依据室内质控和室间质评数据评定ELISA检测测量不确定度

Evaluation of the uncertainty of ELISA tests using internal quality control and external quality assessment

目的评价Nordtest准则在酶联免疫吸附试验（ELISA）检测测量不确定度评定中的适用性。方法收集检验科2013年6～11月共215次（HBsAg）和210（HIV）次室内质控数据和2010—2013年卫计委临床检验中心室间质评结果。依据Nordtest准则评估乙肝表面抗原（HBsAg）和HIV抗原／抗体（HIVAg／Ab）检测方法的合成不确定度和扩展不确定度。结果取95％的置信区间，包含因子k=2，HBsAg和HIV扩展不确定度分别为UHBV=47．02％和UHIV=44．62％。结论Nordtest准则结合室内质控和临检中心室间质评回报数据，来评价ELISA检测测量不确定度适用于目前血站实验室实际情况。

Objective To evaluate the suitability according to Nordtest guideline for estimating the uncertainty of ELISA tests in blood screening laboratory. Methods 215 HBsAg and 210 HIV Internal Quality Controls （IQCs） testing results from Huzhou Central Blood Bank from July to December 2013 and 8 External Quality Assessments＇ （EQAs） data organized by NCCL from 2010 to 2013 were collected. The combined and expanded uncertainties of HBsAg and HIV were evaluated according to the Nordtest guideline. Results The expanded uncertainty of HBsAg and HIV testing were 47.02% and 44. 62% , respectively, with a 95% confidence interval, and contains factor k = 2. Conclusion The Nordtest guideline is suitable to evaluate the measurement uncertainty of blood screening laboratory.