bupropion ClinCal Psychoactive Drugs TDM Butoxy acetic acid ClinCal Occupational Medicine Cadmium ClinCal Trace Elements Caffeine ClinCal Antiasthmatics Carbamazepine ClinCal Antiepileptics ClinCal Antiepileptics Carbamazepine-epoxide ClinCal Antiepileptics ClinCal Antiepileptics β-carotene ClinCal β-carotene Chlordiazepoxide ClinCal Benzodiazepines MS Chromium ClinCal Trace Elements Citalopram ClinCal Psychoactive Drugs TDM ClinCal Psychoactive Drugs TDM Citrulline ClinCal Amino Acids Clobazam ClinCal Benzodiazepines MS Clomipramine ClinCal Psychoactive Drugs TDM ClinCal Tricyclic Antidepressants MS Clonazepam ClinCal Benzodiazepines MS Clozapine ClinCal Atypical Neuroleptics ClinCal Psychoactive Drugs TDM ClinCal Psychoactive Drugs TDM ClinCal Tricyclic Antidepressants MS ClinCal

80 Analyte Survey With ClinCal Calibrator Materials the following analytes are available: Analyte Matrix ClinCal Calibrator Order No. Page Analyte Matrix ClinCal Calibrator Order No. Page (alphabetical) Urine Plasma Serum Whole = available Blood = in preparation (alphabetical) Urine Plasma Serum Whole = available Blood = in preparation Cobalt ClinCal Trace Elements Coenzyme Q1 (Ubiquinone) ClinCal Coenzyme Q Copper ClinCal Trace Elements Coproporphyrin I ClinCal Porphyrins Coproporphyrin III ClinCal Porphyrins Cotinine ClinCal Nicotine and Metabolites MS o-cresol ClinCal Phenolic Compounds Cyclosporine A ClinCal Immunosuppressants Darunavir ClinCal Antiretrovirals MS Delavirdine ClinCal Antiretrovirals MS Demoxepam ClinCal Benzodiazepines MS Desalkylflurazepam ClinCal Benzodiazepines MS Desethylamiodarone ClinCal Amiodarone Desipramine ClinCal Psychoactive Drugs TDM ClinCal Tricyclic Antidepressants MS Desmethylclozapine ClinCal Atypical Neuroleptics (Norclozapine) ClinCal Psychoactive Drugs TDM ClinCal Psychoactive Drugs TDM ClinCal Tricyclic Antidepressants MS Desmethylfluoxetine ClinCal Psychoactive Drugs TDM N-Desmethylmethsuximide (NDMS) ClinCal Antiepileptics ClinCal Antiepileptics Desmethylolanzapine ClinCal Atypical Neuroleptics O-Desmethylvenlafaxine ClinCal Psychoactive Drugs TDM ClinCal Psychoactive Drugs TDM ClinCal Psychoactive Drugs TDM Diazepam ClinCal Benzodiazepines MS Diphenylhydantoin (Phenytoin) ClinCal Antiepileptics ClinCal Antiepileptics Dopamine ClinCal Catecholamines Doxepin ClinCal Psychoactive Drugs TDM ClinCal Tricyclic Antidepressants MS Duloxetine ClinCal Psychoactive Drugs TDM ClinCal Psychoactive Drugs TDM Efavirenz ClinCal Antiretrovirals MS Epinephrine ClinCal Catecholamines Escitalopram ClinCal Psychoactive Drugs TDM Estazolam ClinCal Benzodiazepines MS Ethosuximide ClinCal Antiepileptics ClinCal Antiepileptics Ethoxy acetic acid ClinCal Occupational Medicine Ethylglucuronide ClinCal Ethylglucuronide MS MS MS Ethylsulfate ClinCal Ethylglucuronide MS MS MS Etravirine ClinCal Antiretrovirals MS Everolimus ClinCal Immunosuppressants FAD (Flavin adenine dinucleotide, ClinCal Vitamin B1, B2 and B Vitamin B2) Felbamate ClinCal Antiepileptics MS ClinCal Antiepileptics Flavin adenine dinucleotide (FAD, ClinCal Vitamin B1, B2 and B Vitamin B2) ClinCal

81 Analyte Survey With ClinCal Calibrator Materials the following analytes are available: Analyte Matrix ClinCal Calibrator Order No. Page Analyte Matrix ClinCal Calibrator Order No. Page (alphabetical) Urine Plasma Serum Whole = available Blood = in preparation (alphabetical) Urine Plasma Serum Whole = available Blood = in preparation Fluconazole ClinCal Antimycotics Flunitrazepam ClinCal Benzodiazepines MS Fluoride ClinCal Trace Elements Fluoxetine ClinCal Psychoactive Drugs TDM Flurazepam ClinCal Benzodiazepines MS Fluvoxamine ClinCal Psychoactive Drugs TDM Gabapentine ClinCal Antiepileptics MS Glutamic Acid ClinCal Amino Acids Glutamine ClinCal Amino Acids Glutathione ClinCal Glutathione 3313 xxx Homocysteine ClinCal Homocysteine MS MS Homovanillic acid (HVA) ClinCal VMA, HVA, 5-HIAA HVA (Homovanillic acid) ClinCal VMA, HVA, 5-HIAA α-hydroxyalprazolam ClinCal Benzodiazepines MS Hydroxy-Carbamazepine ClinCal Antiepileptics ClinCal Antiepileptics MS ClinCal Antiepileptics ClinCal Psychoactive Drugs TDM ʼ-Hydroxycotinine ClinCal Nicotine and Metabolites MS Hydroxyindoleacetic acid ClinCal VMA, HVA, 5-HIAA (5-HIAA) Hydroxy-Itraconazole ClinCal Antimycotics Glycine ClinCal Amino Acids Gold ClinCal Trace Elements α-hydroxymidazolam ClinCal Benzodiazepines MS Hydroxyproline ClinCal Amino Acids ClinCal Hydroxyproline ClinCal Haloperidol ClinCal Psychoactive Drugs TDM Hb A1c (Hemoglobin A1c) ClinCal Hemoglobin A1c (HbA1c) , 176 Hb A2 (Hemoglobin A2) ClinCal Hemoglobin F / A Hb F (Hemoglobin F) ClinCal Hemoglobin F / A Hemoglobin A1c (Hb A1c) ClinCal Hemoglobin A1c (HbA1c) , 176 Hemoglobin A2 (Hb A2) ClinCal Hemoglobin F / A Hemoglobin F (Hb F) ClinCal Hemoglobin F / A Heptacarboxyporphyrin I ClinCal Porphyrins Hexacarboxyporphyrin lac, lab ClinCal Porphyrins HIAA ClinCal VMA, HVA, 5-HIAA (5-Hydroxyindoleacetic acid) Hippuric acid ClinCal Occupational Medicine Histidine ClinCal Amino Acids Hydroxypyrene ClinCal Phenolic Compounds Hydroxy-Risperidone ClinCal Psychoactive Drugs TDM (Paliperidone) ClinCal Risperidone, Paliperidone α-hydroxytriazolam ClinCal Benzodiazepines MS Hydroxy-Vitamin D2 ClinCal 25-OH Vitamins D2 / D MS Hydroxy-Vitamin D3 ClinCal 25-OH Vitamins D2 / D MS Imipramine ClinCal Psychoactive Drugs TDM ClinCal Tricyclic Antidepressants MS Indinavir ClinCal Antiretrovirals MS Iodide ClinCal Trace Elements Iron ClinCal Trace Elements Isoleucine ClinCal Amino Acids

82 Analyte Survey With ClinCal Calibrator Materials the following analytes are available: Analyte Matrix ClinCal Calibrator Order No. Page Analyte Matrix ClinCal Calibrator Order No. Page (alphabetical) Urine Plasma Serum Whole = available Blood = in preparation (alphabetical) Urine Plasma Serum Whole = available Blood = in preparation Itraconazole ClinCal Antimycotics Keppra (Levetiracetam) ClinCal Antiepileptics MS ClinCal Levetiracetam Lacosamide ClinCal Antiepileptics MS ClinCal Antiepileptics Lamotrigine ClinCal Antiepileptics MS ClinCal Antiepileptics ClinCal Lamotrigine and Sulthiame ClinCal Psychoactive Drugs TDM Lead ClinCal Trace Elements Leucine ClinCal Amino Acids Levetiracetam (Keppra ) ClinCal Antiepileptics MS ClinCal Levetiracetam Lithium ClinCal Trace Elements Lopinavir ClinCal Antiretrovirals MS Lorazepam ClinCal Benzodiazepines MS Lormetazepam ClinCal Benzodiazepines MS Lysine ClinCal Amino Acids Magnesium ClinCal Trace Elements Malondialdehyde ClinCal Malondialdehyde Mandelic acid ClinCal Occupational Medicine Manganese ClinCal Trace Elements Maprotiline ClinCal Psychoactive Drugs TDM ClinCal Tricyclic Antidepressants MS Maraviroc ClinCal Antiretrovirals MS Medazepam ClinCal Benzodiazepines MS Mercury ClinCal Trace Elements Metanephrine ClinCal Metanephrines MS1113 xxx Methionine ClinCal Amino Acids Methoxy acetic acid ClinCal Occupational Medicine Methoxytyramine ClinCal Metanephrines MS1113 xxx Methylenedianiline ClinCal Occupational Medicine N-Methylformamide ClinCal Occupational Medicine m/p-methyl-hippuric acid ClinCal Occupational Medicine o-methyl-hippuric acid ClinCal Occupational Medicine Methyl-histidine ClinCal Amino Acids Methyl-histidine ClinCal Amino Acids Methylmalonic Acid ClinCal Methylmalonic Acid MS Mianserin ClinCal Psychoactive Drugs TDM Midazolam ClinCal Benzodiazepines MS Mirtazapine ClinCal Psychoactive Drugs TDM ClinCal Psychoactive Drugs TDM Molybdenum ClinCal Trace Elements t,t-muconic acid ClinCal Occupational Medicine Mycophenolic Acid ClinCal Mycophenolic Acid Naphtol ClinCal Phenolic Compounds Naphtol ClinCal Phenolic Compounds NDMS (N-Desmethylmethsuximide) ClinCal Antiepileptics ClinCal Antiepileptics Nelfinavir ClinCal Antiretrovirals MS ClinCal

83 Analyte Survey With ClinCal Calibrator Materials the following analytes are available: Analyte Matrix ClinCal Calibrator Order No. Page Analyte Matrix ClinCal Calibrator Order No. Page (alphabetical) Urine Plasma Serum Whole = available Blood = in preparation (alphabetical) Urine Plasma Serum Whole = available Blood = in preparation Nevirapine ClinCal Antiretrovirals MS Nickel ClinCal Trace Elements Nicotine ClinCal Nicotine and Metabolites MS Nitrazepam ClinCal Benzodiazepines MS Norclobazam ClinCal Benzodiazepines MS Norclomipramine ClinCal Psychoactive Drugs TDM ClinCal Tricyclic Antidepressants MS Palladium ClinCal Trace Elements Paroxetine ClinCal Psychoactive Drugs TDM PBG (Porphobilinogen) ClinCal 5-ALA, PBG ClinCal Porphyrins PCP (Pentachlorophenol) ClinCal Phenolic Compounds PEMA (Phenylethyl-malonamide) ClinCal Antiepileptics Pentacarboxyporphyrin I ClinCal Porphyrins Norclozapine (Desmethylclozapine) ClinCal Atypical Neuroleptics ClinCal Psychoactive Drugs TDM ClinCal Psychoactive Drugs TDM ClinCal Tricyclic Antidepressants MS Nordiazepam ClinCal Benzodiazepines MS Nordoxepin ClinCal Psychoactive Drugs TDM ClinCal Tricyclic Antidepressants MS Norepinephrine ClinCal Catecholamines Norflunitrazepam ClinCal Benzodiazepines MS Normetanephrine ClinCal Metanephrines MS1113 xxx Pentachlorophenol (PCP) ClinCal Phenolic Compounds Perampanel ClinCal Antiepileptics Perazine ClinCal Psychoactive Drugs TDM Phenobarbital ClinCal Antiepileptics ClinCal Antiepileptics Phenol ClinCal Phenolic Compounds Phenylalanine ClinCal Amino Acids Phenylethyl-malonamide (PEMA) ClinCal Antiepileptics Phenylglyoxylic acid ClinCal Occupational Medicine S-Phenylmercapturic acid ClinCal Occupational Medicine ClinCal Nortriptyline ClinCal Psychoactive Drugs TDM ClinCal Tricyclic Antidepressants MS Olanzapine ClinCal Atypical Neuroleptics ClinCal Psychoactive Drugs TDM Ornithine ClinCal Amino Acids Oxazepam ClinCal Benzodiazepines MS Oxcarbazepine ClinCal Antiepileptics ClinCal Antiepileptics MS ClinCal Antiepileptics Paliperidone ClinCal Psychoactive Drugs TDM (9-Hydroxy-Risperidone) ClinCal Risperidone, Paliperidone Phenytoin (Diphenylhydantoin) ClinCal Antiepileptics ClinCal Antiepileptics Phosphoserine ClinCal Amino Acids Platinum ClinCal Trace Elements Porphobilinogen (PBG) ClinCal 5-ALA, PBG ClinCal Porphyrins Posaconazole ClinCal Antimycotics Potassium ClinCal Trace Elements

