TRACEABILITY and UNCERTAINTY 7

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1 cobas c 01 / c 02 / c 11 / c 701 / c C.f.a.s. Cat. No ACP2 Acid phosphatase total 1-naphthyl phosphate Gen. 2 ACP2 Acid phosphatase, non-prostatic 1-naphthyl phosphate (Inhib.:tartrate) Gen. 2 ALB2 Albumin BCG Gen. 2 ALBP Albumin BCP ALP2L Alkaline Phosphatase IFCC Gen. 2 ALP2S Alkaline Phosphatase IFCC Gen. 2 cobas c 01, c 02, c 11 ALTLP/ALTPM Alanine Aminotransferase IFCC with pyridoxal phosphate ALTL/ALT Alanine Aminotransferase IFCC without pyridoxal phosphate AMYL2 Amylase alpha IFCC liquid ver. 2 AMYL2 Amylase alpha IFCC liquid ver. 2 AMY-P Amylase pancreatic alpha EPS ver. 2 c 01/11: 021 c 02: /702: c 01/11: 022 c 02/701/702: g/dl g/l g/dl g/l c 01/11: 1 c 02/701/702: 81 ERM-DA70k/IFCC 6 c 01/11: 760 c 02/701/702: 8760 ERM-DA70k/IFCC 6 c 01/11: 68 c 02/701/702: 868 IFCC (198), manual c 01/11: 18 c 02: 818 IFCC (198), manual c 01/11: 68 c 02/701/702: 8681 c 01/11: 68 c 02/701/702: 868 c 01/11: 70 c 02/701/702: 870 c 01/11: 66 c 02/701/702: 866 c 01/11: 71 c 02/701/702: 871 IFCC (2002) modified, manual Roche reagent according to IFCC (1998), manual Roche reagent according to IFCC (1998), manual

2 cobas c 01 / c 02 / c 11 / c 701 / c C.f.a.s. Cat. No ASTLP/ASTPM Aspartate aminotransferase IFCC with pyridoxal phosphate ASTL/AST Aspartate aminotransferase IFCC without pyridoxal phosphate ASTL/AST Aspartate aminotransferase IFCC without pyridoxal phosphate BILD2 Bilirubin direct, Diazo Gen. 2 Jendrassik-Grof cobas c 01/ c 02 / c 11 BILD2 Bilirubin direct, Diazo Gen. 2 Doumas cobas c 01/ c 02 / c 11 BILD2 Bilirubin direct, DiazoGen. 2 Jendrassik-Grof BILD2 Bilirubin direct, DiazoGen. 2 Doumas BILT2 Bilirubin total DPD Gen. 2 cobas c 01/ c 02 / c 11 BILT2 Bilirubin total DPD Gen. 2 cobas c 01/ c 02 / c 11 c 01/11: 686 c 02/701/702: 8680 c 01/11: 687 c 02/701/702: 8687 c 01/11: 87 c 02/701/702: 887 IFCC (2002) modified, manual IFCC (2002) modified, manual c 01/11: 7 c 02: c 01/11: 7 c 02: c 701/702: c 701/702: c 01/11: 27 c 02: c 01/11: 27 c 02:

3 cobas c 01 / c 02 / c 11 / c 701 / c C.f.a.s. Cat. No BILT2 Bilirubin total DPD Gen. 2 BILT2 Bilirubin total DPD Gen. 2 BILT Bilirubin total Gen. cobas c 01/ c 02 / c 11 BILT Bilirubin total Gen. cobas c 01/ c 02 / c 11 BILT Bilirubin total Gen. BILT Bilirubin total Gen. BUN Blood urea nitrogen Urease/GLDH BUN Blood urea nitrogen Urease/GLDH Ca2 Calcium -Nitro- -methyl-bapta Ca2 Calcium -Nitro- -methyl-bapta c 701/702: c 701/702: c 01/11: 712 c 02: c 01/11: 711 c 02: c 701/702: c 701/702: c 01/11: 21 c 02/701/702: 821 c 01/11: 27 c 02/701/702: 827 c 01/11: 698 c 02/701/702: 8698 SRM 96c L2 c 01/11: 699 c 02/701/702: 8699 SRM 96c L2

