[1] §493.1253 Standard: establishment and verification of performance specifications[EB/OL]. (2003-08-22)[2014-06-05]http://www.gpo.gov/fdsys/pkg/CFR-2003-title42-vol3/xml/CFR-2003-title42-vol3-part493.xml#seqnum493.1253.
[2] Joint Committee for Guides in Metrology. International vocabulary of metrology-Basic and general concepts and associated terms (VIM) [S].3rd edition. JCGM 200:2012(E/F), JCGM, 2012.
[3] National Committee for Clinical Laboratory Standards. Evaluation of precision performance of quantitative measurement methods[S]. EP05-A2,NCCLS,2004.
[4] Clinical and Laboratory Standard Institute. User verification of performance for precision and trueness[S]. EP15-A2, CLSI, 2005.
[5] 金丕焕,陈 峰. 医用统计方法 [M]. 第3版.上海:复旦大学出版社,2009: 1-761.
[6] Netrella MG. 实验统计学 [M]. 毛镇道,蒋子刚,译. 上海:上海翻译出版公司, 1990: 351-356.
[7] National Committee for Clinical Laboratory Standards. Proposed guideline for user evaluation of performance of clinical chemistry devices[S]. EP05-P, NCCLS,1982.
[8] National Committee for Clinical Laboratory Standards. Method comparison and bias estimation using patient samples[S]. EP9-A2, NCCLS, 2002.
[9] National Committee for Clinical Laboratory Standards. Evaluation of the linearity of quantitative measurement procedures; a statistical approach[S]. EP6-A, NCCLS, 2003.
[10] Clinical and Laboratory Standard Institute. Evaluation of matrix effects[S]. EP14-A2, CLSI, 2005.
[11] National Committee for Clinical Laboratory Standards. Protocols for determination of limits of detection and limits of quantitative[S]. EP17-A, NCCLS, 2004.
[12] Westgard JO, de Vos DJ, Hunt MR, et al. Concepts and practices in the evaluation of clinical chemistry methods. Ⅲ: statistics[J]. Am J Med Technol, 1978, 44(6):552-571.
[13] Sheskin DJ. Handbook of parametric and nonparametric statistical procedures[M]. 3rd Edition. New York: Chapman & Hall/CRC, 2003:1-1193. |