León P, López J A, Domingo C, Echevarría J M
Department of Diagnosis, Centro Nacional de Microbiología, Madrid, Spain.
Transfusion. 1993 Mar;33(3):268-70. doi: 10.1046/j.1537-2995.1993.33393174455.x.
An evaluation study, involving 11 screening methods for the detection of antibody to hepatitis C virus (anti-HCV) and a panel of 500 serum samples, was performed. Samples were tested by all 11 methods, and those showing reactivity in at least one method were studied by a combination of supplemental assays (recombinant immunoblot assays, first and second generation; neutralization test for anti-c100; synthetic peptide immunoblot assay; recombinant multi-dot immunoassay) and classified as positive (110 samples), indeterminate (4 samples), or negative (386 samples) on the basis of the results obtained. Second-generation recombinant methods performed better on positive samples than first-generation assays or synthetic peptide-based methods (99.1-100% correlation vs. 64.5-85.5% and 93.6-99.1%, respectively), whereas the latter showed higher correlations on negative samples than recombinant assays (97.4-99.7% vs. 82.4-93%). Further investigations, using broad panels of indeterminate samples from blood donors, should be done, however, before synthetic peptide-based methods are recommended for blood bank screening. Reactivity of samples must be confirmed by one supplemental test in all cases before the donor is informed. In some cases, it may require the use of two or more different tests to obtain definite conclusions.
开展了一项评估研究，涉及11种用于检测丙型肝炎病毒抗体（抗-HCV）的筛查方法和一组500份血清样本。所有11种方法都对样本进行了检测，对至少在一种方法中显示出反应性的样本，通过补充检测组合（重组免疫印迹检测，第一代和第二代；抗-c100中和试验；合成肽免疫印迹检测；重组多点免疫检测）进行研究，并根据所得结果分为阳性（110份样本）、不确定（4份样本）或阴性（386份样本）。第二代重组方法在阳性样本上的表现优于第一代检测方法或基于合成肽的方法（相关性分别为99.1-100%，而第一代检测方法和基于合成肽的方法分别为64.5-85.5%和93.6-99.1%），而后者在阴性样本上的相关性高于重组检测方法（97.4-99.7%，而重组检测方法为82.4-93%）。然而，在推荐基于合成肽的方法用于血库筛查之前，应使用来自献血者的大量不确定样本进行进一步研究。在告知献血者之前，所有情况下样本的反应性都必须通过一项补充检测来确认。在某些情况下，可能需要使用两种或更多不同的检测来得出明确结论。
