Simplifying your quality controls. Thermo Scientific MAS Quality Control Products LabLink xl Quality Assurance Program. North American version

Transcription

1 Simplifying yor qality controls Thermo Scientific MAS Qality Control Prodcts LabLink xl Qality Assrance Program North American version

2 Experience or qality Improve yor reslts

3 Contents Thermo Scientific MAS Controls Omni Consolidated Controls 4-7 Serm Chemistries 8-9 Urine Chemistries Immnoassay Cardiac & Diabetes 14 Immnology & Protein 15 Toxicology 16 Dimension Vista Controls Thermo Scientific MAS Programs LabLink xl Qality Assrance Software Vale Assignment Program 28 Thermo Scientific MAS Control References Instrments General Ordering Information To Place An Order 39 Technical Service & Spport 39

4 Thermo Scientific MAS Omni Controls 4

5 Streamline yor workflow Consolidate mltiple QC prodcts Omni CARDIO Thermo Scientific MAS Omni CARDIO Controls consolidate a comprehensive cardiac marker panel with the new generation of STAT analytes inclding D-Dimer, hcg, Myeloperoxidase and Procalcitonin. Vale assignment is provided for key instrment systems inclding Abbott Architect, Beckman Colter Access, AU and UniCel systems, Ortho Clinical Diagnostics VITROS, Roche Cobas and Elecsys systems and Siemens Advia, Dimension, Dimension Vista, Immlite and Strats systems. Part Nmber Level Bottles & Size Storage & Stability Matrix OCRD-UL Ultra Low OCRD-L Low OCRD OCRD OCRD OCRD-MP Tri-Level Mlti-Pack (2 vials each level 1/2/3) 6 x 3 ml Assayed to -15 ºC ºC (for BNP-32, CK-MB, D-Dimer, Digitoxin, hcg, hscrp, Myeloperoxidase, Procalcitonin, Total CK, Troponin-I and Troponin-T) ºC (for Myoglobin and NT-proBNP) Hman Serm Brain Natriretic Peptide-32 (BNP-32) Creatinine Kinase-MB (CK-MB) D-Dimer Digitoxin Hman Chorionic Gonadotropin (hcg) Beta Hman Chorionic Gonadotropin (Beta-HCG) High Sensitivity C-Reactive Protein (hscrp) Myeloperoxidase (MPO) Myoglobin N-Terminal Brain Natriretic Peptide (NT-proBNP) Procalcitonin (PCT) Total Creatinine Kinase (Total CK) Troponin I Troponin T Refer to package insert for specific analyte, stability claims, and limitations of procedres. Shelf life starts from the date of manfactre. Availability of prodcts in each contry depends on local reglatory marketing athorization stats. 5

6 Thermo Scientific MAS Omni Controls Omni CORE Thermo Scientific MAS Omni CORE Controls consolidate general chemistry and serm protein QC processing into a single prodct, offering three distinct levels. Vale assignment is provided for key integrated instrment systems, inclding Abbott Architect, Beckman Colter AU, Synchron and UniCel, Ortho Clinical Diagnostics Vitros, Roche Cobas and Elecsys systems and Siemens Advia, Dimension and Dimension Vista. Part Nmber Level Bottles & Size Storage & Stability Matrix OCR month shelf -25 to -15 ºC OCR x 5 ml Assayed 30 days open 2 to 8 ºC Hman Serm OCR (Bilirbin is 15 days open 2 to 8 ºC) General Chemistry Albmin Alkaline Phosphatase (ALT/GPT) Alanine Aminotransferase (ALT) Amylase Amylase (Pancreatic)* Aspartate Aminotransferase (AST/GOT) Bile Acids* Bilirbin, Conjgated Bilirbin, Direct (DBIL) Bilirbin, Neonatal Bilirbin, Total (TBIL) Bilirbin, Unconjgated Blood Urea Nitrogen (BUN) Calcim Carbon Dioxide (CO2) Chloride Cholesterol Cholesterol, HDL Cholesterol, LDL Copper* Creatine Kinase (CK) Creatinine Gamma-Gltamyl Ttransferase (GGT) Glcose Lactate Dehydrogenase (LDH) Lactic Acid Lipase Magnesim Osmolality Phosphors Potassim Psedocholinesterase (PCHE) Sodim Total Protein Triglycerides Uric Acid Zinc TDM/Toxicology Tests Acetaminophen Amikacin Caffeine Carbamazepine Digoxin Disopyramide Ethanol Ethosximide Gentamicin Lidocaine Lithim Methotrexate N-acetylprocainamide (NAPA) Phenobarbital Phenytoin Primidone Procainamide Qinidine Salicylate Theophylline Tobramycin Tricyclic Antidepressants (TCA) Valproic Acid Vancomycin Anemia/Iron Deficiency Tests Ferritin Iron Iron Binding Capacity (IBC) Iron Binding Capacity, Total (TIBC) Iron Binding Capacity, Unsatrated (UIBC) Transferrin* Thyroid Fnction Tests Thyroxine, Total (TT4) Thyroid-Stimlating Hormone (TSH) Thyroid Uptake (T-Uptake) Endocrine/Hormone Tests Cortisol Allergy Tests Immnogloblin E (IgE) Serm Proteins/Serology Tests Alpha-1-Acid Glycoprotein (AAG)* Alpha-1-Antitrypsin (AAT)* Alpha-2-Macrogloblin (AMG)* Antistreptolysin O (ASO) Apolipoprotein A1 (APO A)* Apolipoprotein B (APO B)* Beta-2-Microgloblin C3 Complement* C4 Complement* Cerloplasmin (CER)* C-Reactive Protein (CRP) Haptoglobin* Immnogloblin A (IgA)* Immnogloblin G (IgG)* Immnogloblin M (IgM) Lipoprotein A (Lp(a))* Prealbmin Rhematoid Factor (RF) * These constitent levels have not been adjsted bt are at levels fond in the sorce material sed in preparation of the controls. No claim is made for expected vales of these constitents. Refer to package insert for specific analyte, stability claims, and limitations of procedres. Shelf life starts from the date of manfactre. Availability of prodcts in each contry depends on local reglatory marketing athorization stats. 6

