1U.S. Department of Health and Human Services. 42 CFR Part 493: medicare, medicaid and CLIA programs;Laboratory requirements relating to quality systems and certain personnel qualifications; Final rule[ J ]. Federal Register, 2003,68:3640-3714.
2Jan SK. Evaluation of assay systems [ J ]. Clin Lab News,2001,27 : 10-14.
3Laessig RH, Ehrmeyer SS, Leinweber JE. Intralaboratory performance requirements necessary to pass proficiency testing: CAP-1990 vs CLIA-1967 ( March 14,1990) formats compared [ J ]. Clin Chem, 1992,38 :895-903.
4U.S. Department of Health and Human Services.Medical devices;Current good manufacturing practice(CGMP) final rule :quality system regulation. 21 CFRParts 808,812 and 820 [ J ]. Federal Register, 1996,61 : 52602-52662.
5National Committee for Clinical Laboratory Standards.Evaluation of precision performance of clinical chemistry devices, approved guideline [ S ]. Wayne, PA:EPSoA. NCCLS. 1999.
6U.S. Department of Health and Human Services.Medicare,medicaid and CLIA programs; Regulationsimplementing the clinical laboratory improvement amendments of 1998 (CLIA). Final rule [ J ]. Fed Regist, 1992,57:7002-7186.
7VITROS system verification [ S ]. Ortho-Clinical Diagnotics, USA ,2004.
8National Committee for Clinical Laboratory Standards.User demonstration of performance for precision and accuracy [ S ]. Wayne, PA : EP15-P. NCCLS. 1998.
9National Committee for Clinical Laboratory Standards.Method comparison and bias estimation using patientsamples, approved guideline [ S ].2nd ed. Wayne, PA :EP9-A2. NCCLS. 2002.
10National Committee for Clinical Laboratory Standards.Evaluation of the linearity of quantitative measurement procedures : a statistical approach, approved guideline[S]. Wayne,PA:EP6-A. NCCLS. 2003.