LIQUID ASSAYED CHEMISTRY CONTROL PREMIUM PLUS - LEVEL 1 (LIQ CHEM ASY PREMIUM PLUS 1)

Transcription

1 0086 LIQUID ASSAYED CHEMISTRY CONTROL PREMIUM PLUS - LEVEL 1 (LIQ CHEM ASY PREMIUM PLUS 1) CAT. NO. LAL 4213 LOT NO. 238UL SIZE: 12 x 5 ml EXPIRY: GTIN: INTENDED USE This product is intended for in vitro diagnostic use, in the quality control of diagnostic assays. The Liquid Assayed Chemistry Control Premium Plus is for the control of accuracy. DEVICE DESCRIPTION The Liquid Assayed Chemistry Control Premium Plus is supplied at 3 levels, level 1, 2 and 3. Target values and ranges are supplied for the analytes listed in the values section at all three 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 (+2ºC to + 8ºC). Thawed serum is stable for 7 days at +2ºC to +8ºC, with the following exceptions: Troponin T is stable for 3 days at +2ºC to +8ºC. Only the required amount of product should be removed. After use, any residual product should NOT BE RETURNED to the original vial. UNOPENED: Store frozen at 20ºC to 70ºC. Stable to expiration date printed on individual vials (see Limitations). LIMITATIONS For Total Acid Phosphatase, the material should be stabilised by adding 1 drop (25 µl - 30 µl) of 0.7M Acetic acid solution to 1 ml of the serum after thawing. After stabilisation, Total Acid Phosphatase is stable for 7 days at +2ºC to +8ºC. Bilirubin in the serum is light sensitive and it is recommended that the serum is stored in the dark. ALT, Total Acid Phosphatase, Alkaline Phosphatase, Total and Direct Bilirubin values may gradually decrease during the products shelf life. Bacterial contamination of the thawed serum will cause reductions in the stability of many components. The control should not be used as a calibration material. PREPARATION 1. Allow the frozen control to thaw at room temperature (+15ºC to +25ºC) until completely thawed. Swirl the contents to ensure homogeneity. 2. Refer to the Control section of the individual analyser application. 3. Refrigerate any unused material. Prior to reuse, mix contents thoroughly. MATERIALS PROVIDED Liquid Assayed Chemistry Control Premium Plus - Level 1 12 x 5 ml MATERIALS REQUIRED BUT NOT PROVIDED None ASSIGNED VALUES Each lot of serum is submitted to a number of external laboratories. Values are assigned from a consensus of results obtained by these laboratories and internal testing conducted at Randox Laboratories Ltd. With each batch, a control range is provided for individual parameters and each parameter method. If an instrument specific value is not available, refer to the Mean of all Instruments section. If necessary, contact Randox Laboratories - Customer Technical Services, Northern Ireland, tel: +44 (0) or Technical.Services@randox.com. Rev. 04 Jul 16 ne PAGE 1 OF 29

2 Abbott Architect c/ci Systems (LIQ CHEM ASY PREMIUM PLUS 1) Alkaline Phosphatase U/l AMP optimised to IFCC 37 C ALT (GPT) U/l Tris buffer without P5P 37 C Amylase Total U/I Abbott Architect 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 Calcium mmol/l Arsenazo III mg/dl Chloride mmol/l ISE indirect Cholesterol mmol/l Cholesterol Oxidase mg/dl Creatinine µmol/l Alkaline picrate no deproteinization mg/dl gamma-gt U/I Gamma Glutamyl-3-Carboxy-4-nitroanilide (IFCC) 37 C Glucose mmol/l Hexokinase mg/dl Iron µmol/l Colorimetric without ppt. µg/dl LD (LDH) U/l L->P IFCC 37 C Page 2 of 29 04/07/2016

3 Abbott Architect c/ci Systems (LIQ CHEM ASY PREMIUM PLUS 1) Magnesium mmol/l Enzymatic mg/dl Phosphate Inorganic mmol/l Phosphomolybdate UV mg/dl Potassium mmol/l ISE indirect Protein Total g/l Biuret reaction end point g/dl Sodium mmol/l ISE indirect Triglycerides mmol/l Lipase/GPO-PAP no correction mg/dl Urea mmol/l Urease kinetic mg/dl mmol/l BUN mg/dl Uric Acid (Urate) mmol/l Uricase peroxidase no ascorbate oxidase mg/dl Page 3 of 29 04/07/2016

