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首页> 外文期刊>Transfusion: The Journal of the American Association of Blood Banks >A multi-Chinese blood center study testing serologic-negative donor samples for hepatitis C virus and human immunodeficiency virus with nucleic acid testing.
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A multi-Chinese blood center study testing serologic-negative donor samples for hepatitis C virus and human immunodeficiency virus with nucleic acid testing.

机译：一家多方中国血液中心的研究，通过核酸检测对血清学阴性的供体样本进行了丙型肝炎病毒和人类免疫缺陷病毒的检测。

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BACKGROUND: A multi-blood center study was conducted to evaluate a human immunodeficiency virus type 1 (HIV-1) and hepatitis C virus (HCV) multiplex nucleic acid testing (NAT) donor screening test and to determine the residual risk for HIV-1 and HCV infection. STUDY DESIGN AND METHODS: A commercially available HIV-1 and HCV assay (Procleix, Chiron Corp.) was used for simultaneous detection of HIV-1 RNA and HCV RNA on 89,647 unlinked donor samples. NAT was performed with pools of 16 samples that had passed all routine screening tests. Single-donor NAT was performed for samples that had been disqualified by any reactive screening test result(s). Anti-HCV (Ortho third-generation HCV enzyme immunoassay [EIA]), alanine aminotransferase, and HCV NAT (Roche COBAS Amplicor HCV test) confirmatory tests were used for HCV EIA-nonreactive, HCV NAT-reactive samples. RESULTS: Three HCV NAT yield cases and no HIV-1 yield cases were detected. The yield rate for HCV NAT was 3.4 per 10(5) (95 percent confidence interval[CI], 0.7-9.8). The estimated incidence rate for HCV is 24.2 per 100,000 person-years (95% CI, 3.4-88.0). If minipool NAT is added to routine donor screening, the residual risk for HCV is estimated to be reduced to 1 in 20.4x10(4) (95% CI, 1 in 5.2x10(4)-1 in 165.5x10(4)). CONCLUSION: The residual risk for transfusion-transmitted HCV infection is still relatively high in China. Incorporating NAT technology into blood donor screening would be estimated to reduce the residual risk of HCV infections eightfold over current EIA screening.
机译：背景：进行了多中心研究，以评估人类1型免疫缺陷病毒（HIV-1）和丙型肝炎病毒（HCV）多重核酸测试（NAT）供体筛选测试，并确定HIV-1的残留风险和HCV感染。研究设计和方法：使用市售的HIV-1和HCV检测方法（Procleix，Chiron Corp.）用于同时检测89,647个未连接的供体样品上的HIV-1 RNA和HCV RNA。 NAT是通过16个样品池进行的，这些样品池已通过所有常规筛选测试。对任何反应性筛选测试结果不合格的样品进行单供体NAT。抗HCV（Ortho第三代HCV酶免疫法[EIA]），丙氨酸转氨酶和HCV NAT（Roche COBAS Amplicor HCV测试）确证测试用于HCV EIA非反应性，HCV NAT反应性样品。结果：3 HCV NAT产量案件和没有HIV-1产量案件被查出。 HCV NAT的产率为3.4 / 10（5）（95％置信区间[CI]为0.7-9.8）。 HCV的估计发病率是每100,000人年24.2（95％CI，3.4-88.0）。如果将minipool NAT添加到常规供体筛查中，则HCV的残留风险估计将降低为20.4x10（4）中的1（95％CI，165.5x10（4）中5.2x10（4）-1的1）。结论：中国输血传播的HCV感染的残留风险仍然相对较高。据估计，将NAT技术纳入献血者筛查可将HCV感染的残留风险降低到目前EIA筛查的八倍。

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