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首页> 外文期刊>Transfusion: The Journal of the American Association of Blood Banks >Results of HCV screening of volunteer blood donors with a chemiluminescent immunoassay and a second- or third-generation EIA: overlap of false-positive reactivity and its impact on donor management.
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Results of HCV screening of volunteer blood donors with a chemiluminescent immunoassay and a second- or third-generation EIA: overlap of false-positive reactivity and its impact on donor management.

机译：使用化学发光免疫分析和第二代或第三代EIA进行志愿者献血者HCV筛查的结果：假阳性反应的重叠及其对献血者管理的影响。

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BACKGROUND: This study reports the results of adopting a strategy of anti-HCV testing of volunteer blood donors that uses a primary screening assay, two secondary EIAs (Anti-HCV Version III, Murex; Monolisa Anti-HCV New Antigens, Sanofi Pasteur), and a confirmatory immunoblot (HCV WB, Murex). STUDY DESIGN AND METHODS: A comparison was made of HCV test results from volunteer donors tested in two periods when different primary HCV screening assays were in use. The same two secondary screening assays and the same confirmatory test were used for the whole study. The two different primary assays were semi-automated second- or third-generation HCV EIA (Abbott Diagnostics) and an HCV chemiluminescent immunoassay (ChLIA), performed on a fully automated analyzer (PRISM, Abbott). RESULTS: During the period of use of the EIAs as primary screening assays, there were 60 donors per year who were confirmed as anti-HCV-positive, 29 who were classed as having indeterminate HCV serologic results, and 236 who were assessed as having biologically false-positive anti-HCV results. These numbers compared with 57, 52, and 320 such donors, respectively, in the first year of routine use of the ChLIA. The significant increase (p<0.05) in the number of anti-HCV-indeterminate donors after the introduction of the ChLIA was primarily due to an increase in donors who reacted on Monolisa HCV, but not an HCV Murex (expected 18/year vs. the observed 31/year, p<0.01). CONCLUSIONS: Compared to the second- or third-generation HCV EIA, the HCV ChLIA has a significantly greater overlap of false reactivity with the Monolisa HCV assay. This finding has implications for the selection of primary and secondary assays for anti-HCV screening of blood donors.
机译：背景：本研究报告了采用自愿性献血者抗HCV检测策略的结果，该策略使用一次筛查测定，两个次级EIA（Anti-HCV Version III，Murex; Monolisa Anti-HCV New Antigens，Sanofi Pasteur），和确认免疫印迹（HCV WB，Murex）。研究设计和方法：比较了使用两个主要HCV筛查方法的两个时期中来自自愿捐献者的HCV检测结果。整个研究使用相同的两个二次筛选测定法和相同的验证性测试。两种不同的主要检测方法是在全自动分析仪（PRISM，Abbott）上进行的半自动第二或第三代HCV EIA（Abbott Diagnostics）和HCV化学发光免疫检测（ChLIA）。结果：在将EIA用作主要筛查方法期间，每年有60位捐赠者被确认为抗HCV阳性，有29位被分类为不确定的HCV血清学结果，有236位被评估为具有生物学特性假阳性抗HCV结果。这些数字与常规使用ChLIA的第一年的此类捐赠者分别为57、52和320。引入ChLIA后，抗HCV不确定的供体数量显着增加（p <0.05），这主要是由于对Monolisa HCV而非HCV Murex反应的供体增加（预期18 /年vs.观察到的31 /年，p <0.01）。结论：与第二代或第三代HCV EIA相比，HCV ChLIA与Monolisa HCV测定的假反应性有明显更大的重叠。这一发现对献血者抗HCV筛查的主要和次要检测方法的选择具有影响。

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