84 Analyte Survey With ClinCal Calibrator Materials the following analytes are available: Analyte Matrix ClinCal Calibrator Order No. Page Analyte Matrix ClinCal Calibrator Order No. Page (alphabetical) Urine Plasma Serum Whole = available Blood = in preparation (alphabetical) Urine Plasma Serum Whole = available Blood = in preparation Prazepam ClinCal Benzodiazepines MS Pregabaline ClinCal Antiepileptics MS Primidone ClinCal Antiepileptics ClinCal Antiepileptics Proline ClinCal Amino Acids Pyridoxal (Vitamin B6) ClinCal Vitamin B1, B2 and B ClinCal Vitamin B Pyridoxal-5-phosphate ClinCal Vitamin B1, B2 and B (Vitamin B6) ClinCal Vitamin B Quetiapine ClinCal Atypical Neuroleptics ClinCal Psychoactive Drugs TDM ClinCal Psychoactive Drugs TDM ClinCal Psychoactive Drugs TDM Raltegravir ClinCal Antiretrovirals MS Retigabine ClinCal Antiepileptics MS Retinol, all-trans (Vitamin A) ClinCal Vitamin A and E Silver ClinCal Trace Elements Sirolimus ClinCal Immunosuppressants Stiripentol ClinCal Antiepileptics MS Sulthiame ClinCal Antiepileptics MS ClinCal Antiepileptics ClinCal Lamotrigine and Sulthiame Tacrolimus ClinCal Immunosuppressants Taurine ClinCal Amino Acids Temazepam ClinCal Benzodiazepines MS Tetrazepam ClinCal Benzodiazepines MS ClinCal Risperidone ClinCal Psychoactive Drugs TDM ClinCal Risperidone, Paliperidone Ritonavir ClinCal Antiretrovirals MS Rufinamide ClinCal Antiepileptics MS ClinCal Antiepileptics Saquinavir ClinCal Antiretrovirals MS Selenium ClinCal Trace Elements Serine ClinCal Amino Acids Serotonin ClinCal Serotonin Sertindole ClinCal Psychoactive Drugs TDM Sertraline ClinCal Psychoactive Drugs TDM Thallium ClinCal Trace Elements Theobromine ClinCal Antiasthmatics Theophylline ClinCal Antiasthmatics Thiaminepyrophosphate (TPP, ClinCal Vitamin B1, B2 and B Vitamin B1) Threonine ClinCal Amino Acids Tiagabine ClinCal Antiepileptics MS Tin ClinCal Trace Elements Tipranavir ClinCal Antiretrovirals MS α-tocopherol (Vitamin E) ClinCal Vitamin A and E

85 Analyte Survey With ClinCal Calibrator Materials the following analytes are available: Analyte Matrix ClinCal Calibrator Order No. Page Analyte Matrix ClinCal Calibrator Order No. Page (alphabetical) Urine Plasma Serum Whole = available Blood = in preparation (alphabetical) Urine Plasma Serum Whole = available Blood = in preparation Topiramate ClinCal Antiepileptics MS TPP (Thiaminepyrophosphate, ClinCal Vitamin B1, B2 and B Vitamin B1) Trazodone ClinCal Benzodiazepines MS Triazolam ClinCal Benzodiazepines MS Trichloroacetic acid ClinCal Occupational Medicine Trimipramine ClinCal Psychoactive Drugs TDM ClinCal Tricyclic Antidepressants MS Tryptophane ClinCal Amino Acids Tyrosine ClinCal Amino Acids Ubiquinone (Coenzyme Q1) ClinCal Coenzyme Q Urea ClinCal Amino Acids Vitamin D2 ClinCal 25-OH Vitamins D2 / D MS Vitamin D3 ClinCal 25-OH Vitamins D2 / D MS Vitamin E ClinCal Vitamin A and E VMA (Vanillylmandelic acid) ClinCal VMA, HVA, 5-HIAA Voriconazole ClinCal Antimycotics Zaleplon ClinCal Benzodiazepines MS Zinc ClinCal Trace Elements Ziprasidone ClinCal Psychoactive Drugs TDM Zolpidem ClinCal Benzodiazepines MS Uroporphyrin I ClinCal Porphyrins Valine ClinCal Amino Acids Valproic acid ClinCal Antiepileptics Zonisamide ClinCal Antiepileptics MS ClinCal Antiepileptics Zopiclone ClinCal Benzodiazepines MS ClinCal Vanadium ClinCal Trace Elements Vanillylmandelic acid (VMA) ClinCal VMA, HVA, 5-HIAA Venlafaxine ClinCal Psychoactive Drugs TDM ClinCal Psychoactive Drugs TDM ClinCal Psychoactive Drugs TDM Vigabatrine ClinCal Antiepileptics MS Vitamin A ClinCal Vitamin A and E Vitamin B1 ClinCal Vitamin B1, B2 and B Vitamin B2 ClinCal Vitamin B1, B2 and B Vitamin B6 ClinCal Vitamin B1, B2 and B ClinCal Vitamin B Vitamin C ClinCal Vitamin C

86 Product Survey The analytes listed in the Analyte Survey (see pages ) are included in the following ClinCal Urine, Plasma, Serum, and Whole Blood Calibrators: ClinCal Urine Calibrators, Lyophilised: Nicotine and Metabolites (Calibrator Set) Cotinine, 3ʼ-hydroxycotinine, nicotine MS313 ClinCal Urine Calibrator Set, lyophil., for Nicotine and Metabolites 7 x 1 x 3 ml (Level - 6) 5-ALA, PBG 5-Aminolevulinic acid (5-ALA), porphobilinogen (PBG) ClinCal Urine Calibrator, lyophil., for 5-ALA, PBG 5 x 5 ml Catecholamines Dopamine, epinephrine, norepinephrine 213 ClinCal Urine Calibrator, lyophil., for Catecholamines 5 x 8 ml 2113 ClinCal Urine Calibrator, lyophil., for Catecholamines (FD) 5 x 5 ml Ethylglucuronide (Calibrator Sets) Ethylglucuronide, ethylsulfate MS8413 ClinCal Urine Calibrator Set, lyophil., for Ethylglucuronide 4 x 1 x 1 ml (Level - 3) MS8713 ClinCal Urine Calibrator Set, lyophil., for Ethylglucuronide 7 x 1 x 1 ml (Level - 6) Porphyrins 5-Aminolevulinic acid (5-ALA), coproporphyrin I, coproporphyrin III, heptacarboxyporphyrin I, hexacarboxyporphyrin Iac + Iab, pentacarboxyporphyrin I, porphobilinogen (PBG), uroporphyrin I 1713 ClinCal Urine Calibrator, lyophil., for Porphyrins 5 x 5 ml Serotonin See title 713 ClinCal Urine Calibrator, lyophil., for Serotonin 5 x 8 ml Parameters for Occupational Medicine Butoxy acetic acid, ethoxy acetic acid, hippuric acid, mandelic acid, methoxy acetic acid, methylenedianiline, N-methyl-formamide, m/p-methyl-hippuric acid, o-methyl-hippuric acid, t,t-muconic acid, phenylglyoxylic acid, S-phenylmercapturic acid, trichloroacetic acid 9922 ClinCal Urine Calibrator, lyophil., for Occupational Medicine 5 x 5 ml ClinCal Hydroxyproline See title 1613 ClinCal Urine Calibrator, lyophil., for Hydroxyproline 5 x 8 ml Phenolic Compounds Bisphenol A, o-cresol, 1-hydroxypyrene, 1-naphtol, 2-naphtol, pentachlorophenol, phenol 9925 ClinCal Urine Calibrator, lyophil., for Phenolic Compounds 5 x 5 ml Metanephrines Metanephrine, 3-methoxytyramine, normetanephrine 413 ClinCal Urine Calibrator, lyophil., for Metanephrines 5 x 8 ml Trace Elements Al, As, Be, Cd, Co, Cr, Cu, Fe, Fluoride, Hg, Iodide, Mg, Mn, Mo, Ni, Pb, Pd, Pt, Sb, Se, Sn, Tl, V, Zn 9988 ClinCal Urine Calibrator, lyophil., for Trace Elements 5 x 1 ml

87 Product Survey VMA, HVA, 5-HIAA Vanillylmandelic acid (VMA), homovanillic acid (HVA), 5-hydroxyindoleacetic acid (5-HIAA) 313 ClinCal Urine Calibrator, lyophil., for VMA, HVA, 5-HIAA 5 x 5 ml β-carotene See title 313 ClinCal Plasma Calibrator, lyophil., for β-carotene 5 x.5 ml ClinCal Plasma Calibrators, Lyophilised: Amino Acids (by Amino Acid Analyser) Alanine, α-aminobutyric acid, arginine, asparagine, aspartic acid, citrulline, glutamic acid, glutamine, glycine, histidine, hydroxyproline, isoleucine, leucine, lysine, methionine, 1-methyl-histidine, 3-methyl-histidine, ornithine, phenylalanine, phosphoserine, proline, serine, taurine, threonine, tryptophane, tyrosine, urea, valine 1213 ClinCal Plasma Calibrator, lyophil., for Amino Acids (by Amino Acid Analyser) 5 x 3 ml Catecholamines Dopamine, epinephrine, norepinephrine 113 ClinCal Plasma Calibrator, lyophil., for Catecholamines 5 x 5 ml Coenzyme Q1 See title 3113 ClinCal Plasma Calibrator, lyophil., for Coenzyme Q1 5 x 2 ml Antiasthmatics Caffeine, theobromine, theophylline 1213 ClinCal Plasma Calibrator, lyophil., for Antiasthmatics 1 x 3 ml Homocysteine See title 2313 ClinCal Plasma Calibrator, lyophil., for Homocysteine 1 x 3 ml ClinCal Antimycotics (Calibrator Set) Fluconazole, itraconazole, hydroxy-itraconazole, posaconazole, voriconazole 9939 ClinCal Plasma Calibrator Set, lyophil., for Antimycotics 4 x 1 x 1 ml (Level - 3) Lamotrigine and Sulthiame Lamotrigine, sulthiame ClinCal Plasma Calibrator, lyophil., for Lamotrigine and Sulthiame 1 x 3 ml Atypical Neuroleptics Clozapine, desmethylclozapine, desmethylolanzapine, olanzapine, quetiapine 413 ClinCal Plasma Calibrator, lyophil., for Atypical Neuroleptics 5 x 3 ml Malondialdehyde See title 3213 ClinCal Plasma Calibrator, lyophil., for Malondialdehyde 5 x.5 ml Paliperidone (9-OH-risperidone), risperidone 4113 ClinCal Plasma Calibrator, lyophil., for Risperidone, Paliperidone 5 x 5 ml

88 Product Survey Mycophenolic Acid (Single Point / Calibrator Set) See title 2913 ClinCal Plasma Calibrator, lyophil., for Mycophenolic Acid 1 x 3 ml (single point) 994 ClinCal Plasma Calibrator Set, lyophil., for Mycophenolic Acid 4 x 1 x 1 ml (Level - 3) Antiepileptics (Single Point / Calibrator Set) Bromide, carbamazepine, carbamazepine-epoxide, N-desmethylmethsuximide, ethosuximide, 1-hydroxy-carbamazepine, oxcarbazepine, PEMA, phenobarbital, phenytoin, primidone, valproic acid 1513 ClinCal Serum Calibrator, lyophil., Antiepileptics 1 x 3 ml Serotonin See title 613 ClinCal Plasma Calibrator, lyophil., for Serotonin 1 x 5 ml Felbamate, gabapentine, 1-hydroxy-carbamazepine, lacosamide, lamotrigine, levetiracetam, oxcarbazepine, perampanel, pregabaline, retigabine, rufinamide, stiripentol, sulthiame, tiagabine, topiramate, vigabatrine, zonisamide ClinCal Serum Calibrator, lyophil., Antiepileptics 2 1 x 2 ml Trace Elements Ag, Al, As, Au, Be, Bi, Cd, Co, Cr, Cu, Fluoride, Hg, Iodide, Li, Mg, Mn, Mo, Ni, Pd, Pt, Sb, Se, Sn, Tl, V, Zn 9985 ClinCal Plasma Calibrator, lyophil., for Trace Elements 5 x 3 ml ClinCal Serum Calibrators, Lyophilised: 1-OH-Carbamazepine, felbamate, gabapentine, lacosamide, lamotrigine, levetiracetam, oxcarbazepine, pregabaline, retigabine, rufinamide, stiripentol, sulthiame, tiagabine, topiramate, vigabatrine, zonisamide MS9213 ClinCal Serum Calibrator Set, lyophil., Antiepileptics 2 4 x 1 x 1 ml (Level - 3) Carbamazepine, carbamazepine-epoxide, ethosuximide, 1-hydroxy-carbamazepine, lamotrigine, oxcarbazepine, phenobarbital, phenytoin, primidone, sulthiame 1413 ClinCal Serum Calibrator, lyophil., Antiepileptics 3 1 x 3 ml ClinCal Amiodarone (Single Point / Calibrator Set) Amiodarone, desethylamiodarone 213 ClinCal Serum Calibrator, lyophil., for Amiodarone 1 x 3 ml 999 ClinCal Serum Calibrator Set, lyophil., for Amiodarone 4 x 1 x 2 ml (Level - 3) N-Desmethylmethsuximide, felbamate, lacosamide, rufinamide, zonisamide ClinCal Serum Calibrator, lyophil., Antiepileptics 4 1 x 3 ml Antiretrovirals (Calibrator Set) Amprenavir, atazanavir, darunavir, delavirdine, efavirenz, etravirine, indinavir, lopinavir, maraviroc, nelfinavir, nevirapine, raltegravir, ritonavir, saquinavir, tipranavir MS413 ClinCal Serum Calibrator Set, lyophil., for Antiretrovirals 7 x 1 x.5 ml (Level - 6)