7 Omni IMMUNE Thermo Scientific MAS Omni IMMUNE & Omni IMMUNE PRO Controls provide consolidation for rotine immnoassay, tmor marker and specialty immnoassay QC processing into a single prodct, offering three distinct levels. Vale assignment is provided for key integrated instrment systems inclding Abbott Architect, Beckman Colter Access and UniCel, Ortho Clinical Diagnostics Vitros, Roche Cobas and Elecsys systems and Siemens Centar, Dimension, Dimension Vista and Immlite. Part Nmber Level Bottles & Size Storage & Stability Matrix OIM OIM OIM x 5 ml Assayed 36 month shelf -25 to -15 ºC 30 days open 2 to 8 ºC Hman Serm Omni IMMUNE PRO Thermo Scientific MAS Omni IMMUNE PRO Controls provide Anti-Thyrogloblin (Anti-Tg), Anti-Thyroid Peroxidase (Anti-TPO) and Sex Hormone Binding Globlin (SHBG), in addition to the same analyte panel provided in the MAS Omni IMMUNE prodct. Part Nmber Level Bottles & Size Storage & Stability Matrix OPRO OPRO OPRO x 5 ml Assayed 36 month shelf -25 to -15 ºC 30 days open 2 to 8 ºC Hman Serm New Specialty Tests 25-Hydroxy Vitamin D Anti-Thyrogloblin (Anti-Tg) (PRO) Anti-Thyroid Peroxidase (Anti-TPO) (PRO) C-Peptide Estriol, Free Frctosamine* IGF-1 (inslin-like growth factor 1) Phenytoin, Free Pregnancy Associated Plasma Protein A (PAPP-A)* Procalcitonin Parathyroid Hormone (PTH) Sex Hormone-Binding Globlin (SHBG) (PRO) Thyroxine-Binding Globlin (TBG) Valproic Acid, Free TDM/Toxicology Tests Acetaminophen Amikacin Benzodiazepine (Nordiazepam) Carbamazepine Digoxin Disopyramide Ethosximide Gentamicin Lidocaine Lithim N-acetylprocainamide (NAPA) Phenobarbital Phenytoin Primidone Procainamide Qinidine Salicylate Theophylline Tobramycin Tricyclic Antidepressants (TCA) Valproic Acid Vancomycin Thyroid Fnction Tests Triiodothyronine, Free (FT3) Triiodothyronine, Total (TT3) Thyroxine, Free (FT4) Thyroxine, Total (TT4) Thyrogloblin Thyroid-Stimlating Hormone (TSH) Thyroid Uptake (T-Uptake) Tmor Marker Tests Adrenocorticotropic Hormone (ACTH) Beta-2-microgloblin CA 125 CA 15-3 CA 19-9 Carcinoembryonic Antigen (CEA) Gastrin Prostatic Acid Phosphatase (PAP) Prostate Specific Antigen, Free (FPSA) Prostate Specific Antigen, Total (TPSA) Reprodctive/Fertility Tests 17-alpha-OH-progesterone Alpha-fetoprotein Estradiol Follicle Stimlating Hormone (FSH) Hman Chorionic Gonadotropin (hcg) Beta Hman Chorionic Gonadotropin (β-hcg) Leteinizing Hormone (LH) Progesterone Prolactin Testosterone Endocrine/Hormone Tests Aldosterone Calcitonin* Cortisol DHEA Slfate Growth Hormone Inslin* Cardiac Tests Homocysteine Anemia/Iron Deficiency Tests Ferritin Folate (vitamin B9) Vitamin B12 Allergy Tests Immnogloblin E (IgE) * These constitent levels have not been adjsted bt are at levels fond in the sorce material sed in preparation of the controls. No claim is made for expected vales of these constitents. Refer to package insert for specific analyte, stability claims, and limitations of procedres. Shelf life starts from the date of manfactre. Availability of prodcts in each contry depends on local reglatory marketing athorization stats. Dropper Tips - Pkg MAS P/N

8 Thermo Scientific MAS Serm Chemistry Controls MAS chemtrak H This is a comprehensive mlti-analyte control, designed to monitor general chemistry and TDM methods. Available in an assayed or nassayed format. Both formats are liqid, ready-to-se and no additional preparation is reqired. Assayed vales are available for most major platforms. Part Nmber Level Bottles & Size Storage & Stability* Matrix CHA x 5 ml Assayed 30 month shelf -25 to -15 ºC CHA-2 2 CHA-3 3 CHU-1 1 CHU-2 2 CHU x 15 ml Unassayed 14 days 2 to 8 ºC; nassayed 7 days 2 to 8 ºC; assayed Hman Serm Acetaminophen Alanine Aminotransferase (ALT) Albmin Alkaline Phosphatase Amikacin Amylase Amylase (Pancreatic) Apolipoprotein A Apolipoprotein B Aspartate Aminotransferase (AST) Bilirbin Unconjgated Bilirbin, Conjgated Bilirbin, Direct (DBIL) Bilirbin, Neonatal Bilirbin, Total (TBIL) Blood Urea Nitrogen (BUN) C3 Complement* C4 Complement* Caffeine Calcim Carbamazepine Carbon Dioxide (CO2) Chloride Cholesterol Creatine Kinase (CK) Creatinine Digoxin Disopyramide Ethanol Ethosximide Ferritin* Gamma-Gltamyl Transferase Gentamicin GLDH* Glcose Haptoglobin* HBDH* HDL Cholesterol Immnogloblin A (IgA)* Immnogloblin G (IgG)* Immnogloblin M (IgM)* Iron Iron Binding Capacity, Total (TIBC) Iron Binding Capacity, Unsatrated (UIBC)* Lactate Dehydrogenase (LDH) Lactic Acid LDL Cholesterol Lidocaine Lipase Lipoprotein (a) Lithim Magnesim Methotrexate N-acetylprocainamide (NAPA) Osmolality Phenobarbital Phenytoin Phosphors Potassim Prealbmin Primidone Procainamide Psedocholinesterase Qinidine Salicylate Sodim Theophylline Thyroid Stimlating Hormone Thyroid Uptake (T-Uptake) Thyroxine, Free (FT4)* Thyroxine, Total (TT4) Tobramycin Total Protein Transferrin* Tricyclic Antidepressants Triglycerides Triiodthyronine, Free (FT3)* Triiodthyronine, Total (TT3)* Uric Acid Valproic Acid Vancomycin * These constitent levels have not been adjsted bt are at levels fond in the sorce material sed in preparation of the controls. No claim is made for expected vales of these constitents. Refer to package insert for specific analyte, stability claims, and limitations of procedres. Shelf life starts from the date of manfactre. Availability of prodcts in each contry depends on local reglatory marketing athorization stats. Dropper Tips - Pkg MAS P/N

9 MAS Alcohol/Ammonia An assayed, bi-level control for monitoring ethanol and ammonia levels in serm. This ready-to-se prodct is packed in convenient mltipacks and has been assayed for most major instrments. Normal Ammonia vales in Level 1. Part Nmber AAC-MP Level Bottles & Size Storage & Stability Matrix Bi-level, Mlti-Pack 6 x 3.5 ml 24 month shelf 2 to 8 ºC 30 days 2 to 8 ºC Hman Serm Ammonia Ethanol MAS Bilirbin This assayed, tri-level control has been designed to monitor the performance of total, direct, conjgated, nconjgated and neonatal bilirbin. There are no additional preparation steps reqired for this liqid, ready-to-se prodct. An elevated Bilirbin is inclded in level 3 for neonatal applications. Part Nmber Level Bottles & Size Storage & Stability Matrix BC month shelf 2 to 8 ºC BC x 5 ml 14 days 2 to 8 ºC Bovine Serm BC103 3 when stored in the dark Bilirbin, Conjgated Bilirbin, Direct (DBIL) Bilirbin, Neonatal Bilirbin, Total (TBIL) Bilirbin, Unconjgated Refer to package insert for specific analyte, stability claims, and limitations of procedres. Shelf life starts from the date of manfactre. Availability of prodcts in each contry depends on local reglatory marketing athorization stats. Dropper Tips - Pkg MAS P/N

