HUMAN ASSAYED MULTI-SERA - LEVEL 2 (HUM ASY CONTROL 2)

Transcription

1 0120 HUMAN ASSAYED MULTI-SERA - LEVEL 2 (HUM ASY CONTROL 2) CAT. NO. HN1530 / HS2611 LOT NO. 995UN SIZE: 20 x 5ml / 5 x 5ml EXP: INTENDED USE This product is intended for in vitro diagnostic use, in the quality control of diagnostic assays. The Human Assayed Multi-sera is for the control of accuracy. DEVICE DESCRIPTION The Human Assayed Multi-sera is supplied at 2 levels, level 2 and 3. Target values and ranges are supplied for the analytes listed in the values section at both levels. SAFETY PRECAUTIONS AND WARNINGS For in vitro diagnostic use only. Do not pipette by mouth. Exercise the normal precautions required for handling laboratory reagents. Human source material from which this product has been derived has been tested at donor level for the Human Immunodeficiency Virus (HIV 1, HIV 2) antibody, Hepatitis B Surface Antigen (HbsAg), and Hepatitis C Virus (HCV) antibody and found to be NON- REACTIVE. FDA approved methods have been used to conduct these tests. However, since no method can offer complete assurance as to the absence of infectious agents, this material and all patient samples should be handled as though capable of transmitting infectious diseases and disposed of accordingly. Health and Safety Data Sheets are available on request. STORAGE AND STABILITY OPENED: Store refrigerated (+2 C to +8 C). Reconstituted serum is stable for 8 hours at +15 C to +25 C or 7 days at +2 C to +8 C, and 28 days when frozen once at 18 C to 24 C. (See Limitations) UNOPENED: Store refrigerated (+2 C to +8 C). Stable to expiration date printed on individual vials. LIMITATIONS For Total & Prostatic Acid Phosphatase, the material should be stabilised by adding 1 drop (25-30µl) of 0.7M Acetic acid solution to 1ml of the serum exactly 30 minutes after reconstitution. After stabilisation Total and Prostatic Acid Phosphatase is stable for 2 hours at +15 C to +25 C, 2 days at +2 C to +8 C, and 28 days when frozen once at 18 C to 24 C. Alkaline Phosphatase levels in the reconstituted serum will rise over the stability period. It is recommended that the reconstituted serum be allowed to stand for 1 hour at +15 C to +25 C before measurement. Bilirubin in the serum is light sensitive and it is recommended that the serum be stored in the dark. Stored in the dark it is stable for 4 days at +2 C to +8 C. Do not store at +15 C to +25 C. Do not freeze. NEFA is stable for 1 day at +2 C to +8 C. Total PSA is stable for 4 days at +2 C to +8 C, or 28 days in aliquots frozen at 18 C to 24 C. Bacterial contamination of the reconstituted serum will cause reductions in the stability of many components. Different lot numbers of this control should not be interchanged, as the values assigned to the controls vary from lot to lot. The control should not be used as a calibration material. PREPARATION FOR USE The Human Assayed Multi-sera is supplied lyophilised. 1. Carefully reconstitute each vial of lyophilised serum with exactly 5ml of distilled water at +15 C to +25 C. Close the bottle and allow to stand for 30 minutes before use. Ensure contents are completely dissolved by swirling gently. Avoid formation of foam. Do not shake. 2. Refer to the Control section of the individual analyser application. 3. Refrigerate any unused material. Prior to reuse, mix contents thoroughly. MATERIALS PROVIDED Human Assayed Multi-sera - Level 2 20 x 5ml / 5 x 5ml T +44 (0) F +44 (0) E applications@randox.com I PAGE 1 OF 2

2 HN Lot No. 995UN 0120 MATERIALS REQUIRED BUT NOT PROVIDED Volumetric pipette ASSIGNED VALUES Each batch of assayed human serum is submitted to reference laboratories for assignment against international Reference Standards. Where international Reference Standards are unavailable, Reference Methods are used. Values are also collected from approx laboratories worldwide and using a unique statistical analysis, a value is assigned. With each batch, a control range is provided for individual parameters and each parameter method. The control range is equivalent to the assigned mean ±2S.D. This results in an assayed serum with extremely accurate values, which may be confidently used by laboratories to ensure the accuracy of their methods. If an instrument specific value is not available, refer to the Mean of all Instruments section. If necessary, contact Randox Laboratories - Technical Services, Northern Ireland, tel: +44 (0) or Technical.Services@randox.com NOTES All trademarks recognised (1) Applies only in Germany. Ranges established according to the Guidelines of the Federal Chamber of Physicians in Germany. (2) Values established by reference laboratories officially recognised by the Federal Chamber of Physicians in Germany. (3) DGKC: German Society for Clinical Chemistry. (4) IFCC: International Federation of Clinical Chemistry. (5) SCE: Scandinavian Committee on Enzymes. 30 Apr 15 ne T +44 (0) F +44 (0) E applications@randox.com I PAGE 2 OF 2

3 ABBOTT AEROSET ASSAYED HUMAN SERA LEVEL 2 (HUM ASY CONTROL 2) Albumin g/l Bromocresol Green g/dl ALT (GPT) U/l Tris buffer without P5P 37 C AST (GOT) U/l Tris buffer without P5P 37 C Bilirubin Direct µmol/l Diazo with Dichloroaniline (DCA) mg/dl Bilirubin Total µmol/l Diazo with Dichloroaniline (DCA) mg/dl µmol/l Diazo with Sulphanilic Acid mg/dl Calcium mmol/l Cresolphthalein complexone mg/dl mmol/l Arsenazo III mg/dl Cholesterol mmol/l Cholesterol Oxidase mg/dl Chloride mmol/l ISE direct CK Total U/l CK-NAC (IFCC) 37 C Creatinine µmol/l Alkaline picrate no deproteinization mg/dl Glucose mmol/l Hexokinase mg/dl Page 1 of 2 30/04/2015