89 Product Survey Benzodiazepines (Calibrator Set) Alprazolam, 7-aminoclonazepam, 7-aminoflunitrazepam, 7-aminonitrazepam, bromazepam, chlordiazepoxide, clobazam, clonazepam, demoxepam, desalkylflurazepam, diazepam, estazolam, flunitrazepam, flurazepam, α-hydroxyalprazolam, α-hydroxymidazolam, α-hydroxytriazolam, lorazepam, lormetazepam, medazepam, midazolam, nitrazepam, norclobazam, nordiazepam, norflunitrazepam, oxazepam, prazepam, temazepam, tetrazepam, trazodone, triazolam, zaleplon, zolpidem, zopiclone MS613 ClinCal Serum Calibrator Set, lyophil., for Benzodiazepines 4 x 1 x 1 ml (Level - 3) Ethylglucuronide (Calibrator Set) Ethylglucuronide, ethylsulfate MS8113 ClinCal Serum Calibrator Set, lyophil., for Ethylglucuronide 4 x 1 x 1 ml (Level - 3) Homocysteine (Calibrator Set) See title MS213 ClinCal Serum Calibrator Set, lyophil., for Homocysteine 4 x 1 x 1 ml (Level - 3) Levetiracetam (Keppra ) See title ClinCal Serum Calibrator, lyophil., for Levetiracetam (Keppra ) 1 x 3 ml Methylmalonic Acid (Calibrator Set) See title MS513 ClinCal Serum Calibrator Set, lyophil., for Methylmalonic Acid 4 x 1 x 2 ml (Level - 3) 174 Psychoactive Drugs TDM 1 - TDM 4, TDM 6 Aripiprazole, citalopram, O-desmethylvenlafaxine, 1-hydroxy-carbamazepine, lamotrigine, perazine, quetiapine, venlafaxine 972 ClinCal Serum Calibrator, lyophil., for Psychoactive Drugs TDM1 5 x 5 ml Amisulpride, O-desmethylvenlafaxine, escitalopram, mirtazapine, quetiapine, venlafaxine 975 ClinCal Serum Calibrator, lyophil., for Psychoactive Drugs TDM2 5 x 5 ml Clozapine, desmethylclozapine, duloxetine, haloperidol, olanzapine, paliperidone, quetiapine, risperidone, ziprasidone 978 ClinCal Serum Calibrator, lyophil., for Psychoactive Drugs TDM3 5 x 5 ml Amitriptyline, clomipramine, clozapine, desipramine, desmethylclozapine, doxepin, imipramine, maprotiline, norclomipramine, nordoxepin, nortriptyline, trimipramine 9711 ClinCal Serum Calibrator, lyophil., for Psychoactive Drugs TDM4 5 x 5 ml Aripiprazole, bupropion, citalopram, desmethylfluoxetine, O-desmethylvenlafaxine, duloxetine, fluoxetine, fluvoxamine, mianserin, mirtazapine, paroxetine, sertindole, sertraline, venlafaxine 9717 ClinCal Serum Calibrator, lyophil., for Psychoactive Drugs TDM6 5 x 5 ml Trace Elements Ag, Al, As, Au, Ba, Be, Bi, Cd, Co, Cr, Cu, Fe, Fluoride, Hg, Li, Mg, Mo, Mn, Ni, Pd, Pt, Sb, Se, Sn, Tl, V, Zn 9982 ClinCal Serum Calibrator, lyophil., for Trace Elements 5 x 3 ml Tricyclic Antidepressants (Calibrator Set) Amitriptyline, clomipramine, clozapine, desipramine, desmethylclozapine, doxepin, imipramine, maprotiline, norclomipramine, nordoxepin, nortriptyline, trimipramine MS9113 ClinCal Serum Calibrator Set, lyophil., for Tricyclic Antidepressants 4 x 1 x 1 ml (Level - 3) 175 ClinCal

90 Product Survey Vitamins A and E See title 2213 ClinCal Serum Calibrator, lyophil., for Vitamins A and E 1 x 3 ml Hemoglobins F/A2 Hemoglobin F, hemoglobin A ClinCal Hemolysate Calibrator, ready for use, for Hemoglobins F / A2 5 x 3 ml Vitamin B6 Pyridoxal, pyridoxal-5-phosphate (PLP) 2613 ClinCal Serum Calibrator, lyophil., for Vitamin B6 1 x 3 ml Homocysteine (Calibrator Set, DBS) See title MS2113 ClinCal Whole Blood Calibrator Set, filter spots, for Homocysteine 4 x 1 x 3 spots (Level - 3) Vitamin C See title 2813 ClinCal Serum Calibrator, lyophil., for Vitamin C 5 x.5 ml 25-OH Vitamin D2 / D3 (Single Point / Calibrator Set) 25-Hydroxy-vitamin D2, 25-hydroxy-vitamin D ClinCal Serum Calibrator, lyophil., for 25-OH Vitamin D2 / D3 5 x 2 ml (single point) MS713 ClinCal Serum Calibrator Set, lyophil., for 25-OH Vitamin D2 / D3 4 x 1 x 1 ml (Level - 3) ClinCal Whole Blood Calibrators, Lyophilised / Ready for Use: Immunosuppressants (Single Point / Calibrator Set) Cyclosporine A, everolimus, sirolimus, tacrolimus 513 ClinCal Whole Blood Calibrator, lyophil., 5 x 2 ml for Immunosuppressants (single point) 933 ClinCal Whole Blood Calibrator Set, lyophil., 4 x 1 x 2 ml for Immunosuppressants (Level - 3) 9933 ClinCal Whole Blood Calibrator Set, lyophil., 7 x 1 x 2 ml for Immunosuppressants (Level - 6) 928 ClinCal Whole Blood Calibrator, lyophil., 2 x 2 ml for Immunosuppressants (Level 7) Trace Elements Ag, As, Cd, Co, Cr, Cu, Hg, K, Mg, Mn, Ni, Pb, Pd, Pt, Se, Tl, Zn 9943 ClinCal Whole Blood Calibrator, lyophil., for Trace Elements 5 x 5 ml ClinCal Hemoglobin A1c See title 1111 ClinTest Reference Standard, ready for use, for HbA1c 1 x 5 ml Vitamins B1, B2, B6 Flavin adenine dinucleotide (FAD), pyridoxal, pyridoxal-5-phosphate (PLP), thiaminepyrophosphate (TPP) ClinCal Whole Blood Calibrator, lyophil., for Vitamins B1, B2 and B6 5 x 2 ml

91 Quality Assurance ClinChek Controls Analyte Survey Product Survey Urine Controls Plasma Controls Serum Controls Whole Blood Controls ClinChek 179

92 Analyte Survey With ClinChek are available: Control Materials the following analytes Analyte Matrix ClinChek Control Order No. Page Analyte Matrix ClinChek Control Order No. Page (alphabetical) Urine Plasma Serum Whole = available Blood = in preparation (alphabetical) Urine Plasma Serum Whole = available Blood = in preparation Acetylcarnitine ClinChek Acylcarn. a. Amino Acids ALA (5-Aminolevulinic acid) ClinChek 5-ALA / PBG ClinChek Porphyrins Alanine ClinChek Acylcarn. a. Amino Acids ClinChek Amino Acids Albumin # ClinChek CSF/Serum Quotients Alprazolam ClinChek Benzodiazepines MS Aluminium ClinChek Trace Elements α-aminobutyric acid ClinChek Amino Acids Aminoclonazepam ClinChek Benzodiazepines MS Aminoflunitrazepam ClinChek Benzodiazepines MS Aminolevulinic acid (5-ALA) ClinChek 5-ALA / PBG ClinChek Porphyrins Aminonitrazepam ClinChek Benzodiazepines MS Amiodarone ClinChek Amiodarone Amisulpride ClinChek Psychoactive Drugs TDM Amitriptyline ClinChek Psychoactive Drugs TDM Amprenavir ClinChek Antiretrovirals MS Antimony ClinChek Trace Elements Arginine ClinChek Acylcarn. a. Amino Acids ClinChek Amino Acids Aripiprazole ClinChek Psychoactive Drugs TDM ClinChek Psychoactive Drugs TDM Arsenic ClinChek Trace Elements Arsenic III ClinChek Arsenic Species Arsenic V ClinChek Arsenic Species Arsenobetaine ClinChek Arsenic Species Ascorbic Acid (Vitamin C) ClinChek Vitamin C Asialotransferrin ClinChek CDT Asparagine ClinChek Amino Acids Aspartic acid ClinChek Amino Acids Atazanavir ClinChek Antiretrovirals MS Barium ClinChek Trace Elements Beryllium ClinChek Trace Elements Bismuth ClinChek Trace Elements Bisphenol A ClinChek Phenolic Compounds Blank (Drugfree) ClinChek Drugfree Br2-CA [3-(2,2-Dibromovinyl)- ClinChek Parameters for ,2-dimethylcyclopropan- Environmental Medicine 1-carboxylic acid]) Bromazepam ClinChek Benzodiazepines MS Bromide ClinChek Antiepileptics Bupropion ClinChek Psychoactive Drugs TDM Butoxy acetic acid ClinChek Parameters for Occupational Medicine Butyrylcarnitine ClinChek Acylcarn. a. Amino Acids Cadmium ClinChek Trace Elements Caffeine ClinChek Antiasthmatics Carbamazepine ClinChek Antiepileptics ClinChek Antiepileptics Carbamazepine-epoxide ClinChek Antiepileptics ClinChek Antiepileptics Carbohydrate deficient ClinChek CDT transferrin (CDT) ClinChek # Serum and CSF

93 Analyte Survey With ClinChek are available: Control Materials the following analytes Analyte Matrix ClinChek Control Order No. Page Analyte Matrix ClinChek Control Order No. Page (alphabetical) Urine Plasma Serum Whole = available Blood = in preparation (alphabetical) Urine Plasma Serum Whole = available Blood = in preparation Carnitine ClinChek Acylcarn. a. Amino Acids β-carotene ClinChek β-carotene CDT (Carbohydrate ClinChek CDT deficient transferrin) Chlordiazepoxide ClinChek Benzodiazepines MS Chromium ClinChek Trace Elements Citalopram ClinChek Psychoactive Drugs TDM ClinChek Psychoactive Drugs TDM Citrulline ClinChek Acylcarn. a. Amino Acids ClinChek Amino Acids cis-cl2-ca [cis-3- ClinChek Parameters for (2,2-Dichlorovinyl)- Environmental Medicine 2,2-dimethylcyclopropan- 1-carboxylic acid] trans-cl2-ca [trans-3- ClinChek Parameters for (2,2-Dichlorovinyl)- Environmental Medicine 2,2-dimethylcyclopropan- 1-carboxylic acid] Clobazam ClinChek Benzodiazepines MS Clomipramine ClinChek Psychoactive Drugs TDM Clonazepam ClinChek Benzodiazepines MS Clozapine ClinChek Atypical Neuroleptics ClinChek Psychoactive Drugs TDM ClinChek Psychoactive Drugs TDM Cobalt ClinChek Trace Elements Coenzyme Q1 (Ubiquinone) ClinChek Coenzyme Q Copper ClinChek Trace Elements Coproporphyrin I ClinChek Porphyrins Coproporphyrin III ClinChek Porphyrins Cotinine ClinChek Nicotine and Metabolites MS o-cresol ClinChek Phenolic Compounds Cyclosporine A ClinChek Immunosuppressants Darunavir ClinChek Antiretrovirals MS Decanoylcarnitine ClinChek Acylcarn. a. Amino Acids Delavirdine ClinChek Antiretrovirals MS Demoxepam ClinChek Benzodiazepines MS Desalkylflurazepam ClinChek Benzodiazepines MS Desethylamiodarone ClinChek Amiodarone Desipramine ClinChek Psychoactive Drugs TDM Desmethylclozapine ClinChek Atypical Neuroleptics (Norclozapine) ClinChek Psychoactive Drugs TDM ClinChek Psychoactive Drugs TDM Desmethylfluoxetine ClinChek Psychoactive Drugs TDM N-Desmethylmethsuximide (NDMS) ClinChek Antiepileptics ClinChek Antiepileptics Desmethylolanzapine ClinChek Atypical Neuroleptics Desmethylsertraline ClinChek Psychoactive Drugs TDM O-Desmethylvenlafaxine ClinChek Psychoactive Drugs TDM ClinChek Psychoactive Drugs TDM ClinChek Psychoactive Drugs TDM Diazepam ClinChek Benzodiazepines MS Dimethylarsinic Acid ClinChek Arsenic Species Diphenylhydantoin (Phenytoin) ClinChek Antiepileptics ClinChek Antiepileptics Disialotransferrin ClinChek CDT Dodecanoylcarnitine ClinChek Acylcarn. a. Amino Acids Dopamine ClinChek Biogenic Amines ClinChek Catecholamines (FD) Doxepin ClinChek Psychoactive Drugs TDM ClinChek