10 Thermo Scientific MAS Urine Chemistry Controls MAS UA Control A bi-level control that is liqid and ready-to-se with improved room temperatre storage capability. This rine control was designed for monitoring rine dipstick and microscopic components and is assayed for most major reagent strips and strip systems. It incldes ten commonly tested dipstick tests pls Microalbmin, Creatinine and hcg. Part Nmber Level Bottles & Size Storage & Stability Matrix UAB x 15 ml UAB-160 (normal) 4 x 60 ml 24 month shelf 2 to 8 ºC UAB x 15 ml Open Vial: Hman UAB-260 (abnormal) 4 x 60 ml Refrigerated 3 2 to 8 C Urine UAB-MP Bi-level, Room temperatre 6 18 to 25 C 6 x 15 ml Mlti-Pack Bilirbin Blood Creatinine Crystals Glcose Hman Chorionic Gonadotropin (hcg) Ketones Lekocyte Esterase Microalbmin Nitrite Osmolality ph Potassim Protein Protein-to-creatinine ratio Red Blood Cells Sodim Specific Gravity Urobilinogen White Blood Cells MAS UA DipTbe MAS UA prodct packed into convenient dip tbes to simplify manal testing of rinalysis strips. Part Nmber UAT-MP Level Bottles & Size Storage & Stability Matrix Bi-level, Mlti-Pack 10 x 12 ml 24 months shelf 2 to 8 ºC Open Vial: Refrigerated 8 weeks or 20 2 to 8 ºC Room temp 2 weeks or to 30 ºC MAS Urinalysis A bi-level rine control designed for monitoring rine dipstick and microscopic components. This liqid control is assayed for most major reagent strips and strip systems. Hman Urine Part Nmber Level Bottles & Size Storage & Stability Matrix x 15 ml 12 month shelf 2 to 8 ºC (abnormal) 4 x 60 ml 30 days 2 to 8 ºC Hman x 15 ml 18 month shelf 2 to 8 ºC Urine (normal) 4 x 60 ml 30 days 2 to 8 ºC Refer to package insert for specific analyte, stability claims, and limitations of procedres. Shelf life starts from the date of manfactre. Availability of prodcts in each contry depends on local reglatory marketing athorization stats. Bilirbin Blood Creatinine Crystals Glcose Hman Chorionic Gonadotropin (hcg) Ketones Lekocyte Esterase Microalbmin Nitrite Bilirbin Blood Creatinine Crystals Glcose Hman Chorionic Gonadotropin (hcg) Ketones Lekocyte Esterase Microalbmin Nitrite Osmolality Osmolality ph Potassim Protein Protein-to-creatinine ratio Red Blood Cells Sodim Specific Gravity Urobilinogen White Blood Cells ph Potassim Protein Red Blood Cells Sodim Specific Gravity Urobilinogen White Blood Cells Dropper Tips - Pkg MAS P/N

11 Sentry Urine Dipstick Control Ideal for se otside the clinical laboratory where refrigerated storage isn t always available. The Sentry Urine Dipstick Control offers 12 months room temperatre stability for an immediate, ready to se rinalysis strip control. Sitable for Mtistix, Chemstrips, Diascreen and other rinalysis strips as well as atomated strip readers. Spplied in two levels, normal and abnormal. Part Nmber URN5005 Level Bottles & Size Storage & Stability Matrix Bi-level, Mlti-Pack 4 x 25 ml 18 months shelf life 2 to 8 ºC 12 months room temperatre Synthetic Bilirbin Blood Glcose Hman Chorionic Gonadotropin (hcg) Lekocytes Ketones Microalbmin Nitrite ph Protein Specific Gravity Urobilinogen MAS UrichemTRAK UrichemTRAK is designed to qantitatively monitor the most commonly tested rine chemistry analytes. This liqid, assayed control is ready-to-se, reqires no additional preparation and the non-azide formlation will not interfere with ISEs. It incldes general chemistry, physical properties and hcg tests. Part Nmber Level Bottles & Size Storage & Stability Matrix UR UR month shelf 2 to 8 ºC Hman 6 x 15 ml Bi-level, opened and nopened Urine UR-MP Mlti-Pack Amylase Calcim Chloride Cortisol Creatinine Glcose Hman Chorionic Gonadotropin (hcg) Magnesim Microalbmin Osmolality ph Phosphors Potassim Sodim Specific Gravity Total Protein Urea Nitrogen Uric Acid Refer to package insert for specific analyte, stability claims, and limitations of procedres. Shelf life starts from the date of manfactre. Availability of prodcts in each contry depends on local reglatory marketing athorization stats. Dropper Tips - Pkg MAS P/N

12 Thermo Scientific MAS Immnoassay Controls MAS Liqimmne Save time and extra costs associated with lot changes sing the MAS Liqimmne controls now with an extended shelf life. This mlti-analyte immnoassay control is liqid based and designed to monitor immnoassay test procedres on atomated instrments. Provides coverage of fertility, thyroid, iron deficiency, endocrine and allergy parameters. Assayed vales are provided for major instrment systems. Part Nmber Level Bottles & Size Storage & Stability Matrix LIG month shelf -25 to -15 ºC LIG x 5 ml 90 days 2 to 8 ºC Hman Serm LIG days 2 to 8 ºC 17-a-OH-Progesterone Acetaminophen Aldosterone Alpha-Fetoprotein (AFP) Amikacin Carbamazepine Carcinoembryonic Antigen (CEA) CK-MB (activity) CK-MB (mass) Cortisol DHEA-Slfate Digoxin Disopyramide Estradiol Ethosximide Ferritin Folate Follicle Stimlating Hormone (FSH) Gentamicin Homocysteine Hman Chorionic Gonadotropin (beta-hcg) Hman Chorionic Gonadotropin (hcg) Hman Growth Hormone Immnogloblin A (IgA)* Immnogloblin E (IgE) Immnogloblin G (IgG)* Immnogloblin M (IgM)* Inslin Lidocaine Lithim Lteinizing Hormone (LH) N-acetylprocainamide (NAPA) Phenobarbital Phenytoin Primidone Procainamide Progesterone Prolactin Prostate Specific Antigen, Total (TPSA) Prostate Specific Antigen, Free (FPSA) Qinidine Salicylate Testosterone Theophylline Thyrogloblin Thyroid Stimlating Hormone (TSH) Thyroid Uptake (T-Uptake) Thyroxine, Free (FT4) Thyroxine, Total (TT4) Tobramycin Tricyclic Antidepressants Triiodthyronine, Free (FT3) Triiodthyronine, Total (TT3) Valproic Acid Vancomycin Vitamin B12 * These constitent levels have not been adjsted bt are at levels fond in the sorce material sed in preparation of the controls. No claim is made for expected vales of these constitents. Refer to package insert for specific analyte, stability claims, and limitations of procedres. Shelf life starts from the date of manfactre. Availability of prodcts in each contry depends on local reglatory marketing athorization stats. Dropper Tips - Pkg MAS P/N

