2Clinical and Laboratory Standards Institute. Evaluation of precision performance of quantitative measurement methods. Wayne, Pennsylvania: EP5-A2,CLSJ,2004.14-20.
4Clinical and Laboratory Standards Institute. User demonstration of performance for precision and accuracy. Wayne, Pennsylvania: EP15-A2, CLSI ,2004.
5National Committee for Clinical Laboratory Standards. Preliminary evaluation of quantitative clinical laboratory methods, approved guideline. 2nded. Wayne, PA EPIO-A2, NCCLS,2002.
6Clinical and Laboratory Standards Institute. Evaluation of the linearity of quantitative measurement procedures . Wayne, Pennsylvania: EP6-A2,CLSI,2003 ,10-14.
7Jiang JS, Chang CC, Fink DJ, et al. Evaluation of linearity in the clinical Laboratory. Arch PathOI Lab Med ,2004,128: 44.
2U. S. Department of Health and Human Services, Centers for Medicare&Medicaid Services. Clinical laboratory improvement amendments of 1988 :final rule [ S]. Fed Register,2003:3704.
4CLSI. EP5-A. Evaluation of precision performance of clinical chemistry devices [ S]. 1999 : 1-28.
5CLSI. EP6-A2. Evaluation of the linearity of quantative analytical methods [ S ]. 2003 : 1-47.
6CLSI. C28-A2. How to define and determine reference intervals in the clinical laboratory [ S ]. 2000 : 1-31.
7CLSI. EP17-A. Protocols for determination of limits of detection and limits of quanitation [ S]. 2004 : 1-39.
8CLSI. EP7-A2. Interference testing in clinical chemistry[ S]. 2005: 1-47.
9Broughton P,Gowenlock A,McCormack J,et al. A revised scheme for the evaluation of automatic instruments for use in clinical chemistry [ J ]. Ann Clin Biochem,2007,11 ( 6 ) : 207-218.
10CLSI. EP15-A. User demonstration of performance for precision and accuracy [ S]. 2001 : 1-15.