4 Beckman Coulter AU Series (LIQ CHEM ASY PREMIUM PLUS 1) 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 Bicarbonate mmol/l Enzymatic Bilirubin Direct µmol/l Diazo with Sulphanilic Acid mg/dl Bilirubin Total µmol/l Dichlorophenyl Diazonium (DPD) mg/dl Calcium mmol/l Arsenazo III mg/dl Chloride mmol/l ISE indirect CK Total U/l CK-NAC (IFCC) 37 C Creatinine µmol/l Jaffe rate blanked mg/dl gamma-gt U/I Gamma Glutamyl-3-Carboxy-4-nitroanilide (IFCC) 37 C Glucose mmol/l Hexokinase mg/dl Iron µmol/l Colorimetric without ppt. µg/dl Page 4 of 29 04/07/2016

5 Beckman Coulter AU Series (LIQ CHEM ASY PREMIUM PLUS 1) LD (LDH) U/l L->P IFCC 37 C Magnesium mmol/l Xylidyl Blue mg/dl Phosphate Inorganic mmol/l Phosphomolybdate UV mg/dl Potassium mmol/l ISE indirect Protein Total g/l Biuret reaction end point g/dl Sodium mmol/l ISE indirect Urea mmol/l Urease kinetic mg/dl mmol/l BUN mg/dl Uric Acid (Urate) mmol/l Uricase peroxidase with ascorbate oxidase mg/dl Page 5 of 29 04/07/2016

6 JOHNSON AND JOHNSON VITROS (LIQ CHEM ASY PREMIUM PLUS 1) 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 AST (GOT) U/l Ortho Vitros Microslide Systems 37 C Bilirubin Total µmol/l Ortho Vitros Microslide Systems mg/dl Calcium mmol/l Ortho Vitros Microslide Systems mg/dl Chloride mmol/l Ortho Vitros Microslide Systems Cholesterol mmol/l Ortho Vitros Microslide Systems mg/dl CK Total U/l Ortho Vitros Microslide Systems 37 C Creatinine µmol/l Ortho Vitros Microslide Systems mg/dl gamma-gt U/I Ortho Vitros Microslide Systems 37 C Glucose mmol/l Ortho Vitros Microslide Systems mg/dl Iron µmol/l Ortho Vitros Microslide Systems µg/dl LD (LDH) U/l Ortho Vitros Microslide Systems 37 C Page 6 of 29 04/07/2016

7 JOHNSON AND JOHNSON VITROS (LIQ CHEM ASY PREMIUM PLUS 1) Magnesium mmol/l Ortho Vitros Microslide Systems mg/dl Phosphate Inorganic mmol/l Ortho Vitros Microslide Systems mg/dl Potassium mmol/l Ortho Vitros Microslide Systems Protein Total g/l Ortho Vitros Microslide Systems g/dl Sodium mmol/l Ortho Vitros Microslide Systems Triglycerides mmol/l Ortho Vitros Microslide Systems mg/dl Urea mmol/l Ortho Vitros Microslide Systems mg/dl mmol/l BUN mg/dl Uric Acid (Urate) mmol/l Ortho Vitros Microslide Systems mg/dl Page 7 of 29 04/07/2016

8 MEAN OF ALL INSTRUMENTS (LIQ CHEM ASY PREMIUM PLUS 1) 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 Acid Phosphatase (Total) U/I Naphthyl Phosphate substrate Kinetic 37 C U/I Naphthyl Phosphate, Kinetic with Pentane diol Activation 37 C Albumin g/l Bromocresol Green g/dl g/l Bromocresol Purple g/dl Alkaline Phosphatase U/l p-nitrophenylphosphate AMP 37 C U/I p-nitrophenylphosphate AMP 30 C U/I p-nitrophenylphosphate AMP 25 C U/l Diethanolamine buffer DEA 37 C U/I Diethanolamine buffer DEA 30 C U/I Diethanolamine buffer DEA 25 C U/l AMP optimised to IFCC 37 C U/I AMP optimised to IFCC 30 C U/I AMP optimised to IFCC 25 C Alpha-1-Acid Glycoprotein g/l Immunoturbidimetric mg/dl Alpha-1-Antitrypsin g/l Immunoturbidimetric mg/dl Page 8 of 29 04/07/2016