13 MAS PTH Control PTH (Parathyroid Hormone) is commonly tested to assess Calcim reglation in blood. The MAS PTH Control offers three distinct PTH levels for evalation of atomated PTH methods across the assay range. Provided in a liqid format for ease of se, the MAS PTH Control offers 10 days open vial stability when stored at 2-8 ºC. Vale assignment is provided for the key atomated PTH methods available in today s clinical laboratory. Part Nmber PTH-MP Level Bottles & Size Storage & Stability Matrix Tri-level Mltipack 6 x 3 ml to 15 ºC 10 days 2 to 8 ºC Hman Serm Parathyroid Hormone (PTH) MAS PAR TDM This liqid therapetic drg control is a mlti-analyte control with assayed vales designed for therapetic drgs and common immnoassay test procedres on most atomated instrments. No additional preparation is reqired for this liqid, ready-to-se prodct that offers three significant levels. Part Level Bottles & Size Storage & Stability Matrix Nmber PTD month shelf 2 to 8 ºC Bovine PTD x 5 ml 30 days 2 to 8 ºC Serm PTD MAS T-Marker This liqid, assayed, mlti-analyte control is designed to monitor performance of varios cancer antigen tests on atomated instrments, sch as Abbott Architect, Beckman Access/Dxl, Ortho Vitros ECi, Roche Modlar Elecsys, Siemens Advia Centar and Immlite, and Tosoh AIA 600II. No additional preparation steps are reqired for these ready-to-se prodcts. Part Nmber TUM TUM TUM Level Bottles & Size Storage & Stability Matrix 6 x 3 ml 36 month shelf -25 to -15 ºC 90 days 2 to 8 ºC 30 days 2 to 8 ºC Hman Serm * Not cleared by FDA. These constitent levels have not been adjsted bt are at levels fond in the sorce material sed in preparation of the controls. No claim is made for expected vales of these constitents. Refer to package insert for specific analyte, stability claims, and limitations of procedres. Shelf life starts from the date of manfactre. Availability of prodcts in each contry depends on local reglatory marketing athorization stats. Dropper Tips - Pkg MAS P/N Acetaminophen Amikacin Caffeine Carbamazepine Digoxin Disopyramide Estriol Ethanol Ethosximide Gentamicin Lidocaine Lithim Methotrexate N-acetylprocainamide (NAPA) ACTH* Aldosterone Alpha-Fetoprotein (AFP) Beta Hman Chorionic Gonadotroopin (beta-hcg) Beta-2-Microgloblin CA 125 CA 15-3 CA 19-9 CA CA 72-4 Calcitonin Carcinoembryonic Antigen (CEA) Phenobarbital Phenytoin Primidone Procainamide Qinidine Salicylate Theophylline Thyroid Stimlating Hormone (TSH) Thyroxine, Total (TT4) Tobramycin Tricyclic Antidepressants Triiodthyronine, Total (TT3) Valproic Acid Vancomycin Cortisol CyFRA 21-1* Estradiol Ferritin Gastrin Hman Chorionic Gonadotroopin (hcg) Inslin NSE* Prolactin Prostate Specific Antigen, Total (TPSA) Prostate Specific Antigen, Free (FPSA) Prostatic Acid Phosphatase (PAP) Thyrogloblin 13

14 Thermo Scientific MAS Cardiac & Diabetes Controls MAS CardioImmne XL This mlti-analyte control is designed to monitor serm cardiac marker test methods. No additional preparation is reqired for this liqid, ready-to-se prodct. It offers for distinct levels, and is also available in a tri-level mltipack. Part Nmber Level Bottles & Size Storage & Stability Matrix CAI-XLL L 36 month shelf -25 to- 15 C CAI-XL days 2 to 8 C (for hscrp, CAI-XL2 2 Digitoxin, Troponin I and Homocysteine) 6 x 3 ml CAI-XL days 2 to 8 C Hman Serm CAI-XL4 Tri-level for BNP32, Myoglobin (when a dropper tip is Mlti-Pack sed), NT-proBNP, Troponin T, CK-MB BNP 32 CK-MB Digitoxin Homocysteine C-Reactive Protein high sensitivity (hs-crp) Myoglobin NT-pro BNP Troponin I Troponin T MAS CardioImmne Ultra Low A single analyte control designed to challenge the low end sensitivity of the next generation high sensitivity Troponin assays. Part Nmber Level Bottles & Size Storage & Stability Matrix CAI-UL UL 6 x 3 ml 36 month shelf -25 to -15 ºC 30 days 2 to 8 ºC Hman Serm MAS Diabetes This liqid assayed diabetes control is a bi-level control designed to monitor hemoglobin A1c methods. Assayed for most major instrment systems. The liqid, ready-to-se prodct reqires no additional preparation. Part Nmber Level Bottles & Size Storage & Stability Matrix 24 month shelf -25 to -15 ºC Bi-level Hman DBCL-MP 6 x 1 ml 60 days 2 to 8 C Mlti-Pack Whole Blood 30 days 2 to 8 ºC Troponin I Hemoglobin A1c (HbA1c) Refer to package insert for specific analyte, stability claims, and limitations of procedres. Shelf life starts from the date of manfactre. Availability of prodcts in each contry depends on local reglatory marketing athorization stats. Dropper Tips - Pkg MAS P/N

15 Immnology & Protein Controls MAS Immnology This mlti-analyte immnology liqid assayed control is designed to monitor the performance of varios serm protein and serology test procedres inclding Antistreptolysin O, C-Reactive Protein, Prealbmin and Rhematoid Factor. It is assayed for major instrment systems and is ready-to-se, reqiring no additional preparation. Three levels provide monitoring of the fll assay range. Part Nmber Level Bottles & Size Storage & Stability Matrix IC IC IC x 3 ml 24 month shelf 2 to 8 ºC 30 days 2 to 8 ºC Hman Serm Albmin Alpha-1-Antitrypsin Alpha-2-Macrogloblin Antistreptolysin O Antithrombin III Apha-1-Acid-Glycoprotein Apolipoprotein A-1* Apolipoprotein B* Beta-2-Microgloblin C-Reactive Protein (CRP) C3 Complement C4 Complement Cerloplasmin Ferritin* Haptoglobin Immnogloblin A (IgA) Immnogloblin E (IgE) Immnogloblin G (IgG) Immnogloblin M (IgM) Kappa Light Chain Lambda Light Chain Prealbmin Properdin Factor B Rhematoid Factor (RF) Total Protein Transferrin MAS CSF This assayed, bi-level control is designed to monitor the performance of qantitative and manal chemical analysis of hman cerebrospinal flid. Mltiple oligoclonal bands are present in Level 2. Assayed for major instrment systems as well as for celllose acetate and agarose gel electrophoresis. These prodcts are liqid, ready-to-se and reqire no additional preparation. Part Nmber Level Bottles & Size Storage & Stability Matrix Bi-level, 24 month shelf 2 to 8 ºC CSF-MP 6 x 3.5 ml Hman Serm Mlti-Pack 30 days 2 to 8 ºC * These constitent levels have not been adjsted bt are at levels fond in the sorce material sed in preparation of the controls. No claim is made for expected vales of these constitents. Refer to package insert for specific analyte, stability claims, and limitations of procedres. Shelf life starts from the date of manfactre. Availability of prodcts in each contry depends on local reglatory marketing athorization stats. Albmin Alpha-1-Globlin Alpha-2-Globlin Beta-Globlin Chloride Gamma-Globlin Glcose Gltamine Immnogloblin A (IgA)* Immnogloblin G (IgG)* Immnogloblin M (IgM)* Lactate Dehydrogenase (LDH) Lactic Acid Oligoclonal Bands Potassim Prealbmin Sodim Total Protein Dropper Tips - Pkg MAS P/N

