[Evaluations of 5 kinds of China-made enzyme immunoassay kits for hepatitis B virus surface antigen detection].

中国疫苗和免疫 Pub Date : 2009-10-01

Yong Zhang, Feng Wang, Jing-Chen Ma

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Abstract

Unlabelled: OBJECTIVE To Screen best EIA kit that fits best for using in serological detection of HBsAg in the national investigation of hepatitis B virus infection.

Methods: Top 5 kinds of kits on the best seller list of China-made HBsAg EIA detection reagents were selected and each was detected the HBsAg panel (63 positive and 90 negative) 5 times. The s/n ratio of each test was recorded and transformed by log (s/n+1). Reliability indices ICC and CV, and validity indices AUC, pAUC and Se(FPR-e) were calculated and compared between each of the kits.

Results: The indices of ICC and CV of the 5 kits arranged in the same order of E, C, D, B and A, from the best to the worst, and the differences between them were significantly important (Bootstrap method, P < 0.05); The AUCs ranged from 0.965 to 0.987, and for kits E and B which had the biggest pAUCs, differs significantly from kits A and D (Bootstrap method, P < 0.05). Kit E had the highest Se(FPR-e) which was significantly bigger than kit B (Bootstrap method, P < 0.05).

Conclusion: The 5 kinds of kits are all excellent and kit E is the best.

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[5种国产乙型肝炎病毒表面抗原酶免疫测定试剂盒的评价]。

目的:筛选最适合在全国乙型肝炎病毒感染调查中用于HBsAg血清学检测的EIA试剂盒。方法:选取国产HBsAg EIA检测试剂畅销榜前5种试剂盒，各检测5次(阳性63次，阴性90次)。记录每次试验的s/n比，用log (s/n+1)变换。计算并比较各试剂盒的信度指标ICC、CV和效度指标AUC、pac、Se(FPR-e)。结果:5个试剂盒的ICC、CV指标按E、C、D、B、A等次排列，从好到坏，差异均有统计学意义(Bootstrap法，P < 0.05);auc范围为0.965 ~ 0.987,pac最大的试剂盒E和B与试剂盒A、D差异显著(Bootstrap法，P < 0.05)。试剂盒E的Se(FPR-e)最高，显著大于试剂盒B (Bootstrap法，P < 0.05)。结论:5种试剂盒均为优良，以E试剂盒为最佳。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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中国疫苗和免疫

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