9 MEAN OF ALL INSTRUMENTS (LIQ CHEM ASY PREMIUM PLUS 1) Alphafoetoprotein KIU/l = Roche Cobas E411 ng/ml ALT (GPT) U/l Tris buffer with P5P 37 C U/I Tris buffer with P5P 30 C U/I Tris buffer with P5P 25 C U/l Tris buffer without P5P 37 C U/I Tris buffer without P5P 30 C U/I Tris buffer without P5P 25 C Amikacin µmol/l Enzyme Immunoassay µg/ml Amylase Pancreatic U/I Randox liquid stable pnpg7 37 C Amylase Total U/I Randox - Ethylidene pnpg7 37 C U/I Randox liquid stable pnpg7 37 C U/I pnp Maltotrioside substrates 37 C U/I Siemens 2-chloro-pNPG3 37 C U/I Roche liquid stable pnpg7 37 C Apolipoprotein A-1 g/l Immunoturbidimetric mg/dl Apolipoprotein B g/l Immunoturbidimetric mg/dl AST (GOT) U/l Tris buffer with P5P 37 C U/I Tris buffer with P5P 30 C U/I Tris buffer with P5P 25 C U/l Tris buffer without P5P 37 C U/I Tris buffer without P5P 30 C U/I Tris buffer without P5P 25 C Page 9 of 29 04/07/2016

10 MEAN OF ALL INSTRUMENTS (LIQ CHEM ASY PREMIUM PLUS 1) Beta-2-microglobulin µg/ml = Immunoturbidimetric Bicarbonate mmol/l Enzymatic Bile Acids µmol/l th Generation Colorimetric µmol/l th Generation Colorimetric Bilirubin Direct µmol/l Modified Jendrassik mg/dl µmol/l Diazo with Sulphanilic Acid mg/dl µmol/l Oxidation to Biliverdin/Vanadate mg/dl µmol/l Dichlorophenyl Diazonium (DPD) mg/dl Bilirubin Total µmol/l Diazo with Dichloroaniline (DCA) mg/dl µmol/l Dichlorophenyl Diazonium (DPD) mg/dl µmol/l Modified Jendrassik mg/dl µmol/l Diazo with Sulphanilic Acid mg/dl µmol/l Oxidation to Biliverdin/Vanadate mg/dl C-Reactive Protein mg/l Immunoturbidimetric Page 10 of 29 04/07/2016

11 MEAN OF ALL INSTRUMENTS (LIQ CHEM ASY PREMIUM PLUS 1) Caeruloplasmin g/l Immunoturbidimetric mg/dl Caffeine µmol/l Enzyme Immunoassay µg/ml Calcium mmol/l Arsenazo III mg/dl mmol/l Cresolphthalein complexone mg/dl mmol/l NM-BAPTA mg/dl Carbamazepine µmol/l Immunoturbidimetric µg/ml Carcinoembryonic Antigen (CEA) ng/ml = Roche Cobas E411 Chloride mmol/l Colorimetric mmol/l ISE indirect mmol/l ISE direct Cholesterol mmol/l Cholesterol Oxidase mg/dl Cholinesterase U/l Colorimetric Butyrylthiocholine 37 C CK Total U/l CK-NAC (IFCC) 37 C U/I CK-NAC (IFCC) 30 C U/I CK-NAC (IFCC) 25 C 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 Page 11 of 29 04/07/2016

12 MEAN OF ALL INSTRUMENTS (LIQ CHEM ASY PREMIUM PLUS 1) CK Total U/l CK-NAC serum start (DGKC) 37 C U/I CK-NAC serum start (DGKC) 30 C U/I CK-NAC serum start (DGKC) 25 C Complement C3 g/l Immunoturbidimetric mg/dl Complement C4 g/l Immunoturbidimetric mg/dl Copper µmol/l Colorimetric µg/dl Cortisol nmol/l Roche Cobas E411 µg/dl Creatinine µmol/l Randox Enzymatic UV method mg/dl µmol/l Jaffe rate blanked mg/dl µmol/l Alkaline picrate no deproteinization mg/dl µmol/l Jaffe rate blanked comp. (-26 µmol/l) mg/dl D-3-Hydroxybutyrate mmol/l Tris buffer 100mmol ph 8.5 DHEA-S µmol/l Siemens Immulite 2000 Digoxin nmol/l Immunoturbidimetric ng/ml Ethanol mg/dl Enzyme Immunoassay Ferritin ng/ml = Immunoturbidimetric Page 12 of 29 04/07/2016

