Comparison of second- and third-generation enzyme Immunoassays for detecting antibodies to hepatitis C virus
Comparison of second- and third-generation enzyme Immunoassays for detecting antibodies to hepatitis C virus
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DOI：
10.1128/jcm.40.5.1656-1659.2002
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发表时间：
2002-05-01
影响因子：
9.4
通讯作者：
Fix, AD
中科院分区：
文献类型：
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作者：
Abdel-Hamid, M;El-Daly, M;Fix, AD
补充测定，如重组免疫印迹测定（RIBA），用于确认丙型肝炎病毒（HCV）抗体的检测。然而，由于其成本，它们在发展中国家没有得到广泛使用。本研究的目的是比较第二代和第三代（分别为G2和G3）酶免疫测定（EIA）的结果，并通过使用补充测定来评估G2和G3 EIA确认抗HCV抗体阳性结果的可靠性来解决不一致的结果。我们对在埃及进行的一项以社区为基础的纵向研究的第二年期间收集的1，134份血清样本进行了G2和G3 EIA抗HCV抗体; 35份结果不一致的样本通过Abbott Laboratories Micro-Particle Immunoassay（M-EIA）和RIBA进行了检测。采用内部巢式逆转录酶PCR（RT-PCR）检测HCV RNA，确定病毒血症。两种检测（G2/G3）之间的一致性为96.9%; 87份（7.7%）样本为阳性，1，012份（89.2%）样本为阴性。17份样本的不一致结果为G2检测阴性和G3检测阳性，18份样本的不一致结果为G2检测阳性和G3检测阴性。17份G2阴性、G3阳性标本中，M-EIA阳性1份、5份，PCR阳性7份。在18份G2试验阳性和G3试验阴性的样品中，2份为M-EIA阳性，无PCR阳性。来自24个不一致样品的RIBA结果显示与G3 EIA的一致性为87.5%，与G2 Elk的一致性为12.5%，与M-EIA的一致性为95.8%。11份样本经RIBA检测为不确定，并从本分析中排除。基于RIBA结果，G3 EIA的灵敏度为9917，，而G2 EIA为89.8%，而G3 EIA的特异性为99.8%，而G2 EIA为98.9%。这些结果表明，在筛选这些血清的G3 EIA的可靠性是极好的，和G3测定可用于在资源有限的补充试验的情况下。RIBA似乎没有优势，较便宜的M-EIA筛选测定。RIBA的主要缺点是出现不确定的结果，特别是在有问题的样品中。在多次检测中给出不一致结果的样本通常是RIBA不确定的。
Supplemental assays, such as recombinant immunoblot assays (RIBA), are used to confirm detection of antibodies to hepatitis C virus (HCV). However, due to their expense, they are not widely used in developing countries. The purpose of our study was to compare the results of second- and third-generation (G2 and G3, respectively) enzyme immunoassays (EIAs) and to resolve discordant results by, using a supplemental assay to assess the reliability of G2 and G3 EIAs to confirm anti-HCV antibody-positive results. We performed both G2 and G3 EIAs for anti-HCV antibodies on 1,134 serum samples collected during the 2nd year of a longitudinal community-based study in Egypt; 35 samples with discordant results were tested by Abbott Laboratories Micro-Particle Immunoassay (M-EIA) and RIBA. Viremia was determined with an in-house nested reverse transcriptase PCR (RT-PCR) to detect HCV RNA. Concordance between the two assays (G2/G3) was 96.9%,; 87 (7.7%) samples were positive and 1,012 (89.2%) were negative by both assays. For 17 samples, the discordant results were G2 assay negative and G3 assay positive, and for 18 samples, the discordant results were G2 assay positive and G3 assay negative. Among the 17 G2 assay-negative and G3 assay-positive samples, 1,5, were M-EIA positive and 7 were PCR positive. Among the 18 G2 assay-positive and G3 assay-negative samples, 2 were M-EIA positive and none were PCR positive. RIBA results from 24 discordant samples showed 87.5% agreement with the G3 EIA, 12.5% agreement with the G2 Elk, and 95.8% agreement with M-EIA. Eleven samples were indeterminate by RIBA and excluded from this analysis. Based on RIBA results, the sensitivity of the G3 EIA was 9917,,, compared to 89.8% for the G2 EIA, while the specificity, of the G3 EIA was 99.8% compared to 98.9% for the G2 EIA. These results show that the reliability of the G3 EIA in screening these sera is excellent, and the G3 assay can be used in the absence of supplemental tests where resources are limited. RIBA appears not to have advantages over the less expensive M-EIA screening assay. The main disadvantage of RIBA is the occurrence of indeterminate results, especially among problematic samples. Samples giving discordant results in multiple assays are often indeterminate with the RIBA.