16 Thermo Scientific MAS Toxicology Controls MAS DOA TOTAL This mlti-constitent rine toxicology control offers 19 analytes with 4 distinct levels at drg concentrations 25% below and above commonly sed screening and SAMHSA* ctoffs. A drg-free level and high positive level are also available (6 levels total). The control is a liqid, ready-to-se prodct available for se on a variety of instrment platforms. Each level of control is individally packed which gives yo the flexibility to choose yor levels according to yor drg screen panel ctoffs while keeping the nmber of control vials to a minimm. Part Nmber Level Bottles & Size Storage & Stability Matrix DOAT-1 1 DOAT-2 2 DOAT x 18 ml DOAT month shelf 2 to 8 ºC Hman Urine DOAT days open 2 to 8 ºC DOAT-6 6 DOAT-MP Mlti Pack 1 bottle per level, 18 ml each 11-nor-9-COOH-D9-THC Benzoylecgonine Bprenorphine Cotinine d-methamphetamine EDDP Ethanol Ethyl Glcronide LSD Methadone Methaqalone Morphine, free Nitrazepam Nortriptyline Oxazepam Oxycodone Phencyclidine Propoxyphene Secobarbital MAS TOX Control This mlti-analyte control is developed for se with the Thermo Scientific MAS Toxicology immnoassays for the semiqantitative measrement of barbitrates, benzodiazepine, and tricyclic antidepressants in either serm or plasma. Part Nmber Level Bottles & Size Storage & Stability Matrix Mlti-Pack 3 levels 6 x 5 ml 24 months shelf 2 to 8 ºC 20 days open 2 to 8 ºC Bovine Plasma Barbitrate (Secobarbital) Benzodiazepine (Diazepam) Tricyclic Antidepressants (Nortriptyline) (for se with DRI Serm Tox Reagents) * Sbstance Abse and Mental Health Services Administration (SAMHSA) Refer to package insert for specific analyte, stability claims, and limitations of procedres. Shelf life starts from the date of manfactre. Availability of prodcts in each contry depends on local reglatory marketing athorization stats. Dropper Tips - Pkg MAS P/N

17 Qality Control Soltions for Vista Designed for se with the Siemens Dimension Vista instrmentation Thermo Scientific MAS qality control prodcts are available in vials specifically designed for se with the Siemens Dimension Vista instrmentation. Flly validated onboard QC stability claims provide assrance that longterm qality assrance is maintained when performing rotine qality control on the Dimension Vista instrment. Nine individal Thermo Scientific MAS qality control prodcts are available in a Dimension Vista specific format covering the instrment assay portfolio. Six vials are provided in each kit for convenience. MAS Alcohol/Ammonia Part Nmber Level Bottles & Size Storage & Stability Matrix Bi-level, 24 month shelf 2 to 8 ºC x 2 ml Hman Serm Mlti-Pack 7 days onboard instrment Ammonia Ethanol MAS CardioImmne XL Part Nmber Level Bottles & Size Storage & Stability Matrix L month shelf -25 to -15 ºC 6 x 2 ml days onboard instrment Hman Serm Refer to package insert for specific analyte, stability claims, and limitations of procedres. Shelf life starts from the date of manfactre. Availability of prodcts in each contry depends on local reglatory marketing athorization stats. C-Reactive Protein high sensitivity (hscrp) CK-MB Digitoxin Homocysteine Myoglobin NT-pro BNP Troponin I 17

18 Thermo Scientific MAS Qality Control Soltions for Vista MAS chemtrak H Part Nmber Level Bottles & Size Storage & Stability Matrix x 2 ml 30 month shelf -25 to -15 ºC Hman Serm Assayed 7 days onboard instrment Acetaminophen Alanine Aminotransferase (ALT) Albmin Alkaline Phosphatase Amylase Apolipoprotein A Apolipoprotein B Aspartate Aminotransferase (AST) Bilirbin Direct (DBIL) Bilirbin Total (TBIL) Blood Urea Nitrogen (BUN) C3 Complement* C4 Complement* Calcim Carbamazepine Carbon Dioxide (CO2) Chloride Cholesterol Creatine Kinase (CK) Creatinine Digoxin Ethanol Ferritin* Gamma-Gltamyl Transferase (GGT) Gentamicin Glcose Haptoglobin HDL Cholesterol Immnogloblin A (IgA)* Immnogloblin G (IgG)* Immnogloblin M (IgM)* Iron Iron Binding Capacity, Total (TIBC) Lactate Dehydrogenase (LDH) Lactic Acid LDL Cholesterol Lidocaine Lipase Lithim Magnesim N-acetylprocainamide (NAPA) Phenobarbital Phenytoin Phosphors Potassim Prealbmin Procainamide Psedocholinesterase Salicylate Sodim Theophylline Thyroid Stimlating Hormone (TSH) Thyroid Uptake (T-Uptake) Thyroxine, Free (FT4)* Thyroxine, Total (TT4) Tobramycin Total Protein Transferrin* Tricyclic Antidepressants Triglycerides Triiodthyronine, Free (FT3)* Triiodthyronine, Total (TT3)* Uric Acid Valproic Acid Vancomycin MAS CSF Part Nmber Level Bottles & Size Storage & Stability Matrix Bi-level, 24 month shelf 2 to 8 ºC x 2 ml Hman Serm Mlti-Pack 7 days onboard instrment * These constitent levels have not been adjsted bt are at levels fond in the sorce material sed in preparation of the controls. No claim is made for expected vales of these constitents. Albmin Chloride Glcose Immnogloblin A (IgA)* Immnogloblin G (IgG)* Immnogloblin M (IgM)* Lactate Dehydrogenase (LDH) Lactic Acid Potassim Prealbmin Sodim Total Protein Refer to package insert for specific analyte, stability claims, and limitations of procedres. Shelf life starts from the date of manfactre. Availability of prodcts in each contry depends on local reglatory marketing athorization stats. 18