13 MEAN OF ALL INSTRUMENTS (LIQ CHEM ASY PREMIUM PLUS 1) Folate nmol/l Roche Cobas E411 ng/ml Free T3 pmol/l Roche Cobas E411 ng/dl Roche Cobas E411 pg/ml Roche Cobas E411 Free T4 pmol/l Roche Cobas E411 ng/dl Roche Cobas E411 pg/ml Roche Cobas E411 FSH mu/ml Roche Cobas E411 Gentamicin µmol/l Immunoturbidimetric µg/ml 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 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 Haptoglobin g/l Immunoturbidimetric mg/dl Page 13 of 29 04/07/2016

14 MEAN OF ALL INSTRUMENTS (LIQ CHEM ASY PREMIUM PLUS 1) HDL - Cholesterol mmol/l Direct Clearance Method mg/dl Immunoglobulin A g/l Immunoturbidimetric mg/dl Immunoglobulin E KIU/l = Immunoturbidimetric Immunoglobulin G g/l Immunoturbidimetric mg/dl Immunoglobulin M g/l Immunoturbidimetric mg/dl Iron µmol/l Colorimetric without ppt. µg/dl Lactate mmol/l Colorimetric Lactate Oxidase mg/dl LAP U/l NAGEL 37 C LD (LDH) U/l L->P IFCC 37 C U/I L->P IFCC 30 C U/I L->P IFCC 25 C 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 37 C U/I L->P 30 C U/I L->P 25 C LDL - Cholesterol mmol/l Direct Clearance Method mg/dl Page 14 of 29 04/07/2016

15 MEAN OF ALL INSTRUMENTS (LIQ CHEM ASY PREMIUM PLUS 1) Lipase U/I Randox Turbidimetric with colipase 37 C U/I Randox Colorimetric 37 C Lipoprotein (a) mg/dl Immunoturbidimetric nmol/l Lithium mmol/l Randox Colorimetric mg/dl Luteinising Hormone (LH) mu/ml Roche Cobas E411 Magnesium mmol/l Xylidyl Blue mg/dl mmol/l Methylthymol blue mg/dl Myoglobin ng/ml = Immunoturbidimetric Osmolality mosm/kg Freezing point depression Paracetamol mmol/l Colorimetric mg/l Phenobarbital µmol/l Immunoturbidimetric µg/ml Phenytoin µmol/l Immunoturbidimetric µg/ml Phosphate Inorganic mmol/l Phosphomolybdate UV mg/dl Potassium mmol/l Enzymatic mmol/l ISE indirect mmol/l ISE direct Page 15 of 29 04/07/2016

16 MEAN OF ALL INSTRUMENTS (LIQ CHEM ASY PREMIUM PLUS 1) Prealbumin g/l Immunoturbidimetric mg/dl Progesterone nmol/l Roche Cobas E411 ng/ml Prolactin µu/ml Roche Cobas E411 Protein Total g/l Biuret reaction end point g/dl PSA Total ng/ml = Roche Cobas E411 Salicylate mmol/l Enzymatic mg/dl Sodium mmol/l Enzymatic mmol/l ISE indirect mmol/l ISE direct T Uptake %U Siemens Immulite 2000 Testosterone nmol/l Roche Cobas E411 ng/ml Roche Cobas E411 ng/dl Roche Cobas E411 Theophylline µmol/l Immunoturbidimetric µg/ml Thyroid Stimulating Hormone µu/ml = Roche Cobas E411 TIBC µmol/l Randox Direct µg/dl Total Beta hcg mu/ml=iu Roche Cobas E411 IU/ml Total T3 nmol/l Roche Cobas E411 ng/ml Roche Cobas E411 ng/dl Roche Cobas E411 Page 16 of 29 04/07/2016

17 MEAN OF ALL INSTRUMENTS (LIQ CHEM ASY PREMIUM PLUS 1) Total T4 nmol/l Roche Cobas E411 µg/dl Roche Cobas E411 ng/ml Roche Cobas E411 Transferrin g/l Immunoturbidimetric mg/dl Triglycerides mmol/l Lipase/GPO-PAP no correction mg/dl Troponin T µg/l Roche Cobas Troponin T HS pg/ml Urea mmol/l Urease - hypochlorite mg/dl mmol/l Urease kinetic mg/dl mmol/l BUN mg/dl mmol/l Urease Berthelot mg/dl Uric Acid (Urate) mmol/l Uricase peroxidase with ascorbate oxidase mg/dl mmol/l Uricase Peroxidase with ascorbate 546nm mg/dl mmol/l Uricase peroxidase no ascorbate oxidase mg/dl Page 17 of 29 04/07/2016

