羅氏電化學(xué)發(fā)光校準(zhǔn)品溯源性與不確定

1、Roche Professional DiagnosticsPenzberg, 21.Jan. 2015Standardization and Quality Control PenzbergPage Elecsys CalSetTraceability And UncertaintyVersion 441The uncertainty (expanded uncertainty; k = 2) was calculated in accordance with the “Guide to the expression of uncertainty in measurement” (GUM:1

2、993).Routine MethodElecsys Systems Immunoassay THYROIDReference MethodReference MaterialSelected Measurement ProcedureCalibrator ValueUncertainty 1UnitAnti-TG CalSet06368603International Standard (NIBSC) 65/93Cal. 1: 37.7Cal. 2: 32004.9176kIU/LAnti-TPO CalSet 06472931International Standard (NIBSC) 6

3、6/387Cal. 1: 35Cal. 2: 3781.410.1kIU/LCalcitonin CalSet06445861WHO 2nd IRP 89/620Cal. 1: 2.11Cal. 2: 4890.0934.85pg/mlFT3 CalSet03051994Equilibrium dialysisCal. 1: 2.18Cal. 2: 40.60.160.73pmol/LFT3 III CalSet06437290Inhouse reference system (FT3 03051986) Cal. 1: 2.43Cal. 2: 39.10.0830.586pmol/lFT4

4、CalSet11731661Inhouse reference system(commercially available FT4 enzyme-immunoassay)Cal. 1: 10 Cal. 2: 45 0.28 1.38 pmol/LFT4 II CalSet06437290Inhouse reference system (FT4 11731297)Cal. 1: 10Cal. 2: 46.90.1340.591pmol/lT3 CalSet11731548GravimetryCal. 1: 1.3Cal. 2: 8.49 0.04 0.35 nmol/LT4 CalSet120

5、17717ID-GC/MS (Isotope dilution gas chromatography/mass spectrometryCal. 1: 51.5Cal. 2: 232 3.11 12.5 nmol/LT-uptake CalSet11731505Reference Sera Pools with value of 0 and 1Cal. 1: 0.37Cal. 2: 1.310.07 0.02 TBIRoutine MethodElecsys Systems Immunoassay THYROIDReference MethodReference MaterialSelecte

6、d Measurement ProcedureCalibrator ValueUncertainty 1UnitTSH CalSet 04738551WHO 2nd IRP (80/558)Cal. 1: 0Cal. 2: 1.710.00 0.02mIU/LTG CalSet11820940Certified Reference Material (CRM), 457 (Community Bureau of Reference)Cal. 1: 4.24Cal. 2: 8580.12 14.1 g/LTG II CalSet06445900BCR Reference Material No.

7、 457 Human ThyroglobulinCal. 1: 0.254Cal. 2: 1700.0111.605ng/mla-TSHR CalSet04388780International Standard (NIBSC) 90/672Cal. 1: 0.63Cal. 2: 25.30.11 0.33 IU/LRoutine MethodElecsys Systems Immunoassay CARDIACReference MethodReference MaterialSelected Measurement ProcedureCalibrator Value Uncertainty

8、 1UnitCK-MB STAT CalSet11731572Inhouse reference system (microparticle immunoassay, commercially available CK-MB test)Cal. 1: 1.53Cal. 2: 24.50.101.23g/LCK-MB CalSet11821601Inhouse reference system (Elecsys CK-MB STAT)Cal. 1: 1.62Cal. 2: 25.00.091.14g/LCK-MB STAT CalSet05957656Inhouse reference syst

9、em (microparticle immunoassay, commercially available CK-MB test)Cal. 1: 1.50Cal. 2: 25.20.050.58g/LCK-MB CalSet05957664Inhouse reference system (Elecsys CK-MB STAT)Cal. 1: 1.53Cal. 2: 24.00.050.48g/LDigitoxin CalSet03002667GravimetryCal. 1: 5.32Cal. 2: 64.20.130.66g/LDigoxin CalSet11820907Gravimetr

10、yCal. 1: 0.53Cal. 2: 3.680.03 0.09 g/LGDF-15 CalSet07125941GravimetryCal. 1: 398Cal. 2: 130005.839134.74 pg/mLMyoglobin STATCalSet11820893Inhouse reference materialCal. 1: 28.5Cal. 2: 12400.74 46.46 g/LMyoglobin CalSet12178222Inhouse reference system(Elecsys Myoglobin STAT)Cal. 1: 27.0Cal. 2: 11700.

