TRACEABILITY and UNCERTAINTY 7

Transcription

1 Routine Method COBAS INTEGRA systems Acid phosphatase total 1-naphthyl phosphate Integra 00 plus Acid phosphatase total 1-naphthyl phosphate Acid phosphatase, non-prostatic Integra 00 plus Acid phosphatase, non-prostatic Acid phosphatase, prostatic Integra 00 plus Acid phosphatase, prostatic ALB2 Albumin BCG Test-ID / ACN Selected Measurement Procedure Assigned Value Uncertainty calculated calculated g/dl g/l 0-92 c 111: 1 Reference Method Reference Material ERM-DA70k/IFCC 6 1 Unit

2 IFCC IFCC IFCC primary tube IFCC primary tube IFCC IFCC IFCC primary tube IFCC primary tube ALTL Alanine aminotransferase IFCC with pyridoxal phosphate ALTL Alanine aminotransferase IFCC without pyridoxal phosphate AMYL2 Amylase alpha IFCC EPS ver. 2 AMYL2 Amylase alpha IFCC EPS ver. 2 urine c 111: c 111: (Tietz, 198), manual (Schumann, 1), manual (Tietz, 198), manual (Schumann, 1), manual (Tietz, 198), manual (Schumann, 1), manual (Tietz, 198), manual (Schumann, 1), manual 0-9 c 111: 68 (2002), manual 0-9 c 111: 68 (2002) modified, manual c 111: Roche reagent according to IFCC (1998), manual Roche reagent according to IFCC (1998), manual

3 AMY-P Amylase pancreatic alpha EPS liquid AMY-P Amylase pancreatic alpha EPS liquid urine ASTL Aspartate aminotransferase IFCC with pyridoxal phosphate ASTL Aspartate aminotransferase IFCC without pyridoxal phosphate BIL-D Diazo Integra 00 plus BIL-D Diazo BIL-D Diazo verdünnt 1+2 BILD2 Diazo BILD2 Doumas BILT Bilirubin total Gen. DPD BUN Blood urea nitrogen Urease/GLDH c 111: c 111: 686 (2002), manual 0-9 c 111: 687 (2002) modified, manual 0-29 c 111: (JendrassikGrof) (Doumas method) 0-7 c 111: c 111: c 111: 712 acc. to Doumas c 111:

4 CA2 Calcium nm-bapta CHE2 Cholinesterase butyrylthiocholine CHED2 Cholinesterase/Dibucaine butyrylthiocholine CHOL2 Cholesterol CHOD-PAP stand. ID/MS CHOL2 Cholesterol CHOD-PAP stand. AbellKendall CKL Creatine kinase IFCC liquid CK2 Creatine Kinase UV acc. to IFCC liquid Integra 00, cobas c 111 CREP2 Creatinine plus ver. 2 CREJ2 Creatinine Jaffé compensated Integra 00 plus CREJ2 Creatinine Jaffé compensated GGT-2 Glutamyltransferase gamma liquid ver. 2 stand. Szasz 0-02 c 111: 698 SRM 96c L c 111: c 111: Abell-Kendall 0-2 c 111: 7 (2002), manual I 00: 0-0 c 111: 0 (2002), manual c 111: c 111: c 111: c 111: 80 Original formulation Persijn/v.d. Slik (1976), manual

5 GGT-2 Glutamyltransferase gamma liquid ver. 2 stand. IFCC GLDH Glutamate dehydrogenase opt. (DGKC) Gen. HK serum, plasma HK CSF HK urine HK hemolysate HK Gen. serum, plasma HK Gen. serum, plasma STAT HK Gen. CSF HK Gen. CSF STAT HK Gen. urine HK Gen. urine STAT 0-98 c 111: 220 (2002), manual c 111: c 111:

6 HBDH2 Hydroxybutyrate dehydrogenase alpha opt. (DGKC) IRON2 Iron FerroZine LACT2 Lactate enzymatic colorimetric test LACT2 Lactate enzymatic colorimetric test CSF LDHI2 IFCC liquid ver. 2 LDHI2 IFCC liquid ver. 2 primary tube LDHL opt. (DGKC) LDHL opt. (DGKC) primary tube LIPC Lipase enzymatic colorimetric test MG Magnesium Chlorophosphonazo III PHOS2 Phosphate (inorganic) molybdate UV ver. 2 TRIGL Triglycerides GPO-PAP µg/dl 0-96 c 111: 661 SRM c 111: 0 Primary reference material (weighed in purified material) Primary reference material (weighed in purified material) c 111: 80 (2002), manual 0-07 (2002), manual c 111: c 111: 69 Atomic absorption Primary reference material (NERL) (weighed in purified material) 0-61 c 111: c 111: 781

7 1 TP2 Total protein Biuret TP2 Total protein Biuret monochromatic UA2 Uric acid enzymatic colorimetric test ver. 2 UREAL Urea/BUN Urease/GLDH SRM 927d c 111: 227 SRM 927d 0-61 c 111: c 111: g/dl g/l g/dl g/l 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 Reference Material, European SRM = Standard Reference Material = Isotope Dilution - Mass Spectrometry IFCC = International Federationof clinical chemistry and laboratory medicine 6 ERM = European Reference Materials 7 Unless otherwise noted, the assigned values and uncertainties are valid for Integra and cobas c 111 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. CK2 10.