Division of Viral Hepatitis, National Center for HIV, Hepatitis, STD and Tuberculosis Prevention, Centers for Disease Control and Prevention, Atlanta, Georgia, USA
Division of Viral Hepatitis, National Center for HIV, Hepatitis, STD and Tuberculosis Prevention, Centers for Disease Control and Prevention, Atlanta, Georgia, USA.
J Clin Microbiol. 2019 Feb 27;57(3). doi: 10.1128/JCM.01567-18. Print 2019 Mar.
An estimated 41,200 people were newly infected with hepatitis C virus (HCV) in 2016 in the United States. Screening tests for antibodies to HCV may generate up to 32% false positivity in low-risk populations. Current Centers for Disease Control and Prevention (CDC) screening recommendations do not require confirmatory testing of a screening anti-HCV-positive test; however, confirmation is valuable for surveillance in the absence of HCV RNA testing. A recombinant immunoblot assay (RIBA) was used as a confirmatory assay for anti-HCV-reactive samples but was discontinued in 2013. Another anti-HCV confirmatory assay, INNO-LIA, is commercially available in Europe but is not approved by the Food and Drug Administration (FDA) in the United States. We report the development of an anti-HCV assay that was performed on an automated immunoblot platform using a fourth-generation HCV recombinant fusion protein. Based on testing of 70 well-characterized samples, of which 40 were HCV RNA and anti-HCV positive, 15 were HCV RNA positive/anti-HCV negative, and 15 were HCV RNA and anti-HCV negative, the specificity and sensitivity of the HCV-WES assay were 100% and 95%, respectively. Concordance between INNO-LIA and HCV-WES was determined by testing 205 HCV RNA-negative/anti-HCV-positive samples, of which 149 (72.7%) were positive by HCV-WES, while 146 (71.2%) were positive by INNO-LIA. We have shown proof of concept for the use of this test for confirmation of screened anti-HCV results. The HCV-WES assay has advantages over manual Western blot assays and INNO-LIA, including ease of use, lower cost, and reduced hands-on time.
据估计，2016 年美国有 41200 人新感染丙型肝炎病毒（HCV）。HCV 抗体筛查试验在低危人群中可能产生高达 32%的假阳性。目前，疾病控制与预防中心（CDC）的筛查建议不要求对筛查抗 HCV 阳性检测进行确认性检测；然而，在没有 HCV RNA 检测的情况下，确认对于监测是有价值的。重组免疫印迹分析（RIBA）曾被用作抗 HCV 反应性样本的确认检测，但已于 2013 年停用。另一种抗 HCV 确认检测方法 INNO-LIA 在欧洲有市售，但未获得美国食品和药物管理局（FDA）的批准。我们报告了一种 HCV 检测方法的开发，该方法在自动化免疫印迹平台上使用第四代 HCV 重组融合蛋白进行检测。基于对 70 个特征明确的样本的测试，其中 40 个 HCV RNA 和抗 HCV 阳性，15 个 HCV RNA 阳性/抗 HCV 阴性，15 个 HCV RNA 和抗 HCV 阴性，HCV-WES 检测的特异性和敏感性分别为 100%和 95%。通过测试 205 个 HCV RNA 阴性/抗 HCV 阳性样本，确定了 INNO-LIA 与 HCV-WES 的一致性，其中 149 个（72.7%）HCV-WES 阳性，而 146 个（71.2%）INNO-LIA 阳性。我们已经证明了该检测用于确认筛选抗 HCV 结果的概念验证。与手动 Western blot 检测和 INNO-LIA 相比，HCV-WES 检测具有使用方便、成本降低和操作时间减少等优势。
