中国输血杂志2018，Vol.31Issue(6)：663-665,3.DOI:10.13303/j.cjbt.issn.1004-549x.2018.06.026
血站实验室HBsAg检验方法和程序分析性能验证与比对
Investigation of the HBsAg detection methods and their corresponding analytical procedure performance in blood center labs
摘要
Abstract
Objective To investigate the HBs Ag detection methods and their corresponding analytical procedure performance in blood center labs. Methods HBs Ag confirmation test was performed by automatic ELISA machine for all the detection protocols to evaluate performances. The methods and parameters in this study includes: 1) evaluate the test precision between intra-analysis and inter-analysis by comparing the repeated test results within group and the quality control data between groups; 2) utilizing the results from standard serum plate to confirm the consistency of test results; 3) confirm the detection limit using sample within the lab with known concentration and with series dilution; 4) utilizing 100 HBs Ag negative serum samples and 100 HBs Ag positive samples to calculate the percentage of samples with cut-off value of 0. 8 and 1. 2 within total sample to confirm the repeatability of the cut-off value; 5) conduct the comparison for ELISA machine and the operator using 10 HBs Ag negative and 10 HBs Ag positive samples. Results 1) The precision of the test result for intra-analysis and inter-analysis are 3. 92％ and 14. 36％; 2) the consistency with standard serum plate is 100％; 3) the detection limit for HBs Ag is 0. 02 IU/ml; 4) the percentage of samples with the cut-off ratio of 0. 8 and 1. 2 is ≤5％ of total sample, which passed the test; 5) the consistency of ELISA machine and the operator is 100％. Conclusion The HBs Ag detection method and its analytical performance meet the requirement of ELISA kit. And the comparison for the machine and the operator meets the requirement of the test.关键词
ELISA/HBsAg/性能验证/比对Key words
ELISA/HBsAg/functional test/comparison分类
医药卫生引用本文复制引用
王霞,潘彤,刘军,杨文玲..血站实验室HBsAg检验方法和程序分析性能验证与比对[J].中国输血杂志,2018,31(6):663-665,3.
