[国内丙型肝炎病毒IgG抗体ELISA检测试剂盒比较]。

中华实验和临床病毒学杂志 Pub Date : 2013-06-01
Qing-Ling Meng, Jian Lu, Feng Qiu, Hai-Yan Shi, Yong-Zhen Jiang, Hong-Lan Zhao, Feng Wang
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引用次数: 0

摘要

目的:比较国内市面上常见的丙型肝炎病毒IgG抗体检测试剂,为丙型肝炎预防提供参考。方法:选择A、B、C、D、E、F 6家企业生产的HCV- igg检测试剂,对160份HCV似是而非的血清进行检测。采用ABBOTT公司的HCV-IgG试剂为金标准品,灰色区样品最后采用RIBA法测定。结果:160份血清中阳性88份,阴性72份。6家企业的试剂与金标准品的总符合率为88.13% ~ 98.13%,约登指数为0.74 ~ 0.96。D试剂的符合性最高,为98.13%,约登指数最高,为0.96。结论:6家企业的HCV-IgG抗体检测试剂与ABBOTT试剂比较,总符合率均在88%以上。它非常舒适。然而,一些试剂被证明在阴性样品检测中不太符合。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
[Comparison of ELISA diagnostic kits used in China for hepatitis C virus IgG antibody detection].

Objective: To compare the commercial diagnostic reagent available in China for hepatitis C virus ( HCV) IgG antibody detection in order to provide some useful information for HCV prevention.

Methods: The HCV-IgG detection reagents produced by six different Enterprises named A, B, C, D, E and F were chosen and applied to detect 160 HCV specious sera samples. HCV-IgG reagent from ABBOTT was adopted as gold-standard and the samples in gray zone were determined by RIBA method finally.

Results: 160 sera samples comprised 88 positive samples and 72 negative samples. The total conformity ranged from 88.13% to 98.13% and the Youden indexes ranged from 0.74 to 0.96 when the reagents from six different Enterprises were compared with gold-standard. The highest conformity was 98.13%, observed in D reagent with the highest Youden index of 0.96.

Conclusion: The total conformity rates were more than 88% when the HCV-IgG antibody detection reagents from six different Enterprises were compared with ABBOTT reagent. It was highly conformable. However, some reagent proved to be less conformable in negative samples detection.

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