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《Chinese Journal of Blood Transfusion》 2014-04
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Applicability of CLSI EP12-A2 used in performance validation of ELISA in detection laboratory in blood bank

ZHANG Jing;YU Lei;WANG Rui;GE Hongwei;Beijing Blood Center;  
Objective To evaluate the applicability of EP12-A2 document protocols issued by United States of America Clinical Laboratory Standards Institute(CLSI) in the performance qualification of ELISA method in the blood screening laboratory.Methods According to the released CLSI EP12-A2 document protocols,all qualitative tests used at present were made performance validation,including research on the reproducibility for four assays and comparison for eight assays with each other.Results the reproducibility study:The sample with C50 concentration for HBsAg B assay and anti-HCV B assay was screen out successfully.For both assays,the cutoff(C50) + 20% concentrations of samples produced positive results count ≥ 95%,and the cutoff(C50)-20% concentrations of the samples produced negative results count ≥ 95%.Anti-TP B assay and anti-HCV A assay were unable to find the sample with C50 concentration due to fixed cutoff,so it couldn't obtain reproducible results.The comparison study:Using samples with known clinical diagnosis result,sensitivity and specificity of 8 ELISA assays were high.There were no significant differences in sensitivity and specificity between the two kind of HBsAg assay(1 group),and the same as anti-HCV,anti-HIV,anti-TP.Conclusion It demonstrated that in the study of reproducibility study of 4 ELISA assays and 8 ELISA assays of performance validation study,part of the assays were not suitable for EP12-A2 reproducible research method for precision assessment because of the cutoff setting means in blood screening laboratory.The protocols used in assay performance comparison in EP12-A2 documents were applied in all qualitative tests performance validation.
【Fund】: 卫生部卫生公益性行业科研专项资助项目(200902008)
【CateGory Index】: R446.6
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