4 cobas c 01 / c 02 / c 11 / c 701 / c C.f.a.s. Cat. No CHE2 Cholinesterase butyrylthiocholine Gen. 2 cobas c 01/ c 02 / c 11 CHE Cholinesterase acethylthiocholine cobas c 01/ c 02 / c 11 CHED2/CHE2 Cholinesterase butyrylthiocholine Gen. 2 CHOL2 Cholesterol CHOD-PAP Gen. 2 stand. ID/MS CK/CKL Creatine kinase IFCC liquid CK2 Creatine kinase IFCC liquid CREP2 plus ver. 2 Jaffé compensated Gen. 2 serum, plasma Jaffé Gen. 2 urine cobas c 01/ c 02 Jaffé Gen. 2 urine cobas c 11 c 01/11: 10 c 02: c 01/11: 72 c 02: c 01/11: c 02/701/702: c 01/11: 798 c 02/701/702: 8798 c 01/11: 07 c 02/701/702: 807 c 01/11: 0 c 02/701/702: c 01/11: 2 c 02/701/702: 82 c 01/11: 77 c 02/701/702: c 01: 77 c 02: c 11:

5 cobas c 01 / c 02 / c 11 / c 701 / c C.f.a.s. Cat. No Jaffé Gen. 2 urine Jaffé rate-blanked and compensated Gen. 2 serum, plasma Jaffé rate-blanked and compensated Gen. 2 urine Jaffé rate-blanked and compensated Gen. 2 urine GGT-2 Glutamyltransferase gamma liquid stand. Szasz GGT-2 Glutamyltransferase gamma liquid stand. IFCC GLDH Glutamate dehydrogenase opt. (DGKC) Gen. GLUC2 Glucose HK cobas c 01/ c 02 / c 11 GLUC2 Glucose HK cobas c 01/ c 02 / c 11 c 701/702: c 01/11: 690 c 02/701/702: c 01/11: 691 c 02: c 701/702: c 01/11: 80 c 02/701/702: 880 c 01/11: 220 c 02/701/702: 8220 Persijn/v.d. Slik (1976), manual c 01/11: 88 c 02/701/702: 888 c 01/11: 767 c 02: 8767 c 01/11: 2 c 02: 82

6 cobas c 01 / c 02 / c 11 / c 701 / c C.f.a.s. Cat. No GLUC Glucose HK GLUC Glucose HK GLUC2 Glucose ver. 2 HK hemolysate Gen. 2 GLUC2 Glucose ver. 2 HK hemolysate Gen. 2 HBDH2 Hydroxybutyrate dehydrogenase alpha opt. (DGKC) Gen. 2 IRON2 Iron FerroZine Gen. 2 LACT2 Lactate enzymatic colorimetric test Gen. 2 cobas c 01/ c 02 / c 11 LACT2 Lactate enzymatic colorimetric test Gen. 2 cobas c 01/ c 02 / c 11 LACT2 Lactate enzymatic colorimetric test Gen SRM µg/dl c 01/11: 00 c 02: c 01/11: 07 c 02: c 701/702: c 01/11: 717 c 02/701/702: 8717 c 01/11: 668 c 02/701/702: 8668 c 01/11: 09 c 02/701/702: 809 c 01/11: 08 c 02/701/702: 808 c 01/11: 67 c 02/701/702: 867 c 01/11: 611 c 02/701/702: 8661

