利用不确定度对ELISA检测灰区设置的探讨

Discussion of gray zone setting by application of uncertainty in ELISA test

目的:通过对ELISA检测项目临界值不确定度评定,探讨适合血站的ELISA检测项目的灰区设定方法。方法:依据中国合格评定国家认可委员会(CNAS)《测量不确定度要求的实施指南》及JJF1059-1999《测量不确定度评定与表示》等其他不确定度指南文件,采用A、B类评定方法对实验室酶免检测临界值的测量不确定度进行评定。结果:在C.O取0.15时,临界值的不确定度为0.150±0.033,为临界值的22%。结论:本实验所使用的方法可以对酶免检测临界值的测量不确定度进行评定。

Objective：To evaluate the cutoff value using uncertainty in ELISA test,and explore the method of setting gray zone for ELISA in the blood screening laboratory.Method：According to ＂ Guidance on the Application of the Requirements for Measurement Uncertainty＂ issued by China National Accreditation Service for Conformity Assessment（CNAS）,JJF1059-1999 ＂ Evaluation and Expression of Uncertainty in Measurement＂,and other related regulation for uncertainty measurement,type A and B assessment method were applied to evaluate the measurement uncertainty of the cutoff value in ELISA test.Result：When the C.O value was 0.15,uncertainty was 0.150±0.033,which was 22% of the cutoff value.Conclusion：The method used here could be applied to evaluate the uncertainty of cutoff value in ELISA test.