ELISA法HBsAg检测试剂盒质量评价

The quality evaluation of the various HBsAg ELISA kits

目的比较国产ELISA法HBsAg检测试剂盒的质量差异,优选适宜于献血者HBsAg检测的试剂盒。方法应用HBsAg国家参考品对所购进的试剂盒进行质量评价。结果5个厂家试剂的阴性符合率、阳性符合率、总符合率、灵敏度和精密度存有一定差别,2个厂家试剂有假阳性出现,2个厂家的试剂有最低检出限量参考品未检出。结论不同厂家的试剂质量存在明显差异,因此试剂使用前必须进行质量抽检,综合评价其质量。选择灵敏度高、特异性强的试剂,以提高献血者HBsAg的检测质量。

Objective To find out the difference among the various domestic HBsAg ELISA(enzyme-linked-immuno-absborbed assay) kits' quality and to choose the best one for the blood donators' selection.Methods Various brand HBsAg ELISA kits were evaluated one by one based on the national HBsAg panel.Results There was definitely different among the various 5 brand kits in the negative result-agreement rate,positive result-agreement rate and total result-agreement rate.As well as the sensitivity and accuracy.False positive sample was presented in 2 brand kits.The minimal concentration sample which should be detected was not checked out in 2 brand kits.Conclusions There was obviously different in various brand kits.So it is necessary to spot-check before using the HBsAg ELISA kit.And choosing the HBsAg ELISA kit with high sensitivity and specificity in order to improve the ability to test the donators' HBsAg.