94 Analyte Survey With ClinChek are available: Control Materials the following analytes Analyte Matrix ClinChek Control Order No. Page Analyte Matrix ClinChek Control Order No. Page (alphabetical) Urine Plasma Serum Whole = available Blood = in preparation (alphabetical) Urine Plasma Serum Whole = available Blood = in preparation Duloxetine ClinChek Psychoactive Drugs TDM ClinChek Psychoactive Drugs TDM Efavirenz ClinChek Antiretrovirals MS Epinephrine ClinChek Biogenic Amines ClinChek Catecholamines (FD) Escitalopram ClinChek Psychoactive Drugs TDM Estazolam ClinChek Benzodiazepines MS Ethosuximide ClinChek Antiepileptics ClinChek Antiepileptics Ethoxy acetic acid ClinChek Parameters for Occupational Medicine Ethylglucuronide ClinChek Ethylglucuronide MS MS Ethylsulfate ClinChek Ethylglucuronide MS MS Etravirine ClinChek Antiretrovirals MS Everolimus ClinChek Immunosuppressants FAD (Flavin adenine dinucleotide, ClinChek Vitamins Vitamin B2) Felbamate ClinChek Antiepileptics ClinChek Antiepileptics Flavin adenine dinucleotide (FAD, ClinChek Vitamins Vitamin B2) Fluconazole ClinChek Antimycotics Flunitrazepam ClinChek Benzodiazepines MS Fluoride ClinChek Trace Elements Fluoxetine ClinChek Psychoactive Drugs TDM Flurazepam ClinChek Benzodiazepines MS Fluvoxamine ClinChek Psychoactive Drugs TDM Free hemoglobin ClinChek Free Hemoglobin ClinChek Free Hemoglobin (low) Gabapentine ClinChek Antiepileptics Glucose # ClinChek CSF/Serum Quotients Glutamic acid ClinChek Acylcarn. a. Amino Acids ClinChek Amino Acids Glutamine ClinChek Amino Acids Glutarylcarnitine ClinChek Acylcarn. a. Amino Acids Glutathione ClinChek Glutathione xxx Glycine ClinChek Acylcarn. a. Amino Acids ClinChek Amino Acids Gold ClinChek Trace Elements Haloperidol ClinChek Psychoactive Drugs TDM Hb A1c (Hemoglobin A1c) ClinChek Hemoglobin A1c Hb A2 (Hemoglobin A2) ClinChek Hemoglobins F / A ClinChek Hemoglobins F / A2 / S Hb F (Hemoglobin F) ClinChek Hemoglobin A1c ClinChek Hemoglobins F / A ClinChek Hemoglobins F / A2 / S Hb S (Hemoglobin S) ClinChek Hemoglobins F / A2 / S Hemoglobin A1c (Hb A1c) ClinChek Hemoglobin A1c Hemoglobin A2 (Hb A2) ClinChek Hemoglobins F / A ClinChek Hemoglobins F / A2 / S Hemoglobin F (Hb F) ClinChek Hemoglobin A1c ClinChek Hemoglobins F / A ClinChek Hemoglobins F / A2 / S Hemoglobin S (Hb S) ClinChek Hemoglobins F / A2 / S Hemoglobin, free ClinChek Free Hemoglobin ClinChek Free Hemoglobin (low) Heptacarboxyporphyrin I ClinChek Porphyrins Hexacarboxyporphyrin Iab + lac ClinChek Porphyrins Hexadecanoylcarnitine ClinChek Acylcarn. a. Amino Acids Hexanoylcarnitine ClinChek Acylcarn. a. Amino Acids ClinChek # Serum and CSF

95 Analyte Survey With ClinChek are available: Control Materials the following analytes Analyte Matrix ClinChek Control Order No. Page Analyte Matrix ClinChek Control Order No. Page (alphabetical) Urine Plasma Serum Whole = available Blood = in preparation (alphabetical) Urine Plasma Serum Whole = available Blood = in preparation Hexasialotransferrin ClinChek CDT HIAA (5-Hydroxyindoleacetic acid) ClinChek Biogenic Amines Hippuric acid ClinChek Parameters for Occupational Medicine Histidine ClinChek Amino Acids Homocysteine ClinChek Homocysteine MS Homovanillic acid (HVA) ClinChek Biogenic Amines HVA (Homovanillic acid) ClinChek Biogenic Amines α-hydroxyalprazolam ClinChek Benzodiazepines MS Hydroxybupropion ClinChek Psychoactive Drugs TDM Hydroxy-Carbamazepine ClinChek Antiepileptics ClinChek Antiepileptics ClinChek Antiepileptics ClinChek Psychoactive Drugs TDM Hydroxycotinine ClinChek Nicotine and Metabolites MS Hydroxyindoleacetic acid (5-HIAA) ClinChek Biogenic Amines Hydroxy-Itraconazole ClinChek Antimycotics α-hydroxymidazolam ClinChek Benzodiazepines MS Hydroxyproline ClinChek Amino Acids ClinChek Biogenic Amines Hydroxypyrene ClinChek Phenolic Compounds Hydroxy-Risperidone ClinChek Psychoactive Drugs TDM (Paliperidone) ClinChek Risperidone, Paliperidone α-hydroxytriazolam ClinChek Benzodiazepines MS Hydroxy-Vitamin D2 ClinChek 25-OH Vitamins D2 / D MS Hydroxy-Vitamin D3 ClinChek 25-OH Vitamins D2 / D MS IgA (Immunoglobuline A) # ClinChek CSF/Serum Quotients IgG (Immunoglobuline G) # ClinChek CSF/Serum Quotients IgM (Immunoglobuline M) # ClinChek CSF/Serum Quotients Imipramine ClinChek Psychoactive Drugs TDM Immunoglobuline A (IgA) # ClinChek CSF/Serum Quotients Immunoglobuline G (IgG) # ClinChek CSF/Serum Quotients Immunoglobuline M (IgM) # ClinChek CSF/Serum Quotients Indinavir ClinChek Antiretrovirals MS Iodide ClinChek Trace Elements Iron ClinChek Trace Elements Isoleucine ClinChek Amino Acids Isovalerylcarnitine ClinChek Acylcarn. a. Amino Acids Itraconazole ClinChek Antimycotics Keppra (Levetiracetam) ClinChek Antiepileptics ClinChek Levetiracetam Lacosamide ClinChek Antiepileptics ClinChek Antiepileptics Lactate # ClinChek CSF/Serum Quotients Lamotrigine ClinChek Antiepileptics ClinChek Antiepileptics ClinChek Lamotrigine a. Sulthiame ClinChek Psychoactive Drugs TDM Lead ClinChek Trace Elements Leucine ClinChek Acylcarn. a. Amino Acids ClinChek Amino Acids Levetiracetam (Keppra ) ClinChek Antiepileptics ClinChek Levetiracetam Lithium ClinChek Trace Elements Lopinavir ClinChek Antiretrovirals MS Lorazepam ClinChek Benzodiazepines MS ClinChek # Serum and CSF # Serum and CSF

96 Analyte Survey With ClinChek are available: Control Materials the following analytes Analyte Matrix ClinChek Control Order No. Page Analyte Matrix ClinChek Control Order No. Page (alphabetical) Urine Plasma Serum Whole = available Blood = in preparation (alphabetical) Urine Plasma Serum Whole = available Blood = in preparation Lormetazepam ClinChek Benzodiazepines MS Lysine ClinChek Amino Acids Magnesium ClinChek Trace Elements Malondialdehyde ClinChek Malondialdehyde Malonylcarnitine ClinChek Acylcarn. a. Amino Acids Mandelic acid ClinChek Parameters for Occupational Medicine Manganese ClinChek Trace Elements Maprotiline ClinChek Psychoactive Drugs TDM Maraviroc ClinChek Antiretrovirals MS MBzP (Mono-benzylphthalate) ClinChek Parameters for Environmental Medicine Medazepam ClinChek Benzodiazepines MS OH-MEHP [Mono-(2-ethyl- ClinChek Parameters for hydroxyhexyl) phthalate] Environmental Medicine 5-oxo-MEHP [Mono-(2-ethyl- ClinChek Parameters for oxohexyl) phthalate] Environmental Medicine 5-cx-MEPP [Mono-(2-ethyl- ClinChek Parameters for carboxypentyl) phthalate] Environmental Medicine Mercury ClinChek Trace Elements Metanephrine ClinChek Biogenic Amines ClinChek Metanephrines MS xxx Methionine ClinChek Acylcarn. a. Amino Acids ClinChek Amino Acids Methoxy acetic acid ClinChek Parameters for Occupational Medicine 3-Methoxytyramine ClinChek Biogenic Amines ClinChek Metanephrines MS xxx Methylenedianiline ClinChek Parameters for Occupational Medicine N-Methylformamide ClinChek Parameters for Occupational Medicine m/p-methyl-hippuric acid ClinChek Parameters for Occupational Medicine o-methyl-hippuric acid ClinChek Parameters for Occupational Medicine 1-Methyl-histidine ClinChek Amino Acids Methyl-histidine ClinChek Amino Acids Methylmalonic Acid ClinChek Methylmalonic Acid MS Methylmalonylcarnitine ClinChek Acylcarn. a. Amino Acids Mianserin ClinChek Psychoactive Drugs TDM MiBP (Mono-iso-butylphthalate) ClinChek Parameters for Environmental Medicine Midazolam ClinChek Benzodiazepines MS Mirtazapine ClinChek Psychoactive Drugs TDM ClinChek Psychoactive Drugs TDM MnBP (Mono-n-butylphthalate) ClinChek Parameters for Environmental Medicine Molybdenum ClinChek Trace Elements Monomethylarsonic Acid ClinChek Arsenic Species t,t-muconic Acid ClinChek Parameters for Occupational Medicine Mycophenolic Acid ClinChek Mycophenolic Acid Naphthol ClinChek Phenolic Compounds Naphthol ClinChek Phenolic Compounds NDMS (N-Desmethylmethsuximide) ClinChek Antiepileptics ClinChek Antiepileptics ClinChek

97 Analyte Survey With ClinChek are available: Control Materials the following analytes Analyte Matrix ClinChek Control Order No. Page Analyte Matrix ClinChek Control Order No. Page (alphabetical) Urine Plasma Serum Whole = available Blood = in preparation (alphabetical) Urine Plasma Serum Whole = available Blood = in preparation Nelfinavir ClinChek Antiretrovirals MS Nevirapine ClinChek Antiretrovirals MS Nickel ClinChek Trace Elements Nicotine ClinChek Nicotine and Metabolites MS Nitrazepam ClinChek Benzodiazepines MS Norclobazam ClinChek Benzodiazepines MS Norclomipramine ClinChek Psychoactive Drugs TDM Norclozapine ClinChek Atypical Neuroleptics (Desmethylclozapine) ClinChek Psychoactive Drugs TDM ClinChek Psychoactive Drugs TDM Nordiazepam ClinChek Benzodiazepines MS Nordoxepin ClinChek Psychoactive Drugs TDM Norepinephrine ClinChek Biogenic Amines ClinChek Catecholamines (FD) Norflunitrazepam ClinChek Benzodiazepines MS Normetanephrine ClinChek Biogenic Amines ClinChek Metanephrines MS xxx Nortriptyline ClinChek Psychoactive Drugs TDM Octadecanoylcarnitine ClinChek Acylcarn. a. Amino Acids Octanoylcarnitine ClinChek Acylcarn. a. Amino Acids Olanzapine ClinChek Atypical Neuroleptics ClinChek Psychoactive Drugs TDM Ornithine ClinChek Acylcarn. a. Amino Acids ClinChek Amino Acids ortho-cresol ClinChek Phenolic Compounds Oxazepam ClinChek Benzodiazepines MS Oxcarbazepine ClinChek Antiepileptics ClinChek Antiepileptics ClinChek Antiepileptics Paliperidone ClinChek Psychoactive Drugs TDM (9-Hydroxy-Risperidone) ClinChek Risperidone, Paliperidone Palladium ClinChek Trace Elements Paroxetine ClinChek Psychoactive Drugs TDM PBA (3-Phenoxybenzoic acid) ClinChek Parameters for Environmental Medicine PBG (Porphobilinogen) ClinChek 5-ALA / PBG ClinChek Porphyrins PEMA (Phenylethyl-malonamide) ClinChek Antiepileptics Pentacarboxyporphyrin I ClinChek Porphyrins Pentachlorophenol ClinChek Phenolic Compounds Pentasialotransferrin ClinChek CDT Perampanel ClinChek Antiepileptics Perazine ClinChek Psychoactive Drugs TDM Phenobarbital ClinChek Antiepileptics ClinChek Antiepileptics Phenol ClinChek Phenolic Compounds Phenoxybenzoic acid (3-PBA) ClinChek Parameters for Environmental Medicine Phenylalanine ClinChek Acylcarn. a. Amino Acids ClinChek Amino Acids Phenylethyl-malonamide (PEMA) ClinChek Antiepileptics Phenylglyoxylic acid ClinChek Parameters for Occupational Medicine S-Phenylmercapturic acid ClinChek Parameters for Occupational Medicine Phenytoin (Diphenylhydantoin) ClinChek Antiepileptics ClinChek Antiepileptics Phosphoserine ClinChek Amino Acids ClinChek

98 Analyte Survey With ClinChek are available: Control Materials the following analytes Analyte Matrix ClinChek Control Order No. Page Analyte Matrix ClinChek Control Order No. Page (alphabetical) Urine Plasma Serum Whole = available Blood = in preparation (alphabetical) Urine Plasma Serum Whole = available Blood = in preparation Platinum ClinChek Trace Elements Porphobilinogen (PBG) ClinChek 5-ALA / PBG ClinChek Porphyrins Posaconazole ClinChek Antimycotics Potassium ClinChek Trace Elements Prazepam ClinChek Benzodiazepines MS Pregabaline ClinChek Antiepileptics Primidone ClinChek Antiepileptics ClinChek Antiepileptics Proline ClinChek Amino Acids Propionylcarnitine ClinChek Acylcarn. a. Amino Acids Pyridoxal (Vitamin B6) ClinChek Vitamins Pyridoxal-5-phosphate ClinChek Vitamins (Vitamin B6) Quetiapine ClinChek Atypical Neuroleptics ClinChek Psychoactive Drugs TDM ClinChek Psychoactive Drugs TDM ClinChek Psychoactive Drugs TDM Raltegravir ClinChek Antiretrovirals MS Retigabine ClinChek Antiepileptics Retinol, all-trans (Vitamin A) ClinChek Vitamins Risperidone ClinChek Psychoactive Drugs TDM ClinChek Risperidone, Paliperidone Ritonavir ClinChek Antiretrovirals MS Rufinamide ClinChek Antiepileptics ClinChek Antiepileptics Saquinavir ClinChek Antiretrovirals MS Selenium ClinChek Trace Elements Serine ClinChek Amino Acids Serotonin ClinChek Biogenic Amines Sertindole ClinChek Psychoactive Drugs TDM Sertraline ClinChek Psychoactive Drugs TDM Silver ClinChek Trace Elements Sirolimus ClinChek Immunosuppressants Stiripentol ClinChek Antiepileptics Sulthiame ClinChek Antiepileptics ClinChek Antiepileptics ClinChek Lamotrigine a. Sulthiame Tacrolimus ClinChek Immunosuppressants Taurine ClinChek Amino Acids Temazepam ClinChek Benzodiazepines MS Tetradecanoylcarnitine ClinChek Acylcarn. a. Amino Acids Tetrasialotransferrin ClinChek CDT Tetrazepam ClinChek Benzodiazepines MS Thallium ClinChek Trace Elements Theobromine ClinChek Antiasthmatics Theophylline ClinChek Antiasthmatics Thiaminepyrophosphate (TPP, ClinChek Vitamins Vitamin B1) Threonine ClinChek Amino Acids Tiagabine ClinChek Antiepileptics Tin ClinChek Trace Elements Tipranavir ClinChek Antiretrovirals MS ClinChek