4 ABBOTT AEROSET ASSAYED HUMAN SERA LEVEL 2 (HUM ASY CONTROL 2) Iron µmol/l Colorimetric without ppt. µg/dl LD (LDH) U/l L->P IFCC 37 C Phosphate Inorganic mmol/l Phosphomolybdate UV mg/dl Potassium mmol/l ISE method - direct Protein Total g/l Biuret reaction end point g/dl Sodium mmol/l ISE method - direct Triglycerides mmol/l Lipase/GPO-PAP no correction mg/dl Uric Acid (Urate) mmol/l Uricase peroxidase no ascorbate oxidase mg/dl mmol/l Uricase Peroxidase with ascorbate 546nm mg/dl Urea mmol/l Urease kinetic mg/dl mmol/l Urease hypochlorite mg/dl mmol/l BUN mg/dl Page 2 of 2 30/04/2015

5 Abbott Architect c/ci Systems ASSAYED HUMAN SERA LEVEL 2 (HUM ASY CONTROL 2) Albumin g/l Bromocresol Green g/dl g/l Bromocresol Purple g/dl Alkaline Phosphatase U/l AMP optimised to IFCC 37 C U/l AMP optimised to NVKC/SFBC 37 C U/l AMP non-optimised 37 C ALT (GPT) U/l Tris buffer without P5P 37 C Amylase Pancreatic U/I Immunoinhibition EPS substrate 37 C Amylase Total U/I Randox liquid stable pnpg7 37 C AST (GOT) U/l Tris buffer without P5P 37 C Bile Acids µmol/l Enzymatic Colorimetric Bicarbonate mmol/l Enzymatic Bilirubin Direct µmol/l Diazo with Sulphanilic Acid mg/dl µmol/l Diazo with Dichloroaniline (DCA) mg/dl Bilirubin Total µmol/l Diazo with Dichloroaniline (DCA) mg/dl µmol/l Diazo with Sulphanilic Acid mg/dl Page 1 of 5 30/04/2015

6 Abbott Architect c/ci Systems ASSAYED HUMAN SERA LEVEL 2 (HUM ASY CONTROL 2) Bilirubin Total µmol/l Dichlorophenyl Diazonium (DPD) mg/dl µmol/l Diazonium ion mg/dl Calcium mmol/l Arsenazo III mg/dl Cholesterol mmol/l Cholesterol Oxidase mg/dl Chloride mmol/l ISE indirect Cholinesterase U/l Colorimetric Butyrylthiocholine 37 C CK Total U/l CK-NAC serum start (DGKC) 37 C U/l CK-NAC (IFCC) 37 C Creatinine µmol/l Alkaline picrate no deproteinization mg/dl µmol/l Randox Enzymatic UV method mg/dl µmol/l Creatinine PAP method mg/dl µmol/l Jaffe rate blanked mg/dl µmol/l IDMS traceable mg/dl Free T4 pmol/l Abbott Architect ng/dl pg/ml Abbott Architect Page 2 of 5 30/04/2015

7 Abbott Architect c/ci Systems ASSAYED HUMAN SERA LEVEL 2 (HUM ASY CONTROL 2) gamma-gt U/I Gamma glutamyl.-3-carboxy-4-nitroanilide 37 C U/I Gamma Glutamyl-3-Carboxy-4-nitroanilide (IFCC) 37 C U/I DCL gamma glutamyl-3-carboxy-4-nitroanilide 37 C Glucose mmol/l Hexokinase mg/dl mmol/l Glucose oxidase mg/dl HDL - Cholesterol mmol/l Direct HDL PPD mg/dl mmol/l Direct Clearance Method mg/dl mmol/l HDL - Ultra mg/dl Iron µmol/l Colorimetric with ppt. µg/dl µmol/l Colorimetric without ppt. µg/dl Lactate mmol/l Colorimetric Lactate Oxidase mg/dl LD (LDH) U/l L->P 37 C U/l L->P IFCC 37 C Lipase U/I Other Colorimetric 37 C Lithium mmol/l Spectrophotometric mg/dl Magnesium mmol/l Arsenazo III mg/dl Page 3 of 5 30/04/2015

8 Abbott Architect c/ci Systems ASSAYED HUMAN SERA LEVEL 2 (HUM ASY CONTROL 2) Magnesium mmol/l Xylidyl Blue mg/dl mmol/l Methylthymol blue mg/dl mmol/l Enzymatic mg/dl Osmolality mosm/kg Calculated Phosphate Inorganic mmol/l Phosphomolybdate enzymatic mg/dl mmol/l Phosphomolybdate UV mg/dl Potassium mmol/l ISE method - indirect Protein Total g/l Biuret reaction end point g/dl g/l Biuret reaction kinetic g/dl PSA Total ng/ml = Abbott Architect Sodium mmol/l ISE method - indirect Thyroid Stimulating Hormone µu/ml = Abbott Architect TIBC µmol/l FE+UIBC(saturation with iron) µg/dl Total T3 nmol/l Abbott Architect ng/ml ng/dl Abbott Architect Page 4 of 5 30/04/2015