18 MEAN OF ALL INSTRUMENTS (LIQ CHEM ASY PREMIUM PLUS 1) Uric Acid (Urate) mmol/l Spectrophotometric at mg/dl Valproic Acid µmol/l Immunoturbidimetric µg/ml Vancomycin µmol/l Immunoturbidimetric µg/ml Vitamin B12 pmol/l Roche Cobas E411 pg/ml Zinc µmol/l Colorimetric with deproteinisation µg/dl Page 18 of 29 04/07/2016

19 MEAN OF ALL INSTRUMENTS (Elec.) (LIQ CHEM ASY PREMIUM PLUS 1) Albumin (electrophoresis) % of total Protein (Beckman Capillary) alpha-1-globulin % of total Protein (Beckman Capillary) alpha-2-globulin % of total Protein (Beckman Capillary) beta-globulin % of total Protein (Beckman Capillary) gamma-globulin % of total Protein (Beckman Capillary) Page 19 of 29 04/07/2016

20 ROCHE COBAS SERIES (LIQ CHEM ASY PREMIUM PLUS 1) Albumin g/l Bromocresol Green 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 Total 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 Bilirubin Total µmol/l Dichlorophenyl Diazonium (DPD) mg/dl Calcium mmol/l NM-BAPTA mg/dl Cholesterol mmol/l Cholesterol Oxidase mg/dl Page 20 of 29 04/07/2016

21 ROCHE COBAS SERIES (LIQ CHEM ASY PREMIUM PLUS 1) 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 Roche Creatinine Plus mg/dl 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 Glucose mmol/l Hexokinase mg/dl Iron µmol/l Colorimetric without ppt. µg/dl LD (LDH) U/l L->P IFCC 37 C U/I L->P IFCC 30 C U/I L->P IFCC 25 C Magnesium mmol/l Xylidyl Blue mg/dl Phosphate Inorganic mmol/l Phosphomolybdate UV mg/dl Potassium mmol/l ISE indirect Protein Total g/l Biuret reaction end point g/dl Sodium mmol/l ISE indirect Triglycerides mmol/l Lipase/GPO-PAP no correction mg/dl Page 21 of 29 04/07/2016

22 ROCHE COBAS SERIES (LIQ CHEM ASY PREMIUM PLUS 1) 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 22 of 29 04/07/2016

23 RX SERIES (LIQ CHEM ASY PREMIUM PLUS 1) Albumin g/l Bromocresol Green g/dl Alkaline Phosphatase U/l AMP optimised to IFCC 37 C U/l Diethanolamine buffer DEA 37 C ALT (GPT) U/l Tris buffer without P5P 37 C Amylase Pancreatic U/I Randox liquid stable pnpg7 37 C Amylase Total U/I Randox liquid stable pnpg7 37 C AST (GOT) U/l Tris buffer without P5P 37 C Bicarbonate mmol/l Enzymatic Bile Acids µmol/l th Generation Colorimetric Bilirubin Direct µmol/l Diazo with Sulphanilic Acid mg/dl µmol/l Vanadate Oxidation mg/dl Bilirubin Total µmol/l Diazo with Sulphanilic Acid mg/dl µmol/l Vanadate Oxidation mg/dl Calcium mmol/l Arsenazo III mg/dl Chloride mmol/l ISE direct Page 23 of 29 04/07/2016

24 RX SERIES (LIQ CHEM ASY PREMIUM PLUS 1) Cholesterol mmol/l Cholesterol Oxidase mg/dl CK Total U/l CK-NAC (IFCC) 37 C U/l CK-NAC substrate start (DGKC) 37 C Creatinine µmol/l Alkaline picrate no deproteinization mg/dl µmol/l Randox Enzymatic UV method mg/dl gamma-gt U/I Gamma Glutamyl-3-Carboxy-4-nitroanilide (IFCC) 37 C Glucose mmol/l Hexokinase mg/dl mmol/l Glucose oxidase mg/dl Iron µmol/l Colorimetric without ppt. µg/dl Lactate mmol/l Colorimetric Lactate Oxidase mg/dl LD (LDH) U/l L->P IFCC 37 C U/l P->L German methods 37 C Lipase U/I Randox Colorimetric 37 C Lithium mmol/l Colorimetric mg/dl Magnesium mmol/l Xylidyl Blue mg/dl Phosphate Inorganic mmol/l Phosphomolybdate UV mg/dl Page 24 of 29 04/07/2016