99 Analyte Survey With ClinChek are available: Control Materials the following analytes Analyte Matrix ClinChek Control Order No. Page Analyte Matrix ClinChek Control Order No. Page (alphabetical) Urine Plasma Serum Whole = available Blood = in preparation (alphabetical) Urine Plasma Serum Whole = available Blood = in preparation α-tocopherol (Vitamin E) ClinChek Vitamins Topiramat ClinChek Antiepileptics Total porphyrins ClinChek 5-ALA / PBG ClinChek Porphyrins Total protein # ClinChek CSF/Serum Quotients TPP (Thiaminepyrophosphate, ClinChek Vitamins Vitamin B1) Trazodone ClinChek Benzodiazepines MS Triazolam ClinChek Benzodiazepines MS Trichloroacetic acid ClinChek Parameters for Occupational Medicine Trimipramine ClinChek Psychoactive Drugs TDM Trisialotransferrin ClinChek CDT Tryptophane ClinChek Amino Acids Tyrosine ClinChek Acylcarn. a. Amino Acids ClinChek Amino Acids Ubiquinone (Coenzyme Q1) ClinChek Coenzyme Q Urea ClinChek Amino Acids Uroporphyrin I ClinChek Porphyrins Valine ClinChek Acylcarn. a. Amino Acids ClinChek Amino Acids Vitamin B1 ClinChek Vitamins Vitamin B2 ClinChek Vitamins Vitamin B6 ClinChek Vitamins Vitamin C ClinChek Vitamin C Vitamin D2 ClinChek 25-OH Vitamins D2 / D MS Vitamin D3 ClinChek 25-OH Vitamins D2 / D MS Vitamin E ClinChek Vitamins VMA (Vanillylmandelic acid) ClinChek Biogenic Amines Voriconazole ClinChek Antimycotics Zaleplon ClinChek Benzodiazepines MS Zinc ClinChek Trace Elements Ziprasidone ClinChek Psychoactive Drugs TDM Zolpidem ClinChek Benzodiazepines MS Zonisamide ClinChek Antiepileptics ClinChek Antiepileptics Zopiclone ClinChek Benzodiazepines MS ClinChek Valproic acid ClinChek Antiepileptics Vanadium ClinChek Trace Elements Vanillylmandelic acid (VMA) ClinChek Biogenic Amines Venlafaxine ClinChek Psychoactive Drugs TDM ClinChek Psychoactive Drugs TDM ClinChek Psychoactive Drugs TDM Vigabatrine ClinChek Antiepileptics Vitamin A ClinChek Vitamins # Serum and CSF

100 Product Survey The analytes listed in the Analyte Survey (see pages ) are included in the following ClinChek Urine, Plasma, Serum, and Whole Blood Controls: ClinChek Urine Controls, Lyophilised: 5-ALA, PBG, Total Porphyrins 5-Aminolevulinic acid (5-ALA), porphobilinogen (PBG), total porphyrins 1728 ClinChek Urine Control, lyophil., for 5-ALA, PBG, Level I 1 x 5 ml ClinChek Urine Control, lyophil., for 5-ALA, PBG, Level II 1 x 5 ml ClinChek Urine Control, lyophil., for 5-ALA, PBG, Level I, II 2 x 5 x 5 ml Arsenic Species Arsenic III, arsenic V, arsenobetaine, dimethylarsinic acid, monomethylarsonic acid 8931 ClinChek Urine Control, lyophil., for Arsenic Species, Level I, II 2 x 5 x 5 ml Biogenic Amines Dopamine, epinephrine, homovanillic acid (HVA), 5-hydroxyindoleacetic acid (5-HIAA), hydroxyproline, metanephrine, 3-methoxytyramine, norepinephrine, normetanephrine, serotonin, vanillylmandelic acid (VMA) 882 ClinChek Urine Control, lyophil., for Biogenic Amines, Level I 1 x 8 ml 8821 ClinChek Urine Control, lyophil., for Biogenic Amines, Level II 1 x 8 ml 8822 ClinChek Urine Control, lyophil., for Biogenic Amines, Level I, II 2 x 5 x 8 ml Ethylglucuronide Ethylglucuronide, ethylsulfate MS88 ClinChek Urine Control, lyophil., for Ethylglucuronide, Level I 1 x 1 ml MS881 ClinChek Urine Control, lyophil., for Ethylglucuronide, Level II 1 x 1 ml MS882 ClinChek Urine Control, lyophil., for Ethylglucuronide, Level III 1 x 1 ml MS883 ClinChek Urine Control, lyophil., for Ethylglucuronide, Level I, II, III 3 x 3 x 1 ml Nicotine and Metabolites Cotinine, 3ʼ-hydroxycotinine, nicotine MS38 ClinChek Urine Control, lyophil., for Nicotine and Metabolites, Level I 5 x 3 ml MS381 ClinChek Urine Control, lyophil., for Nicotine and Metabolites, Level II 5 x 3 ml MS382 ClinChek Urine Control, lyophil., for Nicotine and Metabolites, Level III 5 x 3 ml MS383 ClinChek Urine Control, lyophil., for Nicotine and Metabolites, Level I, II, III 3 x 2 x 3 ml Parameters for Environmental Medicine Br2-CA [3-(2,2-dibromovinyl)-2,2-dimethylcyclopropan-1-carboxylic acid], cis-cl2-ca [cis-3-(2,2-dichlorovinyl)-2,2-dimethylcyclopropan-1-carboxylic acid], trans-cl2-ca [trans-3-(2,2-dichlorovinyl)-2,2-dimethylcyclopropan-1-carboxylic acid], MBzP [Mono-benzylphthalate], 5-OH-MEHP [Mono-(2-ethyl-5-hydroxyhexyl)phthalate], 5-oxo-MEHP [Mono-(2-ethyl-5-oxohexyl)phthalate], 5-cx-MEPP [Mono-(2-ethyl-5- carboxypentyl)phthalate], MiBP [Mono-iso-butylphthalate], MnBP [Mono-n-butylphthalate], 3-PBA [3-phenoxybenzoic acid] 8928 ClinChek Urine Control, lyophil., for Environmental Medicine, Level I, II 2 x 5 x 5 ml ClinChek Catecholamines Dopamine, epinephrine, norepinephrine 218 ClinChek Urine Control, lyophil., for Catcholamines (FD), Level I 1 x 5 ml 2181 ClinChek Urine Control, lyophil., for Catcholamines (FD), Level II 1 x 5 ml 2182 ClinChek Urine Control, lyophil., for Catcholamines (FD), Level III 2 x 5 x 5 ml Parameters for Occupational Medicine Butoxy acetic acid, ethoxy acetic acid, hippuric acid, mandelic acid, methoxy acetic acid, methylenedianiline, N-methyl-formamide, m/p-methyl-hippuric acid, o-methyl-hippuric acid, t,t-muconic acid, phenylglyoxylic acid, S-phenylmercapturic acid, trichloroacetic acid 8922 ClinChek Urine Control, lyophil., for Occupational Medicine, Level I, II 2 x 5 x 5 ml

101 Product Survey Phenolic Compounds Bisphenol A, o-cresol, 1-hydroxypyrene, 1-naphthol, 2-naphthol, pentachlorophenol, phenol 8925 ClinChek Urine Control, lyophil., for Phenolic Compounds, Level I, II 2 x 5 x 5 ml Porphyrins 5-Aminolevulinic acid (5-ALA), coproporphyrin I, coproporphyrin III, heptacarboxyporphyrin I, hexacarboxyporphyrin Iac + Iab, pentacarboxyporphyrin I, porphobilinogen (PBG), total porphyrins, uroporphyrin I 178 ClinChek Urine Control, lyophil., for Porphyrins, Level I 1 x 5 ml 1781 ClinChek Urine Control, lyophil., for Porphyrins, Level II 1 x 5 ml 1782 ClinChek Urine Control, lyophil., for Porphyrins, Level I, II 2 x 5 x 5 ml Trace Elements Al, As, Be, Cd, Co, Cr, Cu, Fluoride, Fe, Hg, Iodide, Mg, Mn, Mo, Ni, Pb, Pd, Pt, Sb, Se, Sn, Tl, V, Zn 8847 ClinChek Urine Control, lyophil., for Trace Elements, Level I 1 x 1 ml 8848 ClinChek Urine Control, lyophil., for Trace Elements, Level II 1 x 1 ml 8849 ClinChek Urine Control, lyophil., for Trace Elements, Level I, II 2 x 5 x 1 ml ClinChek Plasma Controls, Lyophilised: Antiasthmatics Caffeine, theobromine, theophylline 128 ClinChek Plasma Control, lyophil., for Antiasthmatics, Level I 1 x 3 ml 1281 ClinChek Plasma Control, lyophil., for Antiasthmatics, Level II 1 x 3 ml 1282 ClinChek Plasma Control, lyophil., for Antiasthmatics, Level I, II 2 x 5 x 3 ml Antimycotics Fluconazole, hydroxy-itraconazole, itraconazole, posaconazole, voriconazole 8839 ClinChek Plasma Control, lyophil., for Antimycotics, Level I, II, III 3 x 2 x 1 ml Atypical Neuroleptics Clozapine, desmethylclozapine, desmethylolanzapine, olanzapine, quetiapine 48 ClinChek Plasma Control, lyophil., for Atypical Neuroleptics, Level I 1 x 3 ml 481 ClinChek Plasma Control, lyophil., for Atypical Neuroleptics, Level II 1 x 3 ml 482 ClinChek Plasma Control, lyophil., for Atypical Neuroleptics, Level I, II 2 x 5 x 3 ml Paliperidone (9-hydroxy-risperidone), risperidone 418 ClinChek Plasma Control, lyophil., for Risperidone, Paliperidone, Level I 1 x 5 ml 4181 ClinChek Plasma Control, lyophil., for Risperidone, Paliperidone, Level II 1 x 5 ml 4182 ClinChek Plasma Control, lyophil., for Risperidone, Paliperidone, Level I, II 2 x 5 x 5 ml ClinChek Amino Acids (by Amino Acid Analyser) Alanine, α-aminobutyric acid, arginine, asparagine, aspartic acid, citrulline, glutamic acid, glutamine, glycine, histidine, hydroxyproline, isoleucine, leucine, lysine, methionine, 1-methyl-histidine, 3-methyl-histidine, ornithine, phenylalanine, phosphoserine, proline, serine, taurine, threonine, tryptophane, tyrosine, urea, valine 128 ClinChek Plasma Control, lyophil., for Amino Acids (by Amino Acid Analyser), Level I 1 x 3 ml 1281 ClinChek Plasma Control, lyophil., for Amino Acids (by Amino Acid Analyser), Level II 1 x 3 ml 1282 ClinChek Plasma Control, lyophil., for Amino Acids (by Amino Acid Analyser), Level I, II 2 x 5 x 3 ml Biogenic Amines Dopamine, epinephrine, norepinephrine, serotonin 881 ClinChek Plasma Control, lyophil., for Biogenic Amines, Level I 1 x 5 ml 8811 ClinChek Plasma Control, lyophil., for Biogenic Amines, Level II 1 x 5 ml 889 ClinChek Plasma Control, lyophil., for Biogenic Amines, Level I, II 2 x 5 x 5 ml