9 Abbott Architect c/ci Systems ASSAYED HUMAN SERA LEVEL 2 (HUM ASY CONTROL 2) Total T4 nmol/l Abbott Architect µg/dl ng/ml Abbott Architect Triglycerides mmol/l Lipase/GPO-PAP no correction mg/dl mmol/l Lipase/GPO-PAP 0.11mmol/l correction mg/dl mmol/l L/G Kinase EP. no correction mg/dl mmol/l Lipase/Glycerol Dehydrogenase mg/dl Uric Acid (Urate) mmol/l Uricase peroxidase with ascorbate oxidase mg/dl mmol/l Uricase peroxidase no ascorbate oxidase mg/dl mmol/l Uricase Peroxidase with ascorbate 546nm mg/dl Urea mmol/l Urease kinetic mg/dl mmol/l BUN mg/dl Page 5 of 5 30/04/2015

10 ABX Pentra 400 ASSAYED HUMAN SERA LEVEL 2 (HUM ASY CONTROL 2) Albumin g/l Bromocresol Green g/dl Alkaline Phosphatase U/l AMP optimised to IFCC 37 C ALT (GPT) U/l Tris buffer without P5P 37 C AST (GOT) U/l Tris buffer without P5P 37 C Calcium mmol/l Cresolphthalein complexone mg/dl Cholesterol mmol/l Cholesterol Oxidase mg/dl CK Total U/l CK-NAC (IFCC) 37 C gamma-gt U/I Gamma glutamyl.-3-carboxy-4-nitroanilide 37 C Iron µmol/l Colorimetric without ppt. µg/dl Magnesium mmol/l Xylidyl Blue mg/dl Phosphate Inorganic mmol/l Phosphomolybdate UV mg/dl Protein Total g/l Biuret reaction end point g/dl Uric Acid (Urate) mmol/l Uricase peroxidase with ascorbate oxidase mg/dl Page 1 of 1 30/04/2015

11 Beckman Coulter AU Series ASSAYED HUMAN SERA LEVEL 2 (HUM ASY CONTROL 2) Albumin g/l Bromocresol Green g/dl g/l Bromocresol Purple g/dl Alkaline Phosphatase U/l p-nitrophenylphosphate AMP 37 C U/l Roche Integra AMP buffer 37 C U/l AMP optimised to IFCC 37 C ALT (GPT) U/l Tris buffer without P5P 37 C Amylase Total U/I pnp Maltotrioside substrates 37 C U/I Biotrol - blocked pnpg7 37 C U/I Roche liquid stable pnpg7 37 C U/I Beckman Coulter - blocked pnpg7 37 C AST (GOT) U/l Tris buffer without P5P 37 C Bicarbonate mmol/l Enzymatic Bilirubin Direct µmol/l Dichlorophenyl Diazonium (DPD) mg/dl µmol/l Diazo with Dichloroaniline (DCA) mg/dl Bilirubin Total µmol/l Diazo with Sulphanilic Acid mg/dl µmol/l Dichlorophenyl Diazonium (DPD) mg/dl Page 1 of 5 30/04/2015

12 Beckman Coulter AU Series ASSAYED HUMAN SERA LEVEL 2 (HUM ASY CONTROL 2) Bilirubin Total µmol/l Diazonium ion mg/dl µmol/l Oxidation to Biliverdin mg/dl Calcium mmol/l Cresolphthalein complexone mg/dl mmol/l Arsenazo III mg/dl mmol/l NM-BAPTA mg/dl Cholesterol mmol/l Cholesterol Oxidase mg/dl Chloride mmol/l ISE indirect Cholinesterase U/l Colorimetric Butyrylthiocholine 37 C CK Total U/l CK-NAC substrate start (DGKC) 37 C U/l CK-NAC (IFCC) 37 C Copper µmol/l Colorimetric µg/dl Creatinine µmol/l Alkaline picrate no deproteinization mg/dl µmol/l Randox Enzymatic UV method mg/dl µmol/l Creatinine PAP method mg/dl Page 2 of 5 30/04/2015

13 Beckman Coulter AU Series ASSAYED HUMAN SERA LEVEL 2 (HUM ASY CONTROL 2) Creatinine µmol/l Roche Creatinine Plus mg/dl µmol/l Jaffe rate blanked mg/dl µmol/l Jaffe rate blanked comp. (-26 µmol/l) mg/dl µmol/l Jaffe rate blanked compensated (-18 µmol/l) mg/dl µmol/l IDMS traceable mg/dl D-3-Hydroxybutyrate mmol/l Tris buffer 100mmol ph 8.5 gamma-gt U/I Gamma glutamyl.-3-carboxy-4-nitroanilide 37 C U/I Gamma Glutamyl-3-Carboxy-4-nitroanilide (IFCC) 37 C GLDH U/I Triethanolamine buffer 50 mmol 37 C Glucose mmol/l Hexokinase mg/dl mmol/l Glucose oxidase mg/dl HDL - Cholesterol mmol/l Direct HDL Immunoseparation mg/dl mmol/l Direct Clearance Method mg/dl mmol/l Direct HDL Roche 3rd generation mg/dl Iron µmol/l Colorimetric with ppt. µg/dl Page 3 of 5 30/04/2015