11、40 51.00 g/LRoutine MethodElecsys Systems Immunoassay CARDIACReference MethodReference MaterialSelected Measurement ProcedureCalibrator Value Uncertainty 1UnitTroponin T CalSet04856627(fr RP TnT 4.Gen 04491815)Inhouse reference system (Elecsys Troponin T STAT 4.Gen)Cal. 1: 0.078Cal. 2: 10.30.0010.20

12、 g/LTroponin T STAT CalSet 04856643 (fr RP TnT 4.Gen STAT 04660307)Inhouse reference system (Elecsys Troponin T STAT 3.Gen)Cal. 1: 0.078Cal. 2: 10.10.0020.103 g/LRoutine MethodElecsys Systems Immunoassay CARDIACReference MethodReference MaterialSelected Measurement ProcedureCalibrator Value Uncertai

13、nty 1UnitproBNP CalSet03121658GravimetryCal. 1: 136Cal. 2: 26903.24 22.2 ng/LproBNP II CalSet04842472inhouse reference system (Elecsys proBNP 1.GEN)Cal. 1: 140Cal. 2: 27181.8938.0ng/LproBNP II STAT CalSet05390109inhouse reference system (Elecsys proBNP IICal. 1: 140Cal. 2: 28002.1529.9ng/LTroponin T

14、 hs CalSet05092752(fr RP TnT hs 05092744)Inhouse reference system (Elecsys Troponin T STAT 4.Gen)Cal. 1: 19.5Cal. 2: 479010.657.5ng/LTroponin T hs STAT CalSet 05092736(fr RP TnT hs STAT 05092728)Inhouse reference system (Elecsys Troponin T hs)Cal. 1: 17.7Cal. 2: 41009.7555.4 ng/LTroponin I CalSet050

15、94828Inhouse reference system (commercially available Troponin I test)Cal. 1: 0.36Cal. 2: 280.0140.401g/LTroponin I STAT CalSet05094801Inhouse reference system (Elecsys Troponin I)Cal. 1: 0.46Cal. 2: 32.20.0180.415g/LRoutine MethodElecsys Systems Immunoassay TUMOR MARKERReference MethodReference Mat

16、erialSelected Measurement ProcedureCalibrator Value Uncertainty 1UnitAFP CalSet Gen.2.1044877611st IRP WHO Reference Standard 72/225Cal. 1: 4.55Cal. 2: 49.21.55 2.24kIU/LCA 125 II CalSet11776240Inhouse reference system(commercially available CA125 radiobinding immunoassay)Cal. 1: 33.5Cal. 2: 5041.74

17、13.76kIU/LCA 125 Gen2 CalSet07030207Inhouse reference system(commercially available CA125 radiobinding immunoassay)Cal. 1: 0Cal. 2: 5122.657.32kIU/LCA 15-3 CalSet03045846Inhouse reference system(commercially available CA153 radiobinding immunoassay)Cal. 1: 13.8Cal. 2: 93.40.822.37kIU/LCA 19-9 CalSet

18、11776215Inhouse reference system(commercially available CA199 radiobinding immunoassay) Cal. 1: 21.2Cal. 2: 2503.256.55kIU/LCA 72-4 CalSet11776274Inhouse reference system(commercially available CA724 radiobinding immunoassay)Cal. 1: 0.93Cal. 2: 69.20.242.68kIU/LCEA CalSet117316451st IRP WHO Referenc

19、e Standard 73/601Cal. 1: 4.33Cal. 2: 48.70.111.33g/LCyfra 21-1 CalSet11820974Inhouse reference system(commercially available Cyfra 21-1 enzyme-immunoassay)Cal. 1: 0.00Cal. 2: 44.70.100.64g/Lfree PSA CalSet03289796WHO 96/668(100% freePSA)Cal. 1: 0.17Cal. 2: 34.60.01 0.41g/LHE4 CalSet 05950945HE4 Fuji

20、rebio MTPCal. 1: 4.66Cal. 2: 2051.35 12.6pmol/LRoutine MethodElecsys Systems Immunoassay TUMOR MARKERReference MethodReference MaterialSelected Measurement ProcedureCalibrator Value Uncertainty 1UnitNSE CalSet12133121Inhouse reference system(commercially available NSE enzyme-immunoassay) Cal. 1: 0.3

