罗氏电化学发光校准品溯源性与不确定度V201501.docVIP

Roche Professional Diagnostics Penzberg, 21.Jan. 2015 Standardization and Quality Control Penzberg Page PAGE 1 of NUMPAGES 19 Elecsys? CalSet Traceability And Uncertainty Version 44 1 The uncertainty (expanded uncertainty; k = 2) was calculated in accordance with the “Guide to the expression of uncertainty in measurement” (GUM:1993). Routine Method Elecsys? Systems Immunoassay THYROID Reference Method Reference Material Selected Measurement Procedure Calibrator Value Uncertainty 1 Unit Anti-TG CalSetInternational Standard (NIBSC) 65/93 Cal. 1: 37.7Cal. 2: 3200 4.9176 kIU/L Anti-TPO CalSet International Standard (NIBSC) 66/387 Cal. 1: 35Cal. 2: 378 1.410.1 kIU/L Calcitonin CalSetWHO 2nd IRP 89/620 Cal. 1: 2.11Cal. 2: 489 0.0934.85 pg/ml FT3 CalSetEquilibrium dialysis Cal. 1: 2.18Cal. 2: 40.6 0.160.73 pmol/L FT3 III CalSetInhouse reference system (FT3 Cal. 1: 2.43 Cal. 2: 39.1 0.083 0.586 pmol/l FT4 CalSetInhouse reference system(commercially available FT4 enzyme-immunoassay) Cal. 1: 10 Cal. 2: 45 0.28 1.38 pmol/L FT4 II CalSetInhouse reference system (FT4 Cal. 1: 10Cal. 2: 46.9 0.1340.591 pmol/l T3 CalSetGravimetry Cal. 1: 1.3Cal. 2: 8.49 0.04 0.35 nmol/L T4 CalSetID-GC/MS (Isotope dilution gas chromatography/mass spectrometry Cal. 1: 51.5Cal. 2: 232 3.11 12.5 nmol/L T-uptake CalSetReference Sera Pools with value of 0 and 1 Cal. 1: 0.37Cal. 2: 1.31 0.07 0.02 TBI Routine Method Elecsys? Systems Immunoassay THYROID Reference Method Reference Material Selected Measurement Procedure Calibrator Value Uncertainty 1 Unit TSH CalSet WHO 2nd IRP (80/558) Cal. 1: 0Cal. 2: 1.71 0.00 0.02 mIU/L TG CalSetCertified Reference Material (CRM), 457 (Community Bureau of Reference) Cal. 1: 4.24Cal. 2: 858 0.12 14.1 μg/L TG II CalSetBCR Reference Material No. 457 Human Thyroglobulin Cal. 1: 0.254C