间接法和夹心法HCV抗体诊断试剂盒的诊断性能评价与选择

李永珍; 甄志军

doi:10.3969/j.issn.1001-5256.2014.10.017

间接法和夹心法HCV抗体诊断试剂盒的诊断性能评价与选择

DOI: 10.3969/j.issn.1001-5256.2014.10.017

河北省邢台市中心血站

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中图分类号: R446.6
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出版历程
- 收稿日期: 2013-12-06
- 出版日期: 2014-10-20

Evaluation and selection of indirect ELISA and sandwich ELISA kits for anti-HCV detection

Xingtai Blood Center

摘要

摘要: 目的对国产双抗原夹心酶联免疫法和间接酶联免疫法丙型肝炎抗原检测试剂进行诊断性能评价与选择。方法选择1种夹心法和3种间接法国产检测试剂,同时对60份血清盘标本和40份血液筛查标本进行检测,血液筛查标本的检测结果为阳性或灰区,并经确认试验确认。试剂间比较采用配对卡方检验;对假阴性率进行R×C列联表检验。结果 3种间接法试剂和夹心法试剂的灵敏度分别为90.2%、78.0%、95.1%和97.6%;特异度分别为78.1%、72.6%、94.1%和100%。夹心法的分析灵敏度比间接法高4~8倍,不同试剂及试剂组合的R×C列联表检验结果:χ2=29.898,P<0.05。结论夹心法试剂诊断特性优于间接法试剂,夹心法与间接法试剂搭配,可明显降低假阴性率,有效防止漏检。
- 肝炎抗体,丙型 /
- 试剂盒,诊断 /
- 酶联免疫吸附测定
Abstract: Objective To compare the sensitivity and specificity between indirect enzyme-linked immunosorbent assay ( ELISA) and double-antibody sandwich ELISA kits produced in China and to select the best ELISA kit. Methods Samples for evaluation included 60 serum plates and 40 serum samples positive or weakly positive for antibody to hepatitis C virus ( anti-HCV) which were confirmed by recombinant immunoblot assay. These samples were tested with a sandwich ELISA kit and three indirect ELISA kits, all of which were produced in China. Comparison between ELISA kits was made by paired chi-square test; comparison of false negative rate was made by R ×C contingency table test. Results The sensitivities of three indirect ELISA kits and a sandwich ELISA kit were 90. 2%, 78. 0%, 95. 1%, and 97. 6%, respectively, and the specificities were 78. 1%, 72. 6%, 94. 1%, and 100%, respectively. The sandwich ELISA kit had a 4-8 times higher sensitivity than indirect ELISA kits. The R × C contingency table test revealed significant differences in false negative rate between ELISA kits and combinations of ELISA kits ( χ2= 29. 898, P < 0. 05) . Conclusion Sandwich ELISA kit has higher sensitivity and specificity than indirect ELISA kits. Combined use of sandwich ELISA and indirect ELISA kits can significantly reduce the false negative rate and effectively prevent missed anti-HCV detection.
- hepatitis C antibodies /
- reagent kits, diagnostic /
- enzyme-linked immunosorbent assay

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参考文献(7)

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