21、0Cal. 2: 33.40.03 0.47 g/LPAPP-A CalSet04854101Kryptor PAPP-A (BRAHMS)Cal. 1: 82.0Cal. 2: 25002.9398.09mU/LproGRP CalSet06505970Inhouse reference system(commercially available proGRP immunoassay)Cal. 1: 13.2Cal. 2: 2323.5413.776pg/mlS100 CalSet03289843Fa. Affinity S100 antigen lot. no. Z03833Cal. 1:

22、 0.045Cal. 2: 1.770.000.02g/LSCC CalSet07126999Abbott Architect SCCCal. 1: 1.24Cal. 2: 22.50.1050.238ng/mLtotal PSA CalSet II04485220WHO 96/670 (90% PSA-ACT+10% free PSA)Cal. 1: 0.000Cal. 2: 57.30.14 1.29 g/LRoutine MethodElecsys Systems Immunoassay FERTILITYReference MethodReference MaterialSelecte

23、d Measurement ProcedureCalibrator Value Uncertainty 1UnitAMHCalSet06331084Beckmann Coulter AMH GIICal. 1: 0.025Cal. 2: 9.240.0020.363ng/mLDHEA-S CalSet03000095GravimetryCal. 1: 0.14Cal. 2: 19.50.021.0mol/LEstradiol II CalSet 03064921ID-GC/MS (Isotope dilution gas chromatography/mass spectrometry)Cal

24、. 1: 55Cal. 2: 99094.0 198pmol/LEstradiol Gen3 CalSet06656048ID-GC/MS (Isotope dilution gas chromatography/mass spectrometry)Cal. 1: 23.9Cal. 2: 19504.23 67.186pg/mLFSH CalSet II030326802nd IRP WHO 78/549Cal. 1: 0.89Cal. 2: 52.20.13 1.4 IU/LLH CalSet II 035610972nd International Standard (NIBSC) 80/

25、552Cal. 1: 0.86 Cal. 2: 470.06 1.5 IU/LProgesterone CalSet12145391ID-GC/MS (Isotope dilution gas chromatography/mass spectrometry)Cal. 1: 0.3Cal. 2: 1620.13 6.36nmol/LProgesterone III CalSet07092547ID-GC/MS (Isotope dilution gas chromatography/mass spectrometry)Cal. 1: 0.015Cal. 2: 51.10.0172.076ng/

26、mlRoutine MethodElecsys Systems Immunoassay FERTILITYReference MethodReference MaterialSelected Measurement ProcedureCalibrator Value Uncertainty 1UnitProlactin II CalSet03277356WHO 3rd IRP 84/500Cal. 1: 0,075Cal. 2: 21000.04 37,2 mIU/LTestosterone IICalSet05202230ID-GC/MS (Isotope dilution gas chro

27、matography/mass spectrometry)Cal. 1: 1.46Cal. 2: 36.10.07 1.10nmol/LPLGF CalSet05144701Inhouse reference system(commercially available PLGF microtiterplate immunoassay)Cal. 1: 2.85Cal. 2: 10400.4015.2ng/LsFlt-1 CalSet05109531Inhouse reference system(commercially available sFlt-1 microtiterplate immu

28、noassay)Cal. 1: 0Cal. 2: 151000.00227ng/LRoutine MethodElecsys Systems Immunoassay FERTILITYReference MethodReference MaterialSelected Measurement ProcedureCalibrator Value Uncertainty 1UnithCG STAT CalSet033030714th Standard 1999 (NIBSC), coded 75/589Cal. 1: 9.97Cal. 2: 49000.1849.09 IU/LhCG+ CalSe

29、t033026524th Standard 1999 (NIBSC), coded 75/589Cal. 1: 1.65Cal. 2: 19200.1326.98 IU/Lfree hCG beta CalSet04854080International Reference Preparation of Chorionic Gonadotrophin Beta Subunit, human, for immunoassay (NIBSC), coded 75/551Cal. 1: 0.94Cal. 2: 60.30.0160.775 IU/LSHBG CalSet03052028NIBSC 1

30、st International Standard 95/560Cal. 1: 0.22Cal. 2: 37.00.031.56nmol/LRoutine MethodElecsys Systems Immunoassay ANEMIAReference MethodReference MaterialSelected Measurement ProcedureCalibrator Value Uncertainty 1UnitFerritin CalSet03737586NIBSC Standard #80/602Cal. 1: 9.92Cal. 2: 2931.18 7.68 g/LFol