25 RX SERIES (LIQ CHEM ASY PREMIUM PLUS 1) Potassium mmol/l Enzymatic mmol/l ISE direct Protein Total g/l Biuret reaction end point g/dl Sodium mmol/l Enzymatic mmol/l ISE direct TIBC µmol/l Direct Colorimetric µg/dl Triglycerides mmol/l Lipase/GPO-PAP no correction mg/dl Urea mmol/l Urease kinetic mg/dl mmol/l BUN mg/dl Uric Acid (Urate) mmol/l Uricase Peroxidase with ascorbate 546nm mg/dl mmol/l Uricase peroxidase no ascorbate oxidase mg/dl Page 25 of 29 04/07/2016

26 SIEMENS ADVIA 1200/1650/1800/2400 (LIQ CHEM ASY PREMIUM PLUS 1) Albumin g/l Bromocresol Green g/dl Alkaline Phosphatase U/l p-nitrophenylphosphate AMP 37 C U/l Diethanolamine buffer DEA 37 C ALT (GPT) U/l Tris buffer without P5P 37 C Amylase Total U/I pnp Maltotrioside substrates 37 C AST (GOT) U/l Tris buffer without P5P 37 C Bilirubin Direct µmol/l Oxidation to Biliverdin/Vanadate mg/dl Bilirubin Total µmol/l Oxidation to Biliverdin/Vanadate mg/dl Calcium mmol/l Cresolphthalein complexone mg/dl mmol/l Arsenazo III mg/dl Cholesterol mmol/l Cholesterol Oxidase mg/dl CK Total U/l CK-NAC serum start (DGKC) 37 C Creatinine µmol/l Jaffe rate blanked comp. (-26 µmol/l) mg/dl gamma-gt U/I Gamma Glutamyl-3-Carboxy-4-nitroanilide (IFCC) 37 C Page 26 of 29 04/07/2016

27 SIEMENS ADVIA 1200/1650/1800/2400 (LIQ CHEM ASY PREMIUM PLUS 1) Glucose mmol/l Hexokinase mg/dl mmol/l Glucose oxidase mg/dl Iron µmol/l Colorimetric without ppt. µg/dl LD (LDH) U/l L->P 37 C U/l P->L German methods 37 C 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 Triglycerides mmol/l Lipase/GPO-PAP no correction mg/dl Urea mmol/l Urease kinetic mg/dl mmol/l BUN mg/dl Uric Acid (Urate) mmol/l Uricase Peroxidase with ascorbate 546nm mg/dl Page 27 of 29 04/07/2016

28 SIEMENS DIMENSION SERIES (LIQ CHEM ASY PREMIUM PLUS 1) Albumin g/l Bromocresol Purple g/dl Alkaline Phosphatase U/l AMP optimised to IFCC 37 C ALT (GPT) U/l Siemens Dade Standard Non IFCC Correlated 37 C Amylase Total U/I Siemens 2-chloro-pNPG3 37 C AST (GOT) U/l Siemens Dade Standard Non IFCC Correlated 37 C Bilirubin Total µmol/l Diazo with Sulphanilic Acid mg/dl Calcium mmol/l Cresolphthalein complexone mg/dl Chloride mmol/l ISE indirect Cholesterol mmol/l Dimension-Siemens reagents mg/dl CK Total U/l CK-NAC (IFCC) 37 C Creatinine µmol/l Alkaline picrate no deproteinization mg/dl gamma-gt U/I Gamma Glutamyl-3-Carboxy-4-nitroanilide (IFCC) 37 C Glucose mmol/l Hexokinase mg/dl LD (LDH) U/l L->P IFCC 37 C Magnesium mmol/l Methylthymol blue mg/dl Page 28 of 29 04/07/2016

29 SIEMENS DIMENSION SERIES (LIQ CHEM ASY PREMIUM PLUS 1) Phosphate Inorganic mmol/l Phosphomolybdate UV mg/dl Potassium mmol/l ISE indirect Protein Total g/l Biuret reaction end point g/dl Sodium mmol/l ISE indirect Urea mmol/l Urease kinetic mg/dl mmol/l BUN mg/dl Uric Acid (Urate) mmol/l Spectrophotometric at mg/dl Page 29 of 29 04/07/2016