19 MAS Diabetes Part Nmber Level Bottles & Size Storage & Stability Matrix Bi-level 24 month shelf -25 to -15 ºC Hman Whole DBCL-V 6 x 2 ml Mlti-Pack 7 days onboard instrment Blood Hemoglobin A1c (HbA1c) MAS Immnology Part Nmber Level Bottles & Size Storage & Stability Matrix IC-V month shelf 2 to 8 ºC IC-V2 2 6 x 2 ml Hman Serm 7 days onboard instrment IC-V3 3 Albmin Alpha-1-Acid-Glycoprotein Alpha-1-Antitrypsin Alpha-2-Macrogloblin Antistreptolysin O (ASO) Apolipoprotein A1* Apolipoprotein B* Beta-2-Microgloblin C-Reactive Protein (CRP) C3 Complement C4 Complement Cerloplasmin Ferritin* Haptoglobin Immnogloblin A (IgA) Immnogloblin E (IgE) Immnogloblin G (IgG) Immnogloblin M (IgM) Kappa Light Chain Lambda Light Chain Prealbmin Rhematoid Factor (RF) Total Protein Transferrin MAS Liqimmne Part Nmber Level Bottles & Size Storage & Stability Matrix month shelf -25 to -15 ºC x 2 ml Hman Serm 7 days onboard instrment Acetaminophen Alpha-Fetoprotein (AFP) Carbamazepine Carcinoembryonic Antigen (CEA) CK-MB (activity) CK-MB (mass) Digoxin Estradiol Ferritin Folate Folate Stimlating Hormone (FSH) Gentamicin Homocysteine Hman Chorionic Gonadotropin (beta-hcg) Immnogloblin A (IgA) Immnogloblin E (IgE) Immnogloblin G (IgG) Immnogloblin M (IgM) Lidocaine Lithim Ltenizing Hormone (LH) N-acetylprocainamide (NAPA) Phenobarbital Phenytoin Procainamide Prolactin Prostate Specific Antigen (PSA) Prostate Specific Antigen Free (FPSA) Salicylate Testosterone Theophylline Thyroid Stimlating Hormone (TSH) Thyroid Uptake (T-Uptake) Thyroxine, Free (FT4) Thyroxine, Total (TT4) Tobramycin Tricyclic Antidepressants Triiodthyronine, Free (FT3) Triiodthyronine, Total (TT3) Valproic Acid Vancomycin Vitamin B12 MAS UrichemTRAK Part Nmber Level Bottles & Size Storage & Stability Matrix Bi-level, 24 month shelf 2 to 8 ºC x 2 ml Hman Urine Mlti-Pack 7 days onboard instrment Amylase Calcim Chloride Cortisol Creatinine Glcose Magnesim Microalbmin Phosphors Potassim Sodim Total Protein Urea Nitrogen Uric Acid * These constitent levels have not been adjsted bt are at levels fond in the sorce material sed in preparation of the controls. No claim is made for expected vales of these constitents. Refer to package insert for specific analyte, stability claims, and limitations of procedres. Shelf life starts from the date of manfactre. Availability of prodcts in each contry depends on local reglatory marketing athorization stats. 19

20 Thermo Scientific LabLink xl Qality Assrance Software Abot LabLink xl Monitor yor internal qality control while comparing reslts with other labs arond the globe in real-time with Thermo Scientific LabLink xl clod-based qality assrance software. Trly Real-Time Peer Comparison Software Peer data is pdated instantly Daily QC Integration for MAS and Other QC Prodcts All yor QC prodcts are in one place Simple and Intitive Interface Interactive Levey-Jennings charts, Westgard rles, and adit-friendly reports Atomated QC Data Transfer With select systems Clod-Based SSL encrypted. Atomatically receive ftre pdates No Sbmission Ctoff Dates Review data whenever yo want Sigma Score and Other Performance Metrics %Bias, SDI, CVI, Z score, and more Mltiple Lab Management Scalable software grows with yor organization Validated Software FDA and GAMP 5 compliance Mltilingal Capabilities Available in 15+ langages 20

21 Trobleshoot faster with real-time peer comparison Compare yor data with labs arond the globe or jst yor affiliated network. Determine if a worrisome reslt is an instrment problem, widespread isse, or acceptable vale. Peer data is pdated in real-time, so yo can identify trends and shifts sooner. Day-to-day QC all in one place Levey-Jennings Charts Westgard Sigma Rles Perform all yor daily QC activities inside LabLink xl with interactive charts and graphs. Compare Levey-Jennings charts for mltiple instrments. Select Westgard and RiliBÄK violation rles. Flag and comment on individal data points. Use with MAS prodcts or any other QC manfactrer* * Non-MAS prodcts are spported by or atoconnectivity and Daily QC featres sch as report generation, Levey-Jennings charts, Westgard rles, mltiple lab management, and affiliated lab comparison. Peer Data for non-mas Prodcts is not available at this time. 21

22 Thermo Scientific LabLink xl Qality Assrance Software Adit-friendly reports Visalize data the way yo want Easy-to-read reports help yo monitor individal lab performance by shift, day and month View peer data alongside yor laboratory data Internal Performance Peer Data Comparison Adit History Region Specific Comparison Affiliated Lab Adit Rilibak Data Smmary Levey-Jennings QC Smmary Condensed Interlab Drgs of Abse Individal Lab Point Data Sbmission Smmary Data Sbmission Rilibak NEW IN LABLINK XL 2.0 Errors and Exceptions Instrment Interlab Affliliated Exception Notes Method Performance Exception Notes Monthly Smmary Statistical Smmary Smmary Urinalysis Yoden Signatre Verification and Delivery Review and digitally sign reports (athorized sers only) Schedle reports to be atomatically delivered to yor inbox every month 22

23 Poplar reports Method Performance and Sigma Score See which instrments are performing the best for a particlar method and test. Levey-Jennings Report Displays individal daily QC reslts or the daily mean for a selected date range on a Levey-Jennings chart. Choose between CLIA qality goals or cstom goals for total allowable error. View Levey-Jennings charts for a single level or mltiple levels at the same time for qick comparison. Individal Lab Report Test-by-test listing of yor lab s statistics and yor peer grop s statistics for a given month. Statistical Smmary Report Displays a statistical analysis for each of yor lab s tests alongside yor peer grop s reslts for a given month. Total Error Graph compares yor lab s method to yor peer grop s mean and yor chosen total allowable error limits. View performance metrics sch as Mean, SD, CV, SDI, CVI and % Bias all on one screen. Monthly Smmary Report Shows a histogram of yor lab s data alongside yor peer grop s data. Qickly identify shifts and trends with a month-bymonth snapshot of yor lab s performance. Exception Notes Report Smmarizes which QC reslts and corresponding analytical methods fell otside the performance criteria in a given month. Designated vales are flagged as otliers with respect to the lab s mean, peer grop mean, total allowable error, or other limits for each test. 23