14 Beckman Coulter AU Series ASSAYED HUMAN SERA LEVEL 2 (HUM ASY CONTROL 2) Iron µmol/l Colorimetric without ppt. µg/dl Lactate mmol/l Colorimetric Lactate Oxidase mg/dl LD (LDH) U/l L->P 37 C U/l P->L Scandinavian & Dutch 37 C U/l P->L German methods 37 C U/l L->P IFCC 37 C Lipase U/I Other Colorimetric 37 C U/I Roche Colorimetric 37 C U/I Randox Colorimetric 37 C Lithium mmol/l Spectrophotometric mg/dl Magnesium mmol/l Xylidyl Blue mg/dl Osmolality mosm/kg Calculated Phosphate Inorganic mmol/l Phosphomolybdate enzymatic mg/dl mmol/l Phosphomolybdate UV mg/dl Potassium mmol/l ISE method - indirect Protein Total g/l Biuret reaction end point g/dl Sodium mmol/l ISE method - indirect Page 4 of 5 30/04/2015

15 Beckman Coulter AU Series ASSAYED HUMAN SERA LEVEL 2 (HUM ASY CONTROL 2) TIBC µmol/l FE+UIBC(saturation with iron) µg/dl Triglycerides mmol/l Lipase/GPO-PAP no correction mg/dl mmol/l Lipase/GPO-PAP 0.11mmol/l correction mg/dl mmol/l L/G Kinase EP. no correction mg/dl Uric Acid (Urate) mmol/l Uricase peroxidase with ascorbate oxidase mg/dl mmol/l Uricase peroxidase no ascorbate oxidase mg/dl mmol/l Uricase Peroxidase with ascorbate 546nm mg/dl Urea mmol/l Urease end point mg/dl mmol/l Urease kinetic mg/dl mmol/l BUN mg/dl Page 5 of 5 30/04/2015

16 Beckman CX4/5/7/9/LX20 /DxC600/800 ASSAYED HUMAN SERA LEVEL 2 (HUM ASY CONTROL 2) Albumin g/l Bromocresol Purple g/dl Alkaline Phosphatase U/l p-nitrophenylphosphate AMP 37 C U/l AMP optimised to IFCC 37 C ALT (GPT) U/l Tris buffer without P5P 37 C U/l Tris buffer SCE 37 C Amylase Total U/I Beckman maltotetraose 37 C U/I Beckman Synchron AMY7 37 C AST (GOT) U/l Tris buffer without P5P 37 C U/l Tris buffer SCE 37 C Bicarbonate mmol/l Differential rate ph change mmol/l Ion selective electrode Bilirubin Direct µmol/l Diazo with Sulphanilic Acid mg/dl Bilirubin Total µmol/l Diazo with Sulphanilic Acid mg/dl µmol/l Dichlorophenyl Diazonium (DPD) mg/dl Calcium mmol/l Ion selective electrode mg/dl mmol/l Arsenazo III mg/dl Page 1 of 4 30/04/2015

17 Beckman CX4/5/7/9/LX20 /DxC600/800 ASSAYED HUMAN SERA LEVEL 2 (HUM ASY CONTROL 2) Cholesterol mmol/l Cholesterol Oxidase mg/dl Chloride mmol/l ISE indirect CK Total U/l CK-NAC (IFCC) 37 C U/l Monothioglycerol 37 C Creatinine µmol/l Alkaline picrate no deproteinization mg/dl µmol/l Randox Enzymatic UV method mg/dl µmol/l Jaffe rate blanked mg/dl µmol/l IDMS traceable mg/dl gamma-gt U/I Gamma glutamyl-4-nitroanilide 37 C Glucose mmol/l Hexokinase mg/dl mmol/l Glucose oxidase mg/dl HDL - Cholesterol mmol/l Direct HDL PPD mg/dl Iron µmol/l Colorimetric without ppt. µg/dl Lactate mmol/l Colorimetric Lactate Oxidase mg/dl Page 2 of 4 30/04/2015

18 Beckman CX4/5/7/9/LX20 /DxC600/800 ASSAYED HUMAN SERA LEVEL 2 (HUM ASY CONTROL 2) LD (LDH) U/l L->P 37 C U/l Pyruvate 1.4 mm - Beckman LD-P 37 C U/l L->P IFCC 37 C Lipase U/I Other Colorimetric 37 C Magnesium mmol/l Calmagite mg/dl Phosphate Inorganic mmol/l Phosphomolybdate UV mg/dl Potassium mmol/l ISE method - indirect Protein Total g/l Biuret reaction CX4/5/7 g/dl g/l Biuret reaction end point g/dl g/l Biuret reaction kinetic g/dl Sodium mmol/l ISE method - indirect Triglycerides mmol/l Lipase/GPO-PAP no correction mg/dl mmol/l L/G Kinase EP. no correction mg/dl Uric Acid (Urate) mmol/l Uricase peroxidase no ascorbate oxidase mg/dl Urea mmol/l Urease end point mg/dl mmol/l Urease kinetic mg/dl Page 3 of 4 30/04/2015

19 Beckman CX4/5/7/9/LX20 /DxC600/800 ASSAYED HUMAN SERA LEVEL 2 (HUM ASY CONTROL 2) Urea mmol/l BUN mg/dl Page 4 of 4 30/04/2015

20 BIOSYSTEMS A15 ASSAYED HUMAN SERA LEVEL 2 (HUM ASY CONTROL 2) Albumin g/l Bromocresol Green g/dl Alkaline Phosphatase U/l AMP optimised to IFCC 37 C U/I AMP optimised to IFCC 30 C U/I AMP optimised to IFCC 25 C Bilirubin Total µmol/l Diazo with Sulphanilic Acid mg/dl Cholesterol mmol/l Cholesterol Oxidase mg/dl Creatinine µmol/l Alkaline picrate no deproteinization mg/dl Glucose mmol/l Glucose oxidase mg/dl Protein Total g/l Biuret reaction end point g/dl Triglycerides mmol/l Lipase/GPO-PAP no correction mg/dl Uric Acid (Urate) mmol/l Uricase peroxidase with ascorbate oxidase mg/dl mmol/l Uricase peroxidase no ascorbate oxidase mg/dl Page 1 of 2 30/04/2015

