Division of HIV and Other Retroviruses, Robert Koch Institute, Berlin, Germany.
Division of HIV and Other Retroviruses, Robert Koch Institute, Berlin, Germany; Institute of Virology, Charité Universitätsmedizin Berlin, Berlin, Germany.
J Virol Methods. 2020 May;279:113839. doi: 10.1016/j.jviromet.2020.113839. Epub 2020 Feb 19.
Hepatitis C virus (HCV) antigen/antibody (Ag/Ab) assays offer the benefit of reducing the window period compared to assays that detect only HCV-Ab. In this study the performance of the Murex Ag/Ab (Murex, Abbott) and Monolisa Ag/Ab Ultra (Monolisa, Bio-Rad) ELISAs was compared for the use of filter dried serum/plasma spots (DS/PS) with a focus on the sensitivity and the percentage of correct positive test results. Correct positive ELISA results were assumed for samples that subsequently tested positive for HCV RNA by RT-qPCR, or RNA negative samples that tested positive in a Western blot (confirmed ELISA results). Sensitivity was evaluated from DS/PS eluates using HCV seroconversion panels [plasma samples of subtypes-(St) 1a, 2b)] and longitudinal HCV antibody positive serum panels (St 1b, 2b, 3a, and 4d). The proportion of correct positive test results was evaluated using 1102 newly diagnosed HIV positive clinical dried serum spots (DSS) eluates for screening of potential HCV co-infection. For the plasma HCV seroconversion samples, which were used as a reference for DSS eluates, the Murex became reactive earlier for antigen positive bleeds. However, for the HCV antibody positive eluates and dilutions thereof, the Monolisa demonstrated a superior sensitivity. Of the clinical DSS 22.8 % (28/123) of samples reactive in the Murex were negative in a subsequent RT-qPCR and Western blot, while only 1.9 % (2/105) of the samples reactive in the Monolisa were negative in these confirmatory assays. Our results indicate that the Monolisa provides fewer false positive results for HCV detection in DSS, whereas for undiluted plasma or serum samples, the Murex can serve as an additional diagnostic tool to narrow the window period.
丙型肝炎病毒（HCV）抗原/抗体（Ag/Ab）检测试剂盒的优势在于，与仅检测 HCV-Ab 的检测试剂盒相比，其可以缩短窗口期。本研究对比了 Murex Ag/Ab（Murex，雅培）和 Monolisa Ag/Ab Ultra（Monolisa，伯乐）ELISA 检测试剂盒用于滤纸片干血斑/血浆斑（DS/PS）的性能，重点关注其灵敏度和正确阳性检测结果的百分比。假设通过 RT-qPCR 检测 HCV RNA 呈阳性的样本、或 Western blot 呈阳性但 RNA 为阴性的样本（经确认的 ELISA 结果）的 ELISA 结果为正确阳性。灵敏度通过使用 HCV 血清转换试剂盒（血浆样本为亚型 1a、2b）和 HCV 抗体阳性血清试剂盒（1b、2b、3a 和 4d）对 DS/PS 洗脱液进行评估。通过 1102 份新诊断的 HIV 阳性临床干血斑（DSS）洗脱液对潜在 HCV 合并感染进行筛查，评估了正确阳性检测结果的比例。对于作为 DSS 洗脱液参考的血浆 HCV 血清转换样本，Murex 对抗原阳性出血的反应更早。然而，对于 HCV 抗体阳性洗脱液及其稀释液，Monolisa 的灵敏度更高。在 123 份 Murex 反应性临床 DSS 样本中，22.8%（28/123）的样本在后续 RT-qPCR 和 Western blot 中为阴性，而在 Monolisa 反应性样本中，只有 1.9%（2/105）的样本在这些确认性检测中为阴性。我们的研究结果表明，Monolisa 可减少 HCV 在 DSS 检测中的假阳性结果，而对于未稀释的血浆或血清样本，Murex 可作为缩短窗口期的辅助诊断工具。