24 Thermo Scientific LabLink xl Qality Assrance Software Performance metrics inclding Sigma Score %Bias Percent difference between yor observed test reslts and yor lab s target mean. Coefficient of Variation (CVI) Compares yor lab s CV to yor target CV to evalate precision with respect to yor chosen target. Standard Deviation Index (SDI) Compares yor lab s mean to yor target mean to evalate accracy with respect to yor chosen target. Sigma Indicates how mch yor data varies from the total allowable error limit by calclating the nmber of standard deviations in a given test system that fit within yor chosen qality goals. Z Score Measres how many standard deviations away an individal QC reslt is from the target mean. 24

25 Mltiple lab management scalable software grows with yor organization View data from a specific lab, or all yor labs combined. Compare reslts within yor affiliated network. Permissions hierarchy with mltiple levels of ser access - Elite User: For administrators who need fll access to data across all labs. - Intermediate User: For Lab managers who need to review data and sign reports. - Basic User: For technologists who need to sbmit data. Visalize yor reslts in real time Levey-Jennings Instrment Comparison Global Peer Review 25

26 Thermo Scientific LabLink xl Qality Assrance Software Stay p-to-date with Resorce Center View the latest package inserts, spplements, MSDS, and Certificates of Analysis for MAS prodcts Receive prodct pdates and important notifications via Download additional docments sch as User Gide and QC handling gidelines 26

27 Freqently Asked Qestions Q: Is LabLink xl secre? A: Absoltely. LabLink xl ses SSL encryption to ensre yor data is protected. Q: Can I create niqe login credentials for each ser? A: Yes. Each ser can have a niqe login ID and password, and the lab administrator can set different levels of permission for each ser. For example, an administrative ser can sign reports while a lab technician can only view and enter data. Q: I have non-mas prodcts. Do I need to se other software? A: Non-MAS prodcts are spported by ato-connectivity and Daily QC featres sch as report generation, Levey-Jennings charts, Westgard rles, mltiple lab management, and affiliated lab review. Peer data for non-mas prodcts is not available at this time. Q: Does LabLink xl offer both manal and atomated data entry options? A: Yes. LabLink xl offers options for atomated data entry as well as manal data entry (individal points or smmary data). Q: Does LabLink xl have access to my patient data? A: No. Even with or atomated connectivity options, patient data never leaves yor lab, and is never seen by LabLink xl. Interested in learning more? Or specialists can provide a software demonstration, go over atoconnectivity options, and more. Visit maslablink.com or s at lablink.qap@thermofisher.com 27

28 Thermo Scientific MAS QC Vale Assignment Program Testing Gidelines Each new lot of QC will tilize a different grop of vale assignment partner laboratories as participants are not reqired to test every QC lot. Advance notification of when to expect samples will be sent ot prior to testing. Instrctions for testing and data entry forms are sent with all vale assignment samples. Most tests are rn in dplicate over three separate days. All testing mst to be completed within 4-6 weeks of receiving the samples. Vale assignment is an important reqirement when rolling over to a new lot of QC material. The ability to provide fll coverage of instrment target vales involves the partnership of Thermo Fisher Scientific with laboratories performing the reqired testing. Withot involvement of these external laboratories, the ability to provide vale assignment coverage is significantly redced. Thermo Fisher Scientific is actively looking for new laboratories that are willing to assist with MAS QC Vale Assignment in retrn for monetary compensation or free QC prodcts. The reslts received from the participating laboratories are sed to establish QC ranges in the lot specific package inserts for the MAS Qality Controls. Compensation Options Monetary: This is typically based pon a flat fee per data point pls reagent costs. As this varies between test systems and methods, there is no standard amont. The different reimbrsement options will be discssed prior to prodct shipment. Free of charge MAS QC prodct: This is based pon the nmber of tests and MAS prodcts being vale assigned. Free QC prodct is given at the discretion of yor sales representative. Frther details will be provided by a member of the vale assignment team. Participation Reqirements CLIA certification or eqivalent local accreditation. A completed W-9 form (US only). A completed srvey noting instrments and testing capabilities. Steps to follow if yo are interested in participating in the MAS Vale Assignment Program Step 1: Complete the form below. Step 2: Fax this page to or to MGC-VA@thermofisher.com. Step 3: A vale assignment introdction pack will be sent via mail or . Please complete the forms and retrn to s. Step 4: Once the introdction pack is received, a member of the vale assignment team will notify yo to discss acceptance into the program and the different methods of compensation. Lab Name: Lab Address: Contact Name: Alternate Contact: Phone Nmber: Fax Nmber: Accreditation #: Fax to: to: MGC-VA@thermofisher.com 28

29 Reference and Ordering Instrments Order Placement Technical Service & Spport

30 References Page Analyte Alcohol/Ammonia Bilirbin CardioImmne XL chemtrak H CSF Diabetes DOA TOTAL Immnology Liqimmne Omni CARDIO Omni CORE Omni Immne Omni Immne PRO PAR TDM PTH Control Sentry Urine Dipstick Control TOX Control T-Marker UA Control UA Dip Tbe Urinalysis UrichemTRAK Vista Alcohol/Ammonia Vista CardioImmne XL Vista chemtrak H Vista CSF Vista Diabetes Vista Immnology Vista Liqimmne Vista UrichemTRAK 17-OH-Progesterone 25-OH-Vitamin D Acetaminophen Acid Phosphatase Adrenocorticotropic Hormone Albmin (BCG) Albmin (BCP) Aldosterone Alkaline Phosphatase (ALP) alpha-1- Acid Glycoprotein alpha-1-antitrypsin alpha-2-macrogloblin alpha-fetoprotein (AFP) Aldosterone Alanine Aminotransferase (ALT) Amikacin Amitriptyline Ammonia Amphetamines Amylase Amylase (Pancreatic) Antistreptolysin O (ASO) Anti-Thyrogloblin (anti-tg) Anti-Thryroid Peroxidase (anti-tpo) Antithrombin III Apolipoprotein A1 Apolipoprotein B Appearance Aspartate Amonitransferase (AST) Barbitrates Benzodiazepines beta-2-microgloblin Hman Chorionic Gonadotropin (beta-hcg) Bile Acids Bilirbin, Conjgated Bilirbin, Direct Bilirbin, Neonatal Bilirbin, Total Bilirbin, Unconjgated Bilirbin, Urine BNP 32 Blood Urea Nitrogen (BUN) Bprenorphine C-Peptide C-Reactive Protein (CRP) C3 Complement C4 Complement CA Analyte present. - No claim is made for expected vales or the stability of these constitents. 30

31 Page Analyte Alcohol/Ammonia Bilirbin CardioImmne XL chemtrak H CSF Diabetes DOA TOTAL Immnology Liqimmne Omni CARDIO Omni CORE Omni Immne Omni Immne PRO PAR TDM PTH Control Sentry Urine Dipstick Control TOX Control T-Marker UA Control UA Dip Tbe Urinalysis UrichemTRAK Vista Alcohol/Ammonia Vista CardioImmne XL Vista chemtrak H Vista CSF Vista Diabetes Vista Immnology Vista Liqimmne Vista UrichemTRAK CA 19-9 CA CA 72-4 CA 125 Caffeine Calcitonin Calcim Cannabinoids (THC) Carbamazepine Carbamazepine (Free) CEA (carcinoembryonic antigen) Cerloplasmin Chloramphenicol Chloride Cholesterol Creatine Kinase (CK) CK-MB Carbon Dioxide (CO2) Cocaine (Benzoylecgonine) Color Cortisol Cotinine Copper Creatinine Crystals CYFRA 21-1 d-dimer d-methamphetamine Diazepam DHEA-Slfate Digitoxin Digoxin Disopyramide EDDP (Methadone Metabolite) Estradiol Estriol Estriol (Free) - Analyte present. - No claim is made for expected vales or the stability of these constitents. 31