21 BIOSYSTEMS A15 ASSAYED HUMAN SERA LEVEL 2 (HUM ASY CONTROL 2) Urea mmol/l Urease kinetic mg/dl mmol/l BUN mg/dl Page 2 of 2 30/04/2015

22 BIOSYSTEMS A25 ASSAYED HUMAN SERA LEVEL 2 (HUM ASY CONTROL 2) Albumin g/l Bromocresol Green g/dl Alkaline Phosphatase U/l AMP optimised to IFCC 37 C U/I AMP optimised to IFCC 30 C U/I AMP optimised to IFCC 25 C Bilirubin Total µmol/l Diazo with Sulphanilic Acid mg/dl Calcium mmol/l Arsenazo III mg/dl Cholesterol mmol/l Cholesterol Oxidase mg/dl CK Total U/l CK-NAC (IFCC) 37 C U/I CK-NAC (IFCC) 30 C U/I CK-NAC (IFCC) 25 C Creatinine µmol/l Alkaline picrate no deproteinization mg/dl Glucose mmol/l Glucose oxidase mg/dl HDL - Cholesterol mmol/l Direct Clearance Method mg/dl LD (LDH) U/l P->L Scandinavian & Dutch 37 C U/I P->L Scandinavian & Dutch 30 C U/I P->L Scandinavian & Dutch 25 C Page 1 of 2 30/04/2015

23 BIOSYSTEMS A25 ASSAYED HUMAN SERA LEVEL 2 (HUM ASY CONTROL 2) Protein Total g/l Biuret reaction end point g/dl Triglycerides mmol/l Lipase/GPO-PAP no correction mg/dl Uric Acid (Urate) mmol/l Uricase peroxidase with ascorbate oxidase mg/dl mmol/l Uricase peroxidase no ascorbate oxidase mg/dl Urea mmol/l Urease kinetic mg/dl mmol/l BUN mg/dl Page 2 of 2 30/04/2015

24 COBAS INTEGRA ASSAYED HUMAN SERA LEVEL 2 (HUM ASY CONTROL 2) Albumin g/l Bromocresol Green g/dl g/l Turbidimetric Assays g/dl Alkaline Phosphatase U/l Roche Integra AMP buffer 37 C U/I Roche Integra AMP buffer 30 C U/I Roche Integra AMP buffer 25 C ALT (GPT) U/l Tris buffer without P5P 37 C U/I Tris buffer without P5P 30 C U/I Tris buffer without P5P 25 C Amylase Pancreatic U/I Randox EPS Liquid and BM/Roche EPS Liquid 37 C Amylase Total U/I Roche Integra 2-chloro-pNPG7 37 C U/I Roche liquid stable pnpg7 37 C AST (GOT) U/l Tris buffer without P5P 37 C U/I Tris buffer without P5P 30 C U/I Tris buffer without P5P 25 C Bicarbonate mmol/l Enzymatic Bilirubin Direct µmol/l Dichlorophenyl Diazonium (DPD) mg/dl µmol/l Diazo with Sulphanilic Acid mg/dl Page 1 of 5 30/04/2015

25 COBAS INTEGRA ASSAYED HUMAN SERA LEVEL 2 (HUM ASY CONTROL 2) Bilirubin Total µmol/l Diazo with Dichloroaniline (DCA) mg/dl µmol/l Diazo with Sulphanilic Acid mg/dl µmol/l Dichlorophenyl Diazonium (DPD) mg/dl µmol/l Diazonium ion mg/dl Calcium mmol/l Cresolphthalein complexone mg/dl mmol/l NM-BAPTA mg/dl Cholesterol mmol/l Cholesterol Oxidase mg/dl Chloride mmol/l ISE indirect CK Total U/l CK-NAC substrate start (DGKC) 37 C U/I CK-NAC substrate start (DGKC) 30 C U/I CK-NAC substrate start (DGKC) 25 C U/l CK-NAC (IFCC) 37 C U/I CK-NAC (IFCC) 30 C U/I CK-NAC (IFCC) 25 C Creatinine µmol/l Alkaline picrate with deproteinization mg/dl µmol/l Alkaline picrate no deproteinization mg/dl Page 2 of 5 30/04/2015

26 COBAS INTEGRA ASSAYED HUMAN SERA LEVEL 2 (HUM ASY CONTROL 2) Creatinine µmol/l Creatinine PAP method mg/dl µmol/l Roche Creatinine Plus mg/dl µmol/l Jaffe rate blanked comp. (-26 µmol/l) mg/dl µmol/l Jaffe rate blanked compensated (-18 µmol/l) mg/dl gamma-gt U/I Gamma glutamyl.-3-carboxy-4-nitroanilide 37 C U/I Gamma glutamyl.-3-carboxy-4-nitroanilide 30 C U/I Gamma glutamyl.-3-carboxy-4-nitroanilide 25 C U/I Gamma Glutamyl-3-Carboxy-4-nitroanilide (IFCC) 37 C U/I Gamma Glutamyl-3-Carboxy-4-nitroanilide (IFCC) 30 C U/I Gamma Glutamyl-3-Carboxy-4-nitroanilide (IFCC) 25 C Glucose mmol/l Hexokinase mg/dl mmol/l Glucose oxidase mg/dl HDL - Cholesterol mmol/l Direct HDL PEGME mg/dl mmol/l Direct HDL Roche 3rd generation mg/dl Iron µmol/l Colorimetric with ppt. µg/dl µmol/l Colorimetric without ppt. µg/dl Page 3 of 5 30/04/2015

