Sensitivity and specificity of third-generation hepatitis C virus antibody detection assays: an analysis of the literature
Sensitivity and specificity of third-generation hepatitis C virus antibody detection assays: an analysis of the literature
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DOI：
10.1046/j.1365-2893.2001.00280.x
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发表时间：
2001-03-01
影响因子：
2.5
通讯作者：
Trepo, C
中科院分区：
文献类型：
--
作者：
Colin, C;Lanoir, D;Trepo, C
本研究通过对文献的分析，评估了第三代丙型肝炎血清学诊断试验的敏感性和特异性。文献分析使用McMaster University的诊断测试评估标准进行。根据丙型肝炎病毒（HCV）感染高风险和低风险人群的类型以及参考检测的类型对所选研究进行分组。使用Fisher精确检验在每组中检验灵敏度和特异性的均一性。在132项研究中，选择了10项。当估计值均质时，计算汇总点估计值和置信区间，当估计值不均匀时，进行亚组分析，第三代酶联免疫吸附试验（ELISA 3）的敏感性估计为98.9%（95% CI：94-100%），在血清组中为97.2%（95% CI：92-99%）。在慢性肝病患者中，ELISA 3特异性为100%。在血液透析患者中，第三代重组免疫印迹试验（RIBA 3）的灵敏度为78.8%（95%CI：65-89%），该分析为ELISA 3试验的良好灵敏度和特异性提供了证据，特别是在高危患者群体中，并证实其可用于这些人群的筛查。需要进一步的研究来正确评估RIBA 3在一般人群和风险患者中的作用。
This study assessed the sensitivity and specificity of third-generation serological hepatitis C diagnostic tests from an analysis of the literature. The literature analysis was run using criteria from McMaster University for the assessment of diagnostic tests. The selected studies were grouped according to the type of population at high and low risk for hepatitis C virus (HCV) infection and to the type of reference test. The homogeneity of the sensitivity and the specificity was tested in each group using a Fisher's exact test. Of 132 studies, 10 were selected. When the estimates were homogeneous, summary point estimates and confidence intervals were computed; when the estimates were heterogeneous, subgroup analysis was performed.The sensitivity of third-generation enzyme-linked immunosorbent assay (ELISA3) was estimated at 98.9% (95% CI: 94-100%) in patients with chronic liver disease and at 97.2% (95% CI: 92-99%) in panels of sera. ELISA3 specificity was found at 100% in patients with chronic liver disease. The sensitivity of the third generation recombinant immunoblot assay (RIBA3) was assessed at 78.8% (95% CI: 65-89%) in haemodialysed patients.This analysis provides evidence for the good sensitivity and specificity of ELISA3 assays particularly in high risk patient groups and confirms their use for screening in these populations. Further studies are needed to assess properly RIBA3 in general population and in risk patients.