32 References Page Analyte Alcohol/Ammonia Bilirbin CardioImmne XL chemtrak H CSF Diabetes DOA TOTAL Immnology Liqimmne Omni CARDIO Omni CORE Omni Immne Omni Immne PRO PAR TDM PTH Control Sentry Urine Dipstick Control TOX Control T-Marker UA Control UA Dip Tbe Urinalysis UrichemTRAK Vista Alcohol/Ammonia Vista CardioImmne XL Vista chemtrak H Vista CSF Vista Diabetes Vista Immnology Vista Liqimmne Vista UrichemTRAK Ethanol Ethanol Ethyl Glcronide (EtG) Ferritin Folate (Vitamin B9) Frctosamine FSH (folicle stimlating hormone) Gastrin Gentamicin Gamma-Gltamyl Transferase (GGT) Globlins Glcose Haptoglobin Hman Chorionic Gonadotropin (hcg) HDL Cholesterol Hemoglobin (Urine Test) Hemoglobin A1c (HbA1c) Homocysteine hsc-reactive Protein (hscrp) Hman Growth Hormone Imipramine Immnogloblin A (IgA) Immnogloblin E (IgE) Immnogloblin G (IgG) Immnogloblin M (IgM) Inhibin A Inslin IGF-1 (inslin-like growth factor 1) Iron Iron Binding Capacity (IBC) Kappa Light Chain Ketones Lactic Acid Lambda Light Chain Lactate Dehydrogenase (LDH) LDL Cholesterol Lekocyte Esterase Lidocaine Lipase Lipoprotein (a) Lithim LSD Lteinizing Hormone (LH) Magnesim Methadone Methaqalone Methotrexate - Analyte present. - No claim is made for expected vales or the stability of these constitents. 32

33 Page Analyte Alcohol/Ammonia Bilirbin CardioImmne XL chemtrak H CSF Diabetes DOA TOTAL Immnology Liqimmne Omni CARDIO Omni CORE Omni Immne Omni Immne PRO PAR TDM PTH Control Sentry Urine Dipstick Control TOX Control T-Marker UA Control UA Dip Tbe Urinalysis UrichemTRAK Vista Alcohol/Ammonia Vista CardioImmne XL Vista chemtrak H Vista CSF Vista Diabetes Vista Immnology Vista Liqimmne Vista UrichemTRAK Microalbmin Morphine, Free Myoglobin Myeloperoxidase (MPO) N-acetylprocainamide (NAPA) N-Terminal Brain Natriretic Peptide (NT-proBNP) Nitrite Nordiazepam Nortriptyline NSE Oligoclonal Bands Opiates (Morphine, Free) Osmolality Oxazepam Oxycodone Prostatic Acid Phosphatase (PAP) Parathyroid Hormone (PTH) ph Phencyclidine (PCP) Phenobarbital Phenytoin Phenytoin (Free) Phosphors Potassim Prealbmin Pregency Associated Plasma Protein (PAPP-A) Primidone NT-proBNP Procalcitonin (PCT) Procainamide Progesterone Prolactin Properdin Factor B Propoxyphene Protein Electrophoresis Prostate Specific Antigen, Total (TPSA) - Analyte present. - No claim is made for expected vales or the stability of these constitents. 33

34 References Page Analyte Alcohol/Ammonia Bilirbin CardioImmne XL chemtrak H CSF Diabetes DOA TOTAL Immnology Liqimmne Omni CARDIO Omni CORE Omni Immne Omni Immne PRO PAR TDM PTH Control Sentry Urine Dipstick Control TOX Control T-Marker UA Control UA Dip Tbe Urinalysis UrichemTRAK Vista Alcohol/Ammonia Vista CardioImmne XL Vista chemtrak H Vista CSF Vista Diabetes Vista Immnology Vista Liqimmne Vista UrichemTRAK Prostate Specific Antigen, Free (FPSA) Psedocholinesterase (PCHE) Qinidine Red Cells (Urine Test) Rhematoid Factor (RF) Salicylate Secobarbital Sex Hormone Binding Globlin (SHBG) Sodim Specific Gravity Testosterone Thyroid Uptake (T-Uptake) Triiodothyroxine, Total (TT3) Triiodothyroxine, Free (FT3) Thyroxine, Total (TT4) Thyroxine, Free (FT4) TBG (Thyroxine-Binding Globlin) Theophylline Thyrogloblin Iron Binding Capacity, Total (TIBC) Tobramycin Total Protein Transferrin Tricyclic Antidepressants Triglycerides Troponin I Troponin T Thyroid Stimlating Hormone (TSH) Iron Binding Capacity, Unsatrated (UIBC) Urea Nitrogen Uric Acid Urobilinogen Valproic Acid Valproic Acid Free Vancomycin Vitamin B12 White Cells (Urine Test) Zinc - Analyte present. - No claim is made for expected vales or the stability of these constitents. 34

35 Page Instrment Alcohol/Ammonia Bilirbin CardioImmne XL chemtrak H CSF Diabetes DOA TOTAL Immnology Liqimmne Omni CARDIO Omni CORE Omni Immne Omni Immne PRO PAR TDM PTH Control Sentry Urine Dipstick Control TOX Control T-Marker UA Control UA Dip Tbe Urinalysis UrichemTRAK Vista Alcohol/Ammonia Vista CardioImmne XL Vista chemtrak H Vista CSF Vista Diabetes Vista Immnology Vista Liqimmne Vista UrichemTRAK ABBOTT Architect ACON INTERNATIONAL ACON Mission (Visal) Mission U120 Mission U500 BECKMAN-COULTER Access AU Series ICON ICON/11/25/20 Immage Synchron CX/LX UniCel DxI UniCel DxC Synchron BIOLIS 24i Clinical Systems BIOMERIEUX Vidas Systems BIOVATION Biovation BIORAD DiaSTAT D-10 Variant/Variant II COLE TAYLOR MARKETING, INC. (VISUAL) Cole Taylor (on CT-120) Cole Taylor (on Clinitek) DFI DIAGNOSTICS DFI ComboStik (Visal) DFI ComboStik Series DFI ComboStik CYBOW (Visal) DFI ComboStick CYBOW Series DFI 10 +/ DUS (Visal) DFI DU Reader 300 DFI DUS R-300 ERBA DIAGNOSTICS ERBA Urodip (Visal) ERBA Urodipcheck Analyte present. - No claim is made for expected vales or the stability of these constitents. 35