27 COBAS INTEGRA ASSAYED HUMAN SERA LEVEL 2 (HUM ASY CONTROL 2) Lactate mmol/l Colorimetric Lactate Oxidase mg/dl LD (LDH) U/l P->L German methods 37 C U/I P->L German methods 30 C U/I P->L German methods 25 C U/l L->P IFCC 37 C U/I L->P IFCC 30 C U/I L->P IFCC 25 C Lipase U/I Roche Colorimetric 37 C Lithium mmol/l Ion selective electrode mg/dl Magnesium mmol/l Xylidyl Blue mg/dl mmol/l Chlorphosphonazo III mg/dl Phosphate Inorganic mmol/l Phosphomolybdate enzymatic mg/dl mmol/l Phosphomolybdate UV mg/dl Potassium mmol/l ISE method - indirect Protein Total g/l Biuret reaction end point g/dl g/l Biuret reaction kinetic g/dl Page 4 of 5 30/04/2015

28 COBAS INTEGRA ASSAYED HUMAN SERA LEVEL 2 (HUM ASY CONTROL 2) Sodium mmol/l ISE method - indirect TIBC µmol/l FE+UIBC(saturation with iron) µg/dl Triglycerides mmol/l Lipase/GPO-PAP no correction mg/dl mmol/l Lipase/GPO-PAP 0.11mmol/l correction mg/dl mmol/l L/G Kinase EP. no correction mg/dl mmol/l Lipase/Glycerol Dehydrogenase mg/dl Uric Acid (Urate) mmol/l Uricase peroxidase with ascorbate oxidase mg/dl mmol/l Uricase peroxidase no ascorbate oxidase mg/dl mmol/l Uricase Peroxidase with ascorbate 546nm mg/dl Urea mmol/l Urease kinetic mg/dl mmol/l BUN mg/dl Page 5 of 5 30/04/2015

29 ELITech/Vitalab Selectra Pro/E/XL ASSAYED HUMAN SERA LEVEL 2 (HUM ASY CONTROL 2) Albumin g/l Bromocresol Green g/dl Alkaline Phosphatase U/l Diethanolamine buffer DEA 37 C ALT (GPT) U/l Tris buffer without P5P 37 C AST (GOT) U/l Tris buffer without P5P 37 C Bilirubin Total µmol/l Diazo with Sulphanilic Acid mg/dl Calcium mmol/l Cresolphthalein complexone mg/dl mmol/l Methylthymol blue mg/dl mmol/l Arsenazo III mg/dl Cholesterol mmol/l Cholesterol Oxidase mg/dl CK Total U/l CK-NAC (IFCC) 37 C Creatinine µmol/l Alkaline picrate no deproteinization mg/dl µmol/l Creatinine PAP method mg/dl µmol/l Jaffe rate blanked mg/dl Page 1 of 2 30/04/2015

30 ELITech/Vitalab Selectra Pro/E/XL ASSAYED HUMAN SERA LEVEL 2 (HUM ASY CONTROL 2) gamma-gt U/I Gamma Glutamyl-3-Carboxy-4-nitroanilide (IFCC) 37 C Glucose mmol/l Glucose oxidase mg/dl LD (LDH) U/l P->L German methods 37 C U/l L->P IFCC 37 C Phosphate Inorganic mmol/l Phosphomolybdate UV mg/dl Protein Total g/l Biuret reaction end point g/dl Triglycerides mmol/l Lipase/GPO-PAP no correction mg/dl Uric Acid (Urate) mmol/l Uricase Peroxidase with ascorbate 546nm mg/dl Urea mmol/l Urease kinetic mg/dl mmol/l BUN mg/dl Page 2 of 2 30/04/2015

31 HITACHI SERIES ASSAYED HUMAN SERA LEVEL 2 (HUM ASY CONTROL 2) Albumin g/l Bromocresol Green g/dl g/l Bromocresol Purple g/dl Alkaline Phosphatase U/l Roche Integra AMP buffer 37 C U/I Roche Integra AMP buffer 30 C U/I Roche Integra AMP buffer 25 C U/l Randox AMP 37 C U/I Randox AMP 30 C U/I Randox AMP 25 C ALT (GPT) U/l Tris buffer without P5P 37 C U/I Tris buffer without P5P 30 C U/I Tris buffer without P5P 25 C Amylase Pancreatic U/I Randox liquid stable pnpg7 37 C Amylase Total U/I Roche liquid stable pnpg7 37 C U/I Randox liquid stable pnpg7 37 C Acid Phosphatase (non-prostatic) U/I Naphthyl Phosphate, Kinetic with Pentane diol Activation 37 C U/I Naphthyl Phosphate substrate Kinetic 37 C Acid Phosphatase (Prostatic) U/I Naphthyl Phosphate, Kinetic with Pentane diol Activation 37 C U/I Naphthyl Phosphate substrate Kinetic 37 C Acid Phosphatase (Total) U/I Naphthyl Phosphate, Kinetic with Pentane diol Activation 37 C Page 1 of 6 30/04/2015