102 Product Survey β-carotene See title 38 ClinChek Plasma Control, lyophil., for β-carotene, Level I 1 x 2 ml 381 ClinChek Plasma Control, lyophil., for β-carotene, Level II 1 x 2 ml 382 ClinChek Plasma Control, lyophil., for β-carotene, Level I, II 2 x 5 x 2 ml Malondialdehyde See title 328 ClinChek Plasma Control, lyophil., for Malondialdehyde, Level I 1 x.5 ml 3281 ClinChek Plasma Control, lyophil., for Malondialdehyde, Level II 1 x.5 ml 3282 ClinChek Plasma Control, lyophil., for Malondialdehyde, Level I, II 2 x 5 x.5 ml Coenzyme Q1 See title 318 ClinChek Plasma Control, lyophil., for Coenzyme Q1, Level I 1 x 2 ml 3181 ClinChek Plasma Control, lyophil., for Coenzyme Q1, Level II 1 x 2 ml 3182 ClinChek Plasma Control, lyophil., for Coenzyme Q1, Level I, II 2 x 5 x 2 ml Mycophenolic Acid See title 298 ClinChek Plasma Control, lyophil., for Mycophenolic Acid, Level I 1 x 3 ml 2981 ClinChek Plasma Control, lyophil., for Mycophenolic Acid, Level II 1 x 3 ml 2982 ClinChek Plasma Control, lyophil., for Mycophenolic Acid, Level III 1 x 3 ml 2983 ClinChek Plasma Control, lyophil., for Mycophenolic Acid, Level I, II, III 3 x 3 x 3 ml Homocysteine See title 238 ClinChek Plasma Control, lyophil., for Homocysteine, Level I 1 x 3 ml 2381 ClinChek Plasma Control, lyophil., for Homocysteine, Level II 1 x 3 ml 2382 ClinChek Plasma Control, lyophil., for Homocysteine, Level I, II 2 x 5 x 3 ml Lamotrigine and Sulthiame See title 1518 ClinChek Plasma Control, lyophil., for Lamotrigine and Sulthiame, Level I 1 x 3 ml ClinChek Plasma Control, lyophil., for Lamotrigine and Sulthiame, Level II 1 x 3 ml ClinChek Plasma Control, lyophil., for Lamotrigine and Sulthiame, Level I, II 2 x 5 x 3 ml Trace Elements Ag, Al, As, Au, Be, Bi, Cd, Co, Cr, Cu, Fluoride, Hg, Iodide, Li, Mg, Mn, Mo, Ni, Pd, Pt, Sb, Se, Sn, Tl, V, Zn 8883 ClinChek Plasma Control, lyophil., for Trace Elements, Level I 1 x 3 ml 8884 ClinChek Plasma Control, lyophil., for Trace Elements, Level II 1 x 3 ml 8885 ClinChek Plasma Control, lyophil., for Trace Elements, Level I, II 2 x 5 x 3 ml ClinChek Serum Controls, Lyophilised: Amiodarone Amiodarone, desethylamiodarone 28 ClinChek Serum Control, lyophil., for Amiodarone, Level I 1 x 3 ml 281 ClinChek Serum Control, lyophil., for Amiodarone, Level II 1 x 3 ml 282 ClinChek Serum Control, lyophil., for Amiodarone, Level I, II 2 x 5 x 3 ml ClinChek 2 21

103 Product Survey Antiepileptics Bromide, carbamazepine, carbamazepine-epoxide, N-desmethylmethsuximide, ethosuximide, 1-hydroxy-carbamazepine, oxcarbazepine, PEMA, phenobarbital, phenytoin, primidone, valproic acid 158 ClinChek Serum Control, lyophil., Antiepileptics, Level I 1 x 3 ml 1581 ClinChek Serum Control, lyophil., Antiepileptics, Level II 1 x 3 ml 1582 ClinChek Serum Control, lyophil., Antiepileptics, Level I, II 2 x 5 x 3 ml Felbamate, gabapentine, 1-hydroxy-carbamazepine, lacosamide, lamotrigine, levetiracetam, oxcarbazepine, perampanel, pregabaline, retigabine, rufinamide, stiripentol, sulthiame, tiagabine, topiramate, vigabatrine, zonisamide ClinChek Serum Control, lyophil., Antiepileptics 2, Level I, II 2 x 5 x 2 ml Carbamazepine, carbamazepine-epoxide, ethosuximide, 1-hydroxy-carbamazepine, lamotrigine, oxcarbazepine, phenobarbital, phenytoin, primidone, sulthiame 148 ClinChek Serum Control, lyophil., Antiepileptics 3, Level I 1 x 3 ml 1481 ClinChek Serum Control, lyophil., Antiepileptics 3, Level II 1 x 3 ml 1482 ClinChek Serum Control, lyophil., Antiepileptics 3, Level I, II 2 x 5 x 3 ml N-Desmethylmethsuximide, felbamate, lacosamide, rufinamide, zonisamide 1418 ClinChek Serum Control, lyophil., Antiepileptics 4, Level I 1 x 3 ml ClinChek Serum Control, lyophil., Antiepileptics 4, Level II 1 x 3 ml ClinChek Serum Control, lyophil., Antiepileptics 4, Level I, II 2 x 5 x 3 ml Antiretrovirals Amprenavir, atazanavir, darunavir, delavirdine, efavirenz, etravirine, indinavir, lopinavir, maraviroc, nelfinavir, nevirapine, raltegravir, ritonavir, saquinavir, tipranavir MS482 ClinChek Serum Control, lyophil., for Antiretrovirals, Level I, II 2 x 5 x.5 ml Benzodiazepines Alprazolam, 7-aminoclonazepam, 7-aminoflunitrazepam, 7-aminonitrazepam, bromazepam, chlordiazepoxide, clobazam, clonazepam, demoxepam, desalkylflurazepam, diazepam, estazolam, flunitrazepam, flurazepam, α-hydroxyalprazolam, α-hydroxymidazolam, α-hydroxytriazolam, lorazepam, lormetazepam, medazepam, midazolam, nitrazepam, norclobazam, nordiazepam, norflunitrazepam, oxazepam, prazepam, temazepam, tetrazepam, trazodone, triazolam, zaleplon, zolpidem, zopiclone MS682 ClinChek Serum Control, lyophil., for Benzodiazepines, Level I, II 2 x 5 x 1 ml CDT A-, di-, tri-, tetra-, penta-, hexasialotransferrin 218 ClinChek Serum Control, lyophil., for CDT, Level I 1 x 1 ml 2181 ClinChek Serum Control, lyophil., for CDT, Level II 1 x 1 ml 2182 ClinChek Serum Control, lyophil., for CDT, Level I, II 2 x 5 x 1 ml CSF/Serum Quotients Albumin, glucose, IgA, IgG, IgM, lactate, total protein 865 ClinChek CSF/Serum Control, lyophil., for CSF/Serum Quotients, Level I, II 4 x 2 x 1 ml Drugfree Blank matrix 885 ClinChek Serum Control, lyophil., Drugfree (animal origin) 1 x 1 ml 8851 ClinChek Serum Control, lyophil., Drugfree (human origin) 1 x 5 ml 885B ClinChek Serum Control, frozen, Drugfree (animal origin) 5 ml 8851B ClinChek Serum Control, frozen, Drugfree (human origin) 5 ml Ethylglucuronide Ethylglucuronide, ethylsulfate MS818 ClinChek Serum Control, lyophil., for Ethylglucuronide, Level I 1 x 1 ml MS8181 ClinChek Serum Control, lyophil., for Ethylglucuronide, Level II 1 x 1 ml MS8182 ClinChek Serum Control, lyophil., for Ethylglucuronide, Level I, II 2 x 5 x 1 ml ClinChek 22 23

104 Product Survey Levetiracetam (Keppra ) See title 1558 ClinChek Serum Control, lyophil., for Levetiracetam (Keppra ), Level I 1 x 3 ml ClinChek Serum Control, lyophil., for Levetiracetam (Keppra ), Level II 1 x 3 ml ClinChek Serum Control, lyophil., for Levetiracetam (Keppra ), Level I, II 2 x 5 x 3 ml Psychoactive Drugs TDM 6 Aripiprazole, bupropion, citalopram, desmethylfluoxetine, desmethylsertraline, O-desmethylvenlafaxine, duloxetine, fluoxetine, fluvoxamine, hydroxybupropion, mianserin, mirtazapine, paroxetine, sertindole, sertraline, venlafaxine 8717 ClinChek Serum Control, lyophil., for Psychoactive Drugs TDM6, Level I, II 2 x 5 x 5 ml Methylmalonic Acid See title MS58 ClinChek Serum Control, lyophil., for Methylmalonic Acid, Level I 1 x 2 ml MS581 ClinChek Serum Control, lyophil., for Methylmalonic Acid, Level II 1 x 2 ml MS582 ClinChek Serum Control, lyophil., for Methylmalonic Acid, Level I, II 2 x 5 x 2 ml Trace Elements Ag, Al, As, Au, Ba, Be, Bi, Cd, Co, Cr, Cu, Fe, Fluoride, Hg, Li, Mg, Mn, Mo, Ni, Pd, Pt, Sb, Se, Sn, Tl, V, Zn 888 ClinChek Serum Control, lyophil., for Trace Elements, Level I 1 x 3 ml 8881 ClinChek Serum Control, lyophil., for Trace Elements, Level II 1 x 3 ml 8882 ClinChek Serum Control, lyophil., for Trace Elements, Level I, II 2 x 5 x 3 ml Psychoactive Drugs TDM 1 - TDM 4 Aripiprazole, citalopram, O-desmethylvenlafaxine, 1-hydroxy-carbamazepine, lamotrigine, perazine, quetiapine, venlafaxine 872 ClinChek Serum Control, lyophil., for Psychoactive Drugs TDM1, Level I, II 2 x 5 x 5 ml Amisulpride, O-desmethylvenlafaxine, escitalopram, mirtazapine, quetiapine, venlafaxine 875 ClinChek Serum Control, lyophil., for Psychoactive Drugs TDM2, Level I, II 2 x 5 x 5 ml Clozapine, desmethylclozapine, duloxetine, haloperidol, olanzapine, paliperidone, quetiapine, risperidone, ziprasidone 878 ClinChek Serum Control, lyophil., for Psychoactive Drugs TDM3, Level I, II 2 x 5 x 5 ml Amitriptyline, clomipramine, clozapine, desipramine, desmethylclozapine, doxepin, imipramine, maprotiline, norclomipramine, nordoxepin, nortriptyline, trimipramine 8711 ClinChek Serum Control, lyophil., for Psychoactive Drugs TDM4, Level I, II 2 x 5 x 5 ml Vitamin C See title 288 ClinChek Serum Control, lyophil., for Vitamin C, Level I 1 x.5 ml 2881 ClinChek Serum Control, lyophil., for Vitamin C, Level II 1 x.5 ml 2882 ClinChek Serum Control, lyophil., for Vitamin C, Level I, II 2 x 5 x.5 ml 25-OH Vitamin D2 / D3 25-hydroxy-vitamin D2, 25-hydroxy-vitamin D3 358 ClinChek Serum Control, lyophil., for 25-OH Vitamin D2 / D3, Level I 1 x 2 ml 3581 ClinChek Serum Control, lyophil., for 25-OH Vitamin D2 / D3, Level II 1 x 2 ml 3582 ClinChek Serum Control, lyophil., for 25-OH Vitamin D2 / D3, Level I, II 2 x 5 x 2 ml MS78 ClinChek Serum Control, lyophil., for 25-OH Vitamin D2 / D3, Level I 1 x 1 ml MS781 ClinChek Serum Control, lyophil., for 25-OH Vitamin D2 / D3, Level II 1 x 1 ml MS782 ClinChek Serum Control, lyophil., for 25-OH Vitamin D2 / D3, Level I, II 2 x 5 x 1 ml ClinChek 24 25

105 Product Survey Vitamins All-trans-retinol (vitamin A), alpha-tocopherol (vitamin E), pyridoxal (vitamin B6), pyridoxal-5-phosphate (vitamin B6) 887 ClinChek Serum Control, lyophil., for Vitamins, Level I 1 x 5 ml 8871 ClinChek Serum Control, lyophil., for Vitamins, Level II 1 x 5 ml 8872 ClinChek Serum Control, lyophil., for Vitamins, Level III 1 x 5 ml 8873 ClinChek Serum Control, lyophil., for Vitamins, Level I, II, III 3 x 3 x 5 ml Hemoglobins F / A2 / S Hemoglobin F, hemoglobin A ClinChek Hemolysate Control, ready to use, for Hemoglobins F / A2, Level I, II 2 x 5 x 3 ml Hemoglobin F, hemoglobin A2, hemoglobin S ClinChek Hemolysate Control, ready to use, for Hemoglobins F / A2 / S, Level I 5 x 3 ml ClinChek Whole Blood Controls, Lyophilised / Ready for Use: Acylcarnitines and Amino Acids Analytes: Acetylcarnitine, alanine, arginine, butyrylcarnitine, carnitine, citrulline, decanoylcarnitine, dodecanoylcarnitine, glutamic acid, glutarylcarnitine, glycine, hexadecanoylcarnitine, hexanoylcarnitine, isovalerylcarnitine, leucine, malonylcarnitine, methionine, methylmalonylcarnitine, octadecanoylcarnitine, octanoylcarnitine, ornithine, phenylalanine, propionylcarnitine, tetradecanoylcarnitine, tyrosine, valine 1182 ClinChek Whole Blood Control (filter spot) for Acylcarnitines and Amino Acids, Level I,II 2 x 1 x 3 spots Hemoglobin A1c HbA1c, HbF 118 ClinChek Hemolysate Control, ready to use, for Hemoglobin A1c, Level I 1 x 5 ml 1181 ClinChek Hemolysate Control, ready to use, for Hemoglobin A1c, Level II 1 x 5 ml 1182 ClinChek Hemolysate Control, ready to use, for Hemoglobin A1c, Level I, II 2 x 5 x 5 ml Hemoglobin, free See title 8812 ClinChek Hemoglobin Control, lyophil., for free Hemoglobin, Level I 9 x 1 ml 8813 ClinChek Hemoglobin Control, lyophil., for free Hemoglobin, Level II 9 x 1 ml 8814 ClinChek Hemoglobin Control, lyophil., for free Hemoglobin, Level III 9 x 1 ml 8816 ClinChek Hemoglobin Control, lyophil., for free Hemoglobin, Level I, II, III 3 x 3 x 1 ml 8912 ClinChek Hemoglobin Control (low), lyophil., for free Hemoglobin, Level I 9 x 1 ml 8913 ClinChek Hemoglobin Control (low), lyophil., for free Hemoglobin, Level II 9 x 1 ml 8914 ClinChek Hemoglobin Control (low), lyophil., for free Hemoglobin, Level III 9 x 1 ml 8916 ClinChek Hemoglobin Control (low), lyophil., for free Hemoglobin, Level I, II, III 3 x 3 x 1 ml Homocysteine See title MS2182 ClinChek Whole Blood Control, filter spots, for Homocysteine, Level I, II 2 x 1 x 3 spots Immunosuppressants Cyclosporine A, everolimus, sirolimus, tacrolimus 883 ClinChek Whole Blood Control, lyophil., for Immunosuppressants, Level I 5 x 2 ml 8831 ClinChek Whole Blood Control, lyophil., for Immunosuppressants, Level II 5 x 2 ml 8832 ClinChek Whole Blood Control, lyophil., for Immunosuppressants, Level III 5 x 2 ml 8833 ClinChek Whole Blood Control, lyophil., for Immunosuppressants, Level I, II, III 3 x 2 x 2 ml 893 ClinChek Whole Blood Control, lyophil., for Immunosuppressants, Level IV, V 2 x 2 x 2 ml Trace Elements Ag, As, Cd, Co, Cr, Cu, Hg, K, Mg, Mn, Ni, Pb, Pd, Pt, Se, Tl, Zn 884 ClinChek Whole Blood Control, lyophil., for Trace Elements, Level I 1 x 5 ml 8841 ClinChek Whole Blood Control, lyophil., for Trace Elements, Level II 1 x 5 ml 8842 ClinChek Whole Blood Control, lyophil., for Trace Elements, Level III 1 x 5 ml 8843 ClinChek Whole Blood Control, lyophil., for Trace Elements, Level I, II, III 3 x 3 x 5 ml Vitamins B1, B2, B6 Flavin adenine dinucleotide (FAD), pyridoxal, pyridoxal-5-phosphate (PLP), thiaminepyrophosphate (TPP) 8874 ClinChek Whole Blood Control, lyophil., for Vitamins B1, B2, B6, Level I 1 x 2 ml 8875 ClinChek Whole Blood Control, lyophil., for Vitamins B1, B2, B6, Level II 1 x 2 ml 8876 ClinChek Whole Blood Control, lyophil., for Vitamins B1, B2, B6, Level I, II 2 x 5 x 2 ml ClinChek 26 27