7 cobas c 01 / c 02 / c 11 / c 701 / c C.f.a.s. Cat. No LACT2 Lactate enzymatic colorimetric test Gen. 2 LDHI2 Lactate dehydrogenase IFCC liquid ver. 2 LDHI2 Lactate dehydrogenase IFCC liquid ver. 2 sample predilution LDHL Lactate dehydrogenase opt. (DGKC) cobas c 01/ c 02 / c 11 LIPC Lipase enzymatic colorimetric test LIPC Lipase enzymatic colorimetric test LI Lithium colorimetric test MG2 Magnesium xylidyl blue method serum, plasma cobas c 01, c 02, c 11 MG2 Magnesium xylidyl blue method serum, plasma cobas c 01, c 02, c 11 c 701/702: c 01/11: 080 c 02/701/702: c 01/11: 17 c 02/701/702: c 01/11: 672 c 02: c 01/11: 71 c 02/701/702: c 01/11: 7 c 02/701/702: c 01/11: 16 c 02/701/702: 816 Flame photometry c 01/11: 701 c 02: 8701 Atomic absorption c 01/11: 688 c 02: 8688 Atomic absorption

8 cobas c 01 / c 02 / c 11 / c 701 / c C.f.a.s. Cat. No MG2 Magnesium xylidyl blue method serum, plasma cobas c 701, c 702 MG2 Magnesium xylidyl blue method serum, plasma cobas c 701, c 702 Atomic absorption Atomic absorption g/dl g/l g/dl g/l c 701/702: 8701 c 701/702: 8688 c 01/11: 71 c 02/701/702: 871 PHOS2 Phosphate (inorganic) molybdate UV ver. 2 c 01/11: 67 c 02/701/702: 867 TRIGL Triglycerides GPO-PAP TRIGB Triglycerides/Glycerol Blanked glycerol blanked TP2 Total protein Biuret Gen. 2 TP2 Total protein Biuret Gen. 2 UA2 Uric acid enzymatic colorimetric test ver. 2 PHOS2 Phosphate (inorganic) molybdate UV ver. 2 c 01/11: 781 c 02/701/702: 8781 material (NERL) (weighed in purified material) material (NERL) (weighed in purified material) c 01/11: 78 c 02/701/702: 878 SRM 909b c 01/11: 678 c 02/701/702: 8678 SRM 927d c 01/11: 679 c 02/701/702: 8679 SRM 927d c 01/11: 700 c 02/701/702: 8700

9 cobas c 01 / c 02 / c 11 / c 701 / c C.f.a.s. Cat. No UIBC Unsaturated iron-binding capacity FerroZine cobas c 01, c 02, c 11 UREAL Urea Urease/GLDH UREAL Urea Urease/GLDH 1 through iron c 01/11: 78 c 02: 878 c 01/11: 18 c 02/701/702: 818 c 01/11: 19 c 02/701/702: µg/dl This uncertainty (expanded uncertainty; k = 2) was calculated in accordance with the Guide to the expression of uncertainty in (GUM: 199). For the estimation of the single standard uncertainties normal distribution of the results is assumed; the level of confidence of the expanded uncertainty is about 9% with the coverage factor k=2 (analogue to the 2sd of the standard uncertainty). 2 CRM = Certified, European SRM = Standard = Isotope dilution mass spectrometry IFCC = International Federation of clinical chemistry and laboratory medicine 6 ERM = European s 7 Unless otherwise noted, the assigned values and uncertainties are valid for cobas c 01, cobas c 02, cobas c 11, cobas c 701 and cobas c 702 provided that the method is available on that analyzer. 8 The value describes the uncertainty within a system class. By transferring the setpoint from one system class to another an additional systematic deviation can arise. This deviation is limited by the instrument to instrument specification. The relative maximum deviation is %, resp. 10 U/l CK2. 9 The value describes the uncertainty within a system class. By transferring the setpoint from one system class to another an additional systematic deviation can arise. This deviation is limited by the instrument to instrument specification. The relative maximum deviation is %, resp. 0,1 mmol/l Chol (IDMS).

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