32 HITACHI SERIES ASSAYED HUMAN SERA LEVEL 2 (HUM ASY CONTROL 2) Acid Phosphatase (Total) U/I Naphthyl Phosphate substrate Kinetic 37 C AST (GOT) U/l Tris buffer without P5P 37 C U/I Tris buffer without P5P 30 C U/I Tris buffer without P5P 25 C Bile Acids µmol/l th Generation Colorimetric Bicarbonate mmol/l Colorimetric mmol/l Enzymatic Bilirubin Direct µmol/l Dichlorophenyl Diazonium (DPD) mg/dl µmol/l Diazo with Sulphanilic Acid mg/dl Bilirubin Total µmol/l Diazo with Dichloroaniline (DCA) mg/dl µmol/l Diazo with Sulphanilic Acid mg/dl µmol/l Dichlorophenyl Diazonium (DPD) mg/dl µmol/l Diazonium ion mg/dl µmol/l Oxidation to Biliverdin mg/dl Calcium mmol/l Cresolphthalein complexone mg/dl mmol/l Arsenazo III mg/dl Page 2 of 6 30/04/2015

33 HITACHI SERIES ASSAYED HUMAN SERA LEVEL 2 (HUM ASY CONTROL 2) Calcium mmol/l NM-BAPTA mg/dl Cholesterol mmol/l Cholesterol Oxidase mg/dl Chloride mmol/l ISE indirect Cholinesterase U/l Colorimetric Butyrylthiocholine 37 C CK Total U/l CK-NAC substrate start (DGKC) 37 C U/I CK-NAC substrate start (DGKC) 30 C U/I CK-NAC substrate start (DGKC) 25 C U/l CK-NAC (IFCC) 37 C U/I CK-NAC (IFCC) 30 C U/I CK-NAC (IFCC) 25 C Creatinine µmol/l Alkaline picrate no deproteinization mg/dl µmol/l Randox Enzymatic UV method mg/dl µmol/l Creatinine PAP method mg/dl µmol/l Roche Creatinine Plus mg/dl µmol/l Jaffe rate blanked comp. (-26 µmol/l) mg/dl µmol/l Jaffe rate blanked compensated (-18 µmol/l) mg/dl D-3-Hydroxybutyrate mmol/l Tris buffer 100mmol ph 8.5 Page 3 of 6 30/04/2015

34 HITACHI SERIES ASSAYED HUMAN SERA LEVEL 2 (HUM ASY CONTROL 2) gamma-gt U/I Gamma glutamyl.-3-carboxy-4-nitroanilide 37 C U/I Gamma glutamyl.-3-carboxy-4-nitroanilide 30 C U/I Gamma glutamyl.-3-carboxy-4-nitroanilide 25 C U/I Gamma Glutamyl-3-Carboxy-4-nitroanilide (IFCC) 37 C U/I Gamma Glutamyl-3-Carboxy-4-nitroanilide (IFCC) 30 C U/I Gamma Glutamyl-3-Carboxy-4-nitroanilide (IFCC) 25 C U/I Randox Gamma glutamyl.-3-carboxy-4-nitroanilide 37 C U/I Randox Gamma glutamyl.-3-carboxy-4-nitroanilide 30 C U/I Randox Gamma glutamyl.-3-carboxy-4-nitroanilide 25 C GLDH U/I Triethanolamine buffer 50 mmol 37 C U/I Triethanolamine buffer 50 mmol 30 C U/I Triethanolamine buffer 50 mmol 25 C Glucose mmol/l Hexokinase mg/dl mmol/l Glucose oxidase mg/dl alpha-hbdh U/I Oxobutyrate < 10 mmol/l 37 C U/I Oxobutyrate < 10 mmol/l 30 C U/I Oxobutyrate < 10 mmol/l 25 C HDL - Cholesterol mmol/l Direct HDL Immunoseparation mg/dl mmol/l Direct HDL PEGME mg/dl mmol/l Direct HDL Roche 3rd generation mg/dl Page 4 of 6 30/04/2015

35 HITACHI SERIES ASSAYED HUMAN SERA LEVEL 2 (HUM ASY CONTROL 2) Iron µmol/l Colorimetric without ppt. µg/dl Lactate mmol/l Colorimetric Lactate Oxidase mg/dl LD (LDH) U/l P->L German methods 37 C U/I P->L German methods 30 C U/I P->L German methods 25 C U/l L->P IFCC 37 C U/I L->P IFCC 30 C U/I L->P IFCC 25 C Lipase U/I Other Colorimetric 37 C U/I Roche Colorimetric 37 C Lithium mmol/l Spectrophotometric mg/dl Magnesium mmol/l Xylidyl Blue mg/dl mmol/l Chlorphosphonazo III mg/dl mmol/l Enzymatic mg/dl Phosphate Inorganic mmol/l Phosphomolybdate UV mg/dl Potassium mmol/l ISE method - indirect Protein Total g/l Biuret reaction end point g/dl Page 5 of 6 30/04/2015

36 HITACHI SERIES ASSAYED HUMAN SERA LEVEL 2 (HUM ASY CONTROL 2) Sodium mmol/l ISE method - indirect TIBC µmol/l FE+UIBC(saturation with iron) µg/dl Triglycerides mmol/l Lipase/GPO-PAP no correction mg/dl mmol/l Lipase/GPO-PAP 0.11mmol/l correction mg/dl mmol/l L/G Kinase EP. no correction mg/dl Uric Acid (Urate) mmol/l Uricase peroxidase with ascorbate oxidase mg/dl mmol/l Uricase peroxidase no ascorbate oxidase mg/dl mmol/l Uricase Peroxidase with ascorbate 546nm mg/dl Urea mmol/l Urease kinetic mg/dl mmol/l BUN mg/dl Page 6 of 6 30/04/2015