31、ate III CalSet04874072Elecsys Folat IICal. 1: 1.23Cal. 2: 16.10.140.31g/LFolate III CalSet04874072WHO IS 03/178Cal. 1: 1.39Cal. 2: 16.00.300.66g/LFolate RBC CS05944309Elecsys Folat IIICal. 1: 48.2Cal. 2: 54028.975.8g/LVitamin B12 CalSet II 04572459Inhouse reference systemElecsys B12 ICal 1: 216Cal 2

32、: 15902.7818.3ng/LVitamin B12 IICalSet07212780Inhouse reference systemElecsys B12 Gen2Cal 1: 239Cal 2: 142012.336.4ng/LRoutine MethodElecsys Systems Immunoassay BONEReference MethodReference MaterialSelected Measurement ProcedureCalibrator Value Uncertainty 1Unit-CrossLaps CalSet11972316Gravimetry(i

33、nhouse reference material)Cal. 1: 50Cal. 2: 20000.01 0.05 ng/LN-MID Osteocalcin CalSet11972111Inhouse reference system(commercially available osteocalcin enzyme-immunoassay/ radiobinding assay)Cal. 1: 0Cal. 2: 2800.05 6.36 g/LPTH CalSet11972219Inhouse reference system(commercially available PTH radi

34、obinding assay)Cal. 1: 0Cal. 2: 44000.07 85.74 ng/LPTH stat CalSet04894138Inhouse reference system(commercially available PTH radiobinding assay)Cal. 1: 0.86Cal. 2: 40202.63100ng/LPTH 1-84 CalSet05608554NIBSC 95/646Cal. 1: 2.49Cal. 2: 4000.1387.366ng/LP1NP CalSet03141080Gravimetry(inhouse reference

35、material)Cal. 1: 21.8Cal. 2: 8260.7723.78g/LhGH CalSet05390133NIBCS/WHO 98/574 in hGH free human serumCal. 1: 0Cal. 2: 9950081.95ng/LRoutine MethodElecsys Systems Immunoassay BONEReference MethodReference MaterialSelected Measurement ProcedureCalibrator Value Uncertainty 1UnitVitamin D total CalSet0

36、5894921NIST-StandardCal. 1: 1.22Cal. 2: 42.80.302.31ng/mLVitamin D total CalSet for US06506798NIST-StandardCal. 1: 1.94Cal. 2: 36.10.460.87ng/mLRoutine MethodElecsys Systems Immunoassay SEPSISReference MethodReference MaterialSelected Measurement ProcedureCalibrator Value Uncertainty 1UnitIL-6 CalSe

37、t051094691st International Standard (NIBSC) 89/548Cal. 1: 16.0Cal. 2: 6250.302.91ng/LPCT CalSet05056888PCT BRAHMS LIACal. 1: 0.10Cal. 2: 52.6 0.044.75g/LRoutine MethodElecsys Systems Immunoassay RAReference MethodReference MaterialSelected Measurement ProcedureCalibrator Value Uncertainty 1Unita-CCP

38、 CalSet05031656Eurodiagnostica Immunoscan RACal. 1: 18.3Cal. 2: 194 0.431.68kU/LRoutine MethodElecsys Systems Immunoassay INFECTIOUS DISEASESReference MethodReference MaterialSelected Measurement ProcedureCalibrator Value Uncertainty 1UnitAnti-HAV CalSet0485497705524261Second International Standard

39、for Anti-Hepatitis A, Immunoglobulin, Human, NIBSC code: 97/646Cal. 1: 9.76Cal. 2: 48.10.340.62IU/LAnti-HBs CalSet118205241st WHO Reference Standard 1977Cal. 1: 10.9Cal. 2: 5170.59.1IU/LAnti-HBs II CalSet058948161st WHO Reference Standard 1977In house reference system (Anti HBs)Cal. 1: 6.58Cal. 2: 3

40、970.134.82IU/LHBsAg II quant05957435HBsAg subtype adw2NIBSC 00/588Cal. 1: 0Cal 2: 0.520.0020.021IU/mLHBsAg II quant II07143737HBsAg subtype adw2NIBSC 00/588In house reference system (HBsAg II quant)Cal. 1: 0Cal 2: 46.80.0023.174IU/mLRoutine MethodElecsys Systems Immunoassay OTHERSReference MethodReference MaterialSelected Measurement ProcedureCalibrator Value Uncertainty 1UnitCortisol CalSet11875124 ID-GC/MS (Isotope dilution gas chromatography/mass spectrometry