106 HPLC Instruments ClinLab HPLC Instruments Chromatography Software ClinLab HPLC Instruments are intended for the use in analytical laboratories. Our instruments are designed for routine analysis and particularly characterised by user friendliness and robust design. ClinLab HPLC Instruments may be easily combined with modular components from other manufacturers. HPLC Instruments 29

107 HPLC Instruments ClinLab HPLC Instruments Autosampler Autosampler, Model AS Degasser 4-Channel-Degasser, Model DG Detectors Digital Amperometric EC Detector, Model EC Fixed-Wavelength-VIS-Detector for 46 nm, Model FW Universal Detector Cell for Amperometric Detectors, Model Sputnik UV/VIS-Detector, Model UV HPLC-Pumps Isocratic Pump, Model IP Gradient Pump, Model GP HPLC-Thermostats HPLC-Thermostat, Model HT Column Heater, Model CH HPLC Instruments Chromatography Software Clarity TM Software

108 Autosampler Autosampler, Model AS5 Suitable for HPLC vials / microtiter plates Software controlled Suitable for any conventional HPLC System The ClinLab AS5* is a reliable autosampler for routine analysis, using state-of-the-art injection tech - nology. Samples may be handled both using HPLC vials and microtiter plates (2 x 96-well and 384- well). The sample injection is performed within 1 μl increments between - 5 μl and with a minimum carry-over (standard mode: <.5 %, with extra wash: <.1%). The instrument control of the AS5 can be performed with the chromatography software Clarity TM (see pages ). * identical in construction with Spark Holland, model ALIAS TM Specifications General: Sample capacity: 96 samples (2 x 48 vials, 1.5 ml) 192 samples (2 x 96-well, high and low) 384 samples (384-well) Sample dosing: 5 μl syringe, sample loops (1-5 μl) Analytical Performance: RSD: <.3 % (entire filling), <.5 % (partial filling) Linearity:.999 Injection Parameters: Sample volume: - 5 μl in 1 μl steps Needle wash, Loop wash: with solvent / sample Wash mode: every injection / between vials/wells Power Supply, Dimensions, Weight: Power supply: Volt AC, 5-6 Hz Power input: 2 VA Dimensions: 3 x 51 x 36 mm (w x d x h) Weight: 19 kg AS5 ClinLab Autosampler, Model AS5, complete consisting of: Autosampler, power supply cable, serial cable, fuses, user manual Accessories: AS511 Power supply cable AS512 RS232 Serial cable AS521 Fuse 25 V, T 2.5 A FK5 PEEK Starterkit contents: Fingertight fitting, in one piece, 1/16" 5 pcs. Fingertight fitting, in one piece, narrow head, 1/16" 5 pcs. Hex head nut, 1/16" 5 pcs. Double ferrule, 1/16" 5 pcs. Union, 1/16" Tubing, OD: 1:59 mm (= 1/16"), ID:.25 mm, blue 3 m Tubing, OD: 1:59 mm (= 1/16"), ID:.5 mm, orange 3 m ClinLab Plus, cutter and flange tool FK531 Sample loop, PEEK, 1 μl FK532 Sample loop, PEEK, 2 μl FK533 Sample loop, PEEK, 5 μl FK534 Sample loop, PEEK, 1 μl FK535 Sample loop, PEEK, 5 μl FK541 Sample loop, stainless steel, 1 μl FK542 Sample loop, stainless steel, 2 μl FK543 Sample loop, stainless steel, 5 μl FK544 Sample loop, stainless steel, 1 μl FK545 Sample loop, stainless steel, 5 μl HPLC Instruments 213

109 Degasser 4-Channel-Degasser, Model DG4 The ClinLab 4-Channel-Degasser DG4 removes dissolved gases (O 2, N 2, CO 2,...) in a mild but highly efficient way. Solvent degassing increases the de tec - tion sensitivity by improvement of the base line stabi - lity and noise reduction. It prevents the formation of bubbles in the detector cell, in the pump check valves or solvent mixing systems and thus ensures a reliable performance of the whole HPLC system. Since 211 a new instrument series with improved degassing technology and vacuum display is available. Improved technology Specifications RS232 Connection Principle: Vacuum degassing technique. The solvent is passed through a gas permeable membrane tube that is kept at a constant vacuum level (vacuum chamber). DG4 ClinLab 4-Channel-Degasser, Model DG4, complete Suitable for any conventional HPLC system Vacuum Chamber: Degassing capacity:.5 ppm O 2 at.5 ml/min Number of channels: 4 Interior volume per channel: 8 ml Maximum flow rate: 1 ml/min consisting of: degasser with 4 inlet tubings (incl. fittings and ferrules), user manual Accessories: DG411 Power supply cable DG451 Fuse 25 V, T 2. A Vacuum pump: Tube connections: Wetted parts: RS232-Connection: Pressure output signal: membrane pump ID = 1.45 mm; OD = 3 mm PTFE (Teflon) and PEEK YES DG452 Tubing with fitting and ferrule, 1m, OD: 3 mm HPLC Instruments Error output signal: YES Power Supply, Dimensions, Weight: Power supply: 23 V / 11 V, 5 / 6 Hz Dimensions: 26 x 51 x 16 mm (w x d x h) Weight: 11.5 kg 215

110 Detectors Digital Amperometric EC Detector, Model EC3 The EC3 is a highly sensitive electrochemical detector for analytical HPLC. The instrument allows for detection of substances down to the lower picogram range. For the use in routine analysis, the EC3 features easy handling and provides a multitude of functions for automatisation. The basic equipment of the EC3 includes the detector cell EC4, model Sputnik (see pages ). High detection sensitivity Specifications Principle: Easy handling Amperometric detector with three-electrode technique Detector Cell: ECD cell EC4, model Sputnik (s. p ) Electronics: Detector cell Sputnik included Cost efficient Working potential: ± 2. V Measurement range: ± (1 pa - 2 μa) Auto-Zero range: max ± 5 μa Manual offset range: max ± 5 μa LCD-display: display of settings and measurement data Filter: 5 Hz -.2 Hz (.2-5 sec) Detector noise level: <.3 pa Cleaning potential: ± 2. V Cleaning duration: 1-1 sec Delay time before applying cleaning pot.: 1-15 sec Cleaning cycle: every 1st to 1th cycle EC3 ClinLab Digital Amperometric Detector, Model EC3, complete consisting of: Digital electronic unit, power supply, cell-, signal- and autozero-cable, complete cell, installed in cell housing, ready-to-use, user manual Accessories: EC4 ClinLab ECD cell, Model Sputnik, complete consisting of: cell, tubings, fittings, glassy carbon working electrode, gaskets, reference electrode, wrenches, 3 M KCl, manual HPLC Instruments Storage capacity for measurement progr.: - 99 Storage capacity for cell-cleaning progr.: - 99 Analogue output: ± 1 V per measurem. range EC41 ClinLab Accessory Kit for ECD cell, Model Sputnik consisting of: tubings, fittings, glassy carbon working electrode, gaskets, reference electrode, wrenches, 3 M KCl, in assortment box For spareparts of the cell see page 221! Auto-zero interface: active low, switching contact, active high, curr./volt. input Power supply: input: V, 5-6 Hz output: 12 V DC, 2.5 A Dimensions, Weight: EC311 Power supply EC312 Multiple shielded cell-cable for cell EC4, Model Sputnik EC313 Autozero-cable with universal-terminals EC314 Autozero-cable with HITACHI-connector EC113 BNC-cable for analog-output with universal-terminals EC114 BNC-cable for analog-output with HITACHI-connector Dimensions: 26 x 51 x 16 mm (w x d x h) Weight: 7.6 kg 217

111 Detectors Fixed-Wavelength- VIS-Detector (46 nm), Model FW3 The FW3 is designed for a reliable and sensitive analyte detection at 46 nm. The detector noise level is at ±5 μau and thus enables an excellent detection limit. The FW3 features easy handling and maintenance at a most favourable price. The instrument can be controlled via the DataApex Chromatography Software Clarity TM (see pages ). High detection sensitivity Specifications Easy handling and maintenance Cost efficient Principle: Single beam principle Optics: Light source: LED Wavelength: 46 nm Spectral half-width: 12 nm Measurement Cell: Cell volume: 1 μl ID of capillary inlet:.2 mm Optical path length: 5 mm Electronics: Measurement range: -.1 AU analogue - 4 AU digital Detector noise level: ±.5 x 1-5 AU Time constant: fast, middle and slow Drift (empty cell): 2 x 1-4 AU/h Analogue output: 1 V/AU Digital output: 1 V/AU Data interface: RS232 FW3 ClinLab Fixed-Wavelength-VIS-Detector (46 nm), Model FW3, complete consisting of: Digital electronic unit, detector cell, test cell, power supply cable, signal cable (analogue output), autozero-cable, hydrodynamic restrictor, fuses, adapters, user manual Accessories: FW311 Power supply cable FW312 Signal cable (analogue output) FW313 Autozero-cable with core cable ends FW314 Autozero-cable with Hitachi-connector FW321 Fuse 23 V, T 1A FW331 Detector cell FW332 Test cell FW333 Hydrodynamic restrictor FW334 Lamp replacement HPLC Instruments Power supply: 1 / 115 / 23 V, 5-6 Hz Power input: 8 VA Miscellaneous: Wetted parts: Vespel, fused silica, stainless steel Dimensions, Weight: Dimensions: 22 x 46 x 18 mm (w x d x h) Weight: 7.2 kg 219

112 Detectors Universal Detector Cell for Amperometric Detectors, Model Sputnik The detector cell EC4, model Sputnik is suitable for all conventional* amperometric detectors. The cell enables a high detection sensitivity (see EC3, pages ) and features optimal handling, easy maintenance and a most favourable price. * e.g.: RECIPE, Merck, Antec, Waters, Pharmacia, BioRad High detection sensitivity Specifications Easy handling and maintenance Working Electrode: Glassy carbon in zirconium oxide Auxiliary Electrode: Stainless steel Reference Electrode: Ag/AgCl reference electrode with Kel-F housing, refillable EC4 ClinLab ECD cell, Model Sputnik, complete consisting of: cell, tubings, fittings, glassy carbon working electrode, gaskets, reference electrode, wrenches, 3 M KCl, manual Cost efficient Diaphragm: Base-stable zirconium oxide diaphragm Cell Volume: 1.5 μl with 3 μm spacer Materials: Stainless steel, PTFE, PEEK, zirconium oxide, glassy carbon, Kel-F Dimensions (w x d x h): Housing: 12 x 11 x 15 mm Cell: 4 x 4 x 8 mm Accessories: EC41 ClinLab Accessory Kit for ECD cell, Model Sputnik consisting of: tubings, fittings, glassy carbon working electrode, gaskets, reference electrode, wrenches, 3 M KCl, in assortment box EC117 Cell cable for Merck/RECIPE-Detector L-35A EC118 Cell cable for Antec-Detector EC119 Cell cable for ECD (Waters, Pharmacia) EC1113 Adapter Set for BioRad-Detector EC211 Glassy carbon working electrode EC242 Cell gasket 3 μm 3 pcs. EC421 Reference electrode, complete EC431 Cell top EC432 Cell body EC433 Compression screw complete with compression disc and contact pin EC434 Wrench for compression screw EC435 Allen wrench 1.5 mm EC451 Tubing set (inlet tubing PEEK.25 mm x 1 cm, blue outlet tubing PEEK.5 mm x 1 cm, orange) EC463 Cell housing with mounting device EC464 Mounting device for RECIPE-detector EC3 EC465 Mounting device for ECD (Waters, Pharmacia) EC48 Cell top (exchange) EC29 3 M KCl-Solution 5 ml HPLC Instruments 221