37 ILab 600 /650 /Aries ASSAYED HUMAN SERA LEVEL 2 (HUM ASY CONTROL 2) Albumin g/l Bromocresol Green g/dl Alkaline Phosphatase U/l AMP optimised to IFCC 37 C U/I AMP optimised to IFCC 30 C U/I AMP optimised to IFCC 25 C ALT (GPT) U/l Tris buffer without P5P 37 C U/I Tris buffer without P5P 30 C U/I Tris buffer without P5P 25 C AST (GOT) U/l Tris buffer without P5P 37 C U/I Tris buffer without P5P 30 C U/I Tris buffer without P5P 25 C Cholesterol mmol/l Cholesterol Oxidase mg/dl Chloride mmol/l ISE indirect CK Total U/l CK-NAC (IFCC) 37 C U/I CK-NAC (IFCC) 30 C U/I CK-NAC (IFCC) 25 C Creatinine µmol/l Alkaline picrate no deproteinization mg/dl D-3-Hydroxybutyrate mmol/l Tris buffer 100mmol ph 8.5 gamma-gt U/I Gamma glutamyl.-3-carboxy-4-nitroanilide 37 C U/I Gamma glutamyl.-3-carboxy-4-nitroanilide 30 C U/I Gamma glutamyl.-3-carboxy-4-nitroanilide 25 C Page 1 of 3 30/04/2015

38 ILab 600 /650 /Aries ASSAYED HUMAN SERA LEVEL 2 (HUM ASY CONTROL 2) gamma-gt U/I Gamma Glutamyl-3-Carboxy-4-nitroanilide (IFCC) 37 C U/I Gamma Glutamyl-3-Carboxy-4-nitroanilide (IFCC) 30 C U/I Gamma Glutamyl-3-Carboxy-4-nitroanilide (IFCC) 25 C GLDH U/I Triethanolamine buffer 50 mmol 37 C U/I Triethanolamine buffer 50 mmol 30 C U/I Triethanolamine buffer 50 mmol 25 C Glucose mmol/l Hexokinase mg/dl mmol/l Glucose oxidase mg/dl HDL - Cholesterol mmol/l Direct HDL Immunoseparation mg/dl LD (LDH) U/l P->L German methods 37 C U/I P->L German methods 30 C U/I P->L German methods 25 C Magnesium mmol/l Enzymatic mg/dl Phosphate Inorganic mmol/l Phosphomolybdate UV mg/dl Potassium mmol/l ISE method - indirect Protein Total g/l Biuret reaction end point g/dl Sodium mmol/l ISE method - indirect Page 2 of 3 30/04/2015

39 ILab 600 /650 /Aries ASSAYED HUMAN SERA LEVEL 2 (HUM ASY CONTROL 2) Triglycerides mmol/l Lipase/GPO-PAP no correction mg/dl mmol/l L/G Kinase EP. no correction mg/dl Uric Acid (Urate) mmol/l Uricase peroxidase no ascorbate oxidase mg/dl Urea mmol/l Urease end point mg/dl mmol/l BUN mg/dl Page 3 of 3 30/04/2015

40 JOHNSON AND JOHNSON VITROS ASSAYED HUMAN SERA LEVEL 2 (HUM ASY CONTROL 2) Albumin g/l Ortho Vitros Microslide Systems g/dl Alkaline Phosphatase U/l Ortho Vitros Microslide Systems 37 C ALT (GPT) U/l Ortho Vitros Microslide Systems 37 C Amylase Total U/I Ortho Vitros Microslide Systems 37 C AST (GOT) U/l Ortho Vitros Microslide visible slide 37 C Bicarbonate mmol/l Ortho Vitros Microslide Systems Bilirubin Total µmol/l Vitros 250/500/700/950 Total Bilirubin mg/dl µmol/l Vitros 250/500/700/950 Total BUBC mg/dl Calcium mmol/l Ortho Vitros Microslide Systems mg/dl mmol/l Vitros DT60/DT60 II/DTSC II mg/dl Cholesterol mmol/l Ortho Vitros Microslide Systems mg/dl mmol/l Vitros DT60/DT60 II mg/dl Chloride mmol/l Ortho Vitros Microslide Systems mmol/l Vitros DT60/DT60 II/DTE II Page 1 of 4 30/04/2015

41 JOHNSON AND JOHNSON VITROS ASSAYED HUMAN SERA LEVEL 2 (HUM ASY CONTROL 2) Cholinesterase U/l Ortho Vitros Microslide Systems 37 C CK Total U/l Ortho Vitros Microslide Systems 37 C U/l Vitros DT60/DT60 II/DTSC II 37 C Creatinine µmol/l Vitros IDMS Traceable mg/dl Free T4 pmol/l Vitros ECi ng/dl pg/ml Vitros ECi gamma-gt U/I Ortho Vitros Microslide Systems 37 C U/I Vitros DT60/DT60 II/DTSC II 37 C Glucose mmol/l Ortho Vitros Microslide Systems mg/dl mmol/l Vitros DT60/DT60 II mg/dl HDL - Cholesterol mmol/l Vitros Magnetic HDL mg/dl mmol/l Vitros dhdl PTA/MgCl2 direct precipitation mg/dl Iron µmol/l Ortho Vitros Microslide Systems µg/dl Lactate mmol/l Ortho Vitros Microslide Systems mg/dl LD (LDH) U/l Ortho Vitros Microslide Systems 37 C U/l Vitros DT60/DT60 II/DTSC II 37 C Lipase U/I Ortho Vitros Microslide Systems 37 C Page 2 of 4 30/04/2015