113 Detectors UV/VIS-Detector, Model UV3 The ClinLab UV/VIS-Detector enables a sensitive detection (noise level ±.5 x 1-5 AU) with a vari - able wavelength in a range between 19-6 nm. During analysis, the detection wavelength can be easily switched and thus allows for the determination at different wavelengths within the same analytical series. For use in the routine laboratory, the UV3 features robustness and user-friendliness (e.g. de - tec tor diagnosis, easy changing of the detector lamp). The instrument can be controlled via the DataApex High detection sensitivity Chromatography Software Clarity TM ). (see pages Variable wavelength: 19-6 nm Suitable for any conventional HPLC system Specifications Principle: Variable wavelength UV/VIS-Detector Optics: Light source: Deuterium-Lamp Wavelength range: 19-6 nm Precision: ± 1 nm Reproducibility: ±.5 nm Spectral half-width: 6 nm Measurement Cell: Cell volume: 1 μl Optical path length: 5 mm Electronics: Detector noise: ±.5 x 1-5 AU Time constant: fast (.4 sec), middle (1 sec), slow (5 sec) Drift (empty cell): 1 x 1-4 AU/h UV3 ClinLab UV/VIS-Detector, Model UV3, complete consisting of: Digital electronic unit, detector cell, test cell, power supply cable, signal cable (analogue output), autozero cable, hydrodynamic restrictor, fuses, adapters, fittings, user manual Accessories: UV311 Power supply cable UV312 Signal cable (analogue output) UV313 Autozero-cable UV314 CINCH-connector 2xV (male-male) UV321 Fuse 25 V, T.8 A UV322 Fuse 25 V, T 1 A UV323 Fuse 25 V, T 2 A 2 pcs. UV331 Detector cell UV332 Test cell UV333 Hydrodynamic restrictor HPLC Instruments Output: 1 V / AU (analogue) UV341 Deuterium lamp Offset / Interface: ± 5 mv / RS232 Miscellaneous: Wetted parts: stainless steel, fused silica, vespel Power Supply, Dimensions, Weight: UV351 Union, 1/16ʼʼ 2 pcs. UV352 Nut, 1/16ʼʼ 2 pcs. UV353 Ferrule, 1/16ʼʼ 2 pcs. UV354 Fingertight fitting, in one piece, 1/16ʼʼ 2 pcs. UV355 PFTE-tubing: OD: 2 mm, ID: 1.5 mm.5 m UV356 Luer adapter 2 pcs. Power supply: 11 / 115 / 23 V, 5 / 6 Hz Power input: 55 VA Dimensions: 26 x 49 x 17 mm (w x d x h) Weight: 11 kg 223

114 HPLC-Pumps Isocratic Pump, Model IP3 The ClinLab isocratic HPLC pump IP3 is designed to fulfill the requirements of routine analysis. The pump ensures a reliable, accurate and stable buf - fer delivery at any flow rate between.1-1 ml/min. The robust instrument allows for a maximum column backpressure of 4 bar. The IP3 can be operated with any conventional HPLC sys tem. The ins - trument can be controlled via the DataApex Chro ma - tography Software Clarity TM (see pages ). Safe, accurate and stable buffer delivery Robust design Specifications General: Isocratic dual piston (1/8ʼʼ) HPLC pump with electronic pulse compensation. Flow Rates, Pressures: Flow rates:.1-1 ml/min (in.1 steps) -Precision: ± 1 % -Accuracy: ± 2 % Max. operating pressure: 4 bar Precision of pressure measurement: ± 2 % Electronics: Interface: RS232 Miscellaneous: Wetted parts: stainless steel, PTFE, PEEK, saphire Power Supply, Dimensions, Weight: Power supply: 11 / 115 / 23 V, 5 / 6 Hz Power input: 3 VA Dimensions: 26 x 49 x 17 mm (w x d x h) Weight: 8.5 kg IP3 ClinLab HPLC-Pump, isocratic, Model IP3, complete consisting of: Pump, power supply cable, fuses, inlet tubing incl. fittings, syringe, waste tubing, user manual Accessories: IP311 Power supply cable IP312 RS232 serial cable IP321 Fuse 25 V, T 4 A IP322 Fuse 25 V, T 1 A IP323 Fuse 25 V, T.5 A IP331 Inlet tubing, OD: 1/8", ID: 1/16", 1m IP332 Waste tubing with adapter IP331 Plastic syringe 2 ml IP341 Piston IP342 Piston seal IP343 Piston rear washing set 1 set IP344 Washing seal IP353 Inlet/outlet valve cartridge FK5 PEEK Starterkit contents: Fingertight fitting, in one piece, 1/16" 5 pcs. Fingertight fitting, in one piece, narrow head, 1/16" 5 pcs. Hex head nut, 1/16" 5 pcs. Double ferrule, 1/16" 5 pcs. Union, 1/16" Tubing, OD: 1.59 mm (=1/16"), ID:.25 mm, blue 3 m Tubing, OD: 1.59 mm (=1/16"), ID:.5 mm, orange 3 m ClinLab Plus, cutter and flange tool HPLC Instruments 225

115 HPLC-Pumps Gradient Pump, Model GP3 Precise ternary gradients Safe, accurate and stable buffer delivery Robust design The ClinLab GP3 is a ternary HPLC gradient pump designed to meet the requirements in labo - ra tory analysis. The pump provides the selected elu ent composition, either isocratic or as ternary gradient. In routine analysis, the GP3 facilitates storage of up to 1 different gradient programs, the corresponding data files can be imported via RS232 interface. The GP3 can be controlled via the DataApex Chromatography Software Clarity TM (see pages ). Specifications General: Dual piston (1/8ʼʼ), ternary low pressure gradient HPLC pump. Flow Rates, Pressures: Flow rates (in.1 steps): gradient mode:.1-3 ml/min isocratic mode:.1-1 ml/min -Precision: ± 1 % -Accuracy: ± 2 % Max. op. pressure: 4 bar Gradient Elution: Number of valves: 3 (A, B, C) Setting of components A, B, C: - 1 % (in 1 % steps) Gradient programs: up to 1 Gradient sections per program: up to 5 Electronics: Interface: RS232 Miscellaneous: Wetted parts: stainless steel, PTFE, PEEK, saphire Power Supply, Dimensions, Weight: Power supply: 11 / 115 / 23 V, 5 / 6 Hz Power input: 5 VA Dimensions: 26 x 49 x 17 mm (w x d x h) Weight: 9 kg GP3 ClinLab Gradient HPLC-Pump, Model GP3, complete consisting of: Pump, power supply cable, fuses, inlet tubing incl. fittings, syringe, waste tubing, start-signal cable, user manual Accessories: GP311 Power supply cable GP312 RS232 serial cable GP321 Fuse 25 V, T 4 A GP322 Fuse 25 V, T 1 A GP323 Fuse 25 V, T.5 A GP331 Inlet tubing, OD: 1/8", ID: 1/16", 1m GP332 Waste tubing with adapter GP331 Plastic syringe 2 ml GP341 Piston GP342 Piston seal GP343 Piston rear washing set 1 set GP344 Washing seal GP353 Inlet/outlet valve cartridge FK5 PEEK Starterkit contents: Fingertight fitting, in one piece, 1/16" 5 pcs. Fingertight fitting, in one piece, narrow head, 1/16" 5 pcs. Hex head nut, 1/16" 5 pcs. Double ferrule, 1/16" 5 pcs. Union, 1/16" Tubing, OD: 1.59 mm (=1/16"), ID:.25 mm, blue 3 m Tubing, OD: 1.59 mm (=1/16"), ID:.5 mm, orange 3 m ClinLab Plus, cutter and flange tool HPLC Instruments 227

116 HPLC-Thermostat HPLC-Thermostat, Model HT4 The ClinLab HPLC-Thermostat HT4 establishes the basis for optimised and standardised detection. All HPLC components which influence the chro ma - to graphic separation, from injection valve to ECdetector cell, are temperature controlled (1-6 C). The thermostat chamber provides room for several columns as well as for the detector cell EC4 (see pages ). The HT4 can be controlled via the DataApex Chromatography Software Clarity TM (see pages ). Temperature control from 1-6 C Detector cell EC4 installable Specifications Principle: Microprocessor-controlled peltier heating/cooling. Forced air concept for homogenous temperature distribution and quick temperature adjustment. Thermostat Chamber: Temperature control range: 1 C - 6 C Temperature control accuracy: ±.5 C HT4 ClinLab HPLC-Thermostat, Model HT4, complete consisting of: HPLC-Thermostat, power supply cable, fuse, mounting device for ClinLab ECD cell, model Sputnik, user manual Cost efficient Temperature constancy: ±.15 C Safety in Operation: The HT4 is equipped with a gas sensor and an automatic shut-down in case of failure. Power Supply, Dimensions: Power supply: 1-24 V, 5-6 Hz Power input: 19 VA Housing dimensions: 26 x 49 x 22 mm (w x d x h) Thermostat chamber dimensions: 1 x 44 x 12 mm Accessories: HT411 Power supply cable HT412 RS232 Serial cable HT413 Multiple shielded cell-cable for cell EC4, model Sputnik and EC-detector, modell EC3 HT414 Cell cable for cell EC4, model Sputnik and EC-detector, model L-35A HT421 Fuse 25 V, 3.15 A HT422 Fuse 25 V, 16 A HT451 Waste tubing FK1 Manual injection valve Rheodyne 7725i, complete FK15 Manual injection valve Rheodyne 9725i (PEEK), complete HPLC Instruments (w x d x h) FK511 Fingertight fitting, in one piece, 1/16" 5 pcs. FK512 Fingertight fitting, in one piece, narrow head, 1/16" 5 pcs. FK521 Tubing, OD: 1.59 mm (= 1/16"), ID:.17 mm, yellow 3 m FK522 Tubing, OD: 1.59 mm (= 1/16"), ID:.25 mm, blue 3 m FK523 Tubing, OD: 1.59 mm (= 1/16"), ID:.5 mm, orange 3 m 229

117 HPLC-Thermostat Column Heater, Model CH3 The ClinLab Column Heater, Model CH3, is designed for a thermostatisation at temperatures between ambient temperature and 1 C and provides space for two HPLC columns. The instrument can be controlled via the DataApex Chro ma to gra - phy Software Clarity TM (see pages ). Specifications Principle: Microprocessor-controlled heating. Temperature control from ambient temperature to 1 C Heating Chamber: Temperature control range: from the actual ambient temperature to 99.9 C Temperature control accuracy: ±.5 C Temperature constancy: ±.1 C CH3 ClinLab Column Heater, Model CH3, complete RS232 interface Cost efficient Heating rate: 5 C/min Power Supply, Dimensions, Weight: Power supply: 1 / 115 / 23 V ± 1 %, 5 / 6 Hz Weight: 8.5 kg Housing dimensions: 26 x 49 x 16 mm (w x d x h) Heating block: 34 x 31 x 27 mm (w x d x h) consisting of: Column heater, power supply cable, fuses, user manual Accessories: CH311 Power supply cable CH312 RS232 Serial cable CH321 Fuse 25 V, T 1.25 A CH322 Fuse 25 V, T 2.5 A FK511 Fingertight fitting, in one piece, 1/16" 5 pcs. FK512 Fingertight fitting, in one piece, narrow head, 1/16" 5 pcs. FK521 Tubing, OD: 1.59 mm (= 1/16"), ID:.17 mm, yellow 3 m FK522 Tubing, OD: 1.59 mm (= 1/16"), ID:.25 mm, blue 3 m FK523 Tubing, OD: 1.59 mm (= 1/16"), ID:.5 mm, orange 3 m HPLC Instruments 231

118 Chromatography Software Several of our ClinLab HPLC Instruments can be used with the chromatography software Clarity from DataApex. Clarity is suitable for the control of the HPLC-system, for data acquisition, and data evaluation. RECIPE is an authorised Clarity -Trainingscenter in Germany. We provide a 1 day intensive course (see order no. SW19) were we give all essential knowledge for software handling. Software: SW1 Software-Packet Clarity consisting of: basic software module, 2 control modules, A/D-converter (2-channel) (for data aquisition and chromatography evaluation*, as well as for controlling an HPLC-system) SW11 Basic Software Module Clarity (for data aquisition and chromatography evaluation*) Software-extension modules: SW121 Module for an additional HPLC-system SW122 Module for system suitability tests Control modules: SW131 Control module for HPLC-instruments like pump, detector, etc. SW132 Control module for Autosampler Hardware: SW164 A/D-converter (USB), 2-channel, incl. cable SW165 A/D-converter (USB), 4-channel, incl. cable SW1612 USB-RS232 Adapter SW1613 Multicom-Converter (1 x USB to 6 x RS232) SW171 RS232 Serial cable SW19 Clarity Training 1 day course * For controlling HPLC-instruments, corresponding RS232 serial cables and RS232 serial ports, as well as free USB ports are required in the PC; please note hardware-requirements! HPLC Instruments Hardware-Requirements with operating system: Windows XP/2: minimum: Pentium III/7 MHz, 256 MB RAM recommended: Pentium 4/2 GHz, 512 MB RAM with operating system: Windows Vista, Windows 7 / 8: identical with requirements for operating system Monitor: minimum: resolution 124 x 768, 64K recommended: resolution 128 x 124, 64K free USB ports, CD-ROM drive Clarity is a registered trademark of DataApex

119 HPLC Accessories ClinRep Reagents for Chromatography ClinLab HPLC Accessories HPLC Accessories 235