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对比抗-HCV 联合 HCVcAg(Elecsys HCV Duo 免疫分析法)与抗-HCV 快速检测,随后采用 qRT-PCR 分析 HCV RNA 以确定治疗的活动性感染。

Comparison of anti-HCV combined with HCVcAg (Elecsys HCV Duo immunoassay) and anti-HCV rapid test followed by HCV RNA analysis using qRT-PCR to identify active infection for treatment.

机构信息

Center of Excellence in Clinical Virology, Department of Pediatrics, Faculty of Medicine, Chulalongkorn University, Bangkok, Thailand.

Center of Excellence in Osteoarthritis and Musculoskeleton, Faculty of Medicine, King Chulalongkorn Memorial Hospital, Thai Red Cross Society, Chulalongkorn University, Bangkok, Thailand.

出版信息

PLoS One. 2024 Nov 18;19(11):e0313771. doi: 10.1371/journal.pone.0313771. eCollection 2024.

DOI:10.1371/journal.pone.0313771
PMID:39556526
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC11573151/
Abstract

Hepatitis C virus (HCV) infection can cause acute and chronic hepatitis, leading to liver cirrhosis and hepatocellular carcinoma. The World Health Organization aims to eliminate viral hepatitis by 2030 through extensive screening and treatment. To achieve this goal, comprehensive and widespread screening is essential for diagnosis and treatment. This study aims to evaluate the diagnostic sensitivity and specificity of the Elecsys® HCV Duo immunoassay (Duo-assay), which simultaneously detects anti-HCV antibodies (Duo/anti-HCV) and HCV core antigen (Duo/HCVcAg) in a single sample, compared with initially antibody testing followed by quantitative real-time polymerase chain reaction (qRT-PCR). Additionally, this study aimed to evaluate a relationship between Duo/HCVcAg and qRT-PCR assay in different genotypes. A total of 769 plasma samples were tested using the Duo-assay to further evaluate the test's performance and conduct Duo/HCVcAg correlation analysis using qRT-PCR for each genotype. Among the active infection group (anti-HCV+/RNA+; n = 473), the Duo-assay showed 100% sensitivity for detecting Duo/anti-HCV and 70.6% for Duo/HCVcAg. In the resolved infection group (anti-HCV+/RNA-; n = 176), the assay showed 100% sensitivity for Duo/anti-HCV and 100% specificity for Duo/HCVcAg. In the non-infected group (anti-HCV-/RNA-; n = 120), the assay showed 100% specificity for both Duo/anti-HCV and Duo/HCVcAg. Moreover, no correlation was observed between the Duo/HCVcAg and HCV RNA tests, irrespective of genotype. These findings indicate that the Duo-assay is highly sensitive for detecting anti-HCV and specifically identifies patients with active infection. Nevertheless, cases with anti-HCV+/HCVcAg-results should undergo additional confirmation with western blot/immunoblot and qRT-PCR to ensure diagnostic accuracy, especially in Blood donation facilities.

摘要

丙型肝炎病毒(HCV)感染可引起急性和慢性肝炎,导致肝硬化和肝细胞癌。世界卫生组织(WHO)的目标是到 2030 年通过广泛的筛查和治疗消除病毒性肝炎。为了实现这一目标,全面广泛的筛查对于诊断和治疗至关重要。本研究旨在评估 Elecsys® HCV Duo 免疫测定法(Duo-assay)的诊断灵敏度和特异性,该方法可在单个样本中同时检测抗 HCV 抗体(Duo/anti-HCV)和 HCV 核心抗原(Duo/HCVcAg)。与最初的抗体检测后进行定量实时聚合酶链反应(qRT-PCR)相比,该研究还旨在评估 Duo/HCVcAg 与不同基因型的 qRT-PCR 检测之间的关系。共对 769 份血浆样本进行了 Duo-assay 检测,以进一步评估该检测的性能,并对每个基因型进行 Duo/HCVcAg 相关性分析。在活动性感染组(anti-HCV+/RNA+;n=473)中,Duo-assay 检测 Duo/anti-HCV 的灵敏度为 100%,检测 Duo/HCVcAg 的灵敏度为 70.6%。在已解决感染组(anti-HCV+/RNA-;n=176)中,该检测方法对 Duo/anti-HCV 的灵敏度为 100%,对 Duo/HCVcAg 的特异性为 100%。在未感染组(anti-HCV-/RNA-;n=120)中,该检测方法对 Duo/anti-HCV 和 Duo/HCVcAg 的特异性均为 100%。此外,无论基因型如何,Duo/HCVcAg 和 HCV RNA 检测之间均无相关性。这些发现表明,Duo-assay 对检测抗 HCV 非常敏感,并且特异性识别出具有活动性感染的患者。然而,对于出现抗 HCV+/HCVcAg-结果的病例,应使用 Western blot/immunoblot 和 qRT-PCR 进行进一步确认,以确保诊断准确性,特别是在血液采集机构中。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/5f39/11573151/c9cceda49d26/pone.0313771.g004.jpg
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https://cdn.ncbi.nlm.nih.gov/pmc/blobs/5f39/11573151/c9cceda49d26/pone.0313771.g004.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/5f39/11573151/2783f84832d7/pone.0313771.g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/5f39/11573151/2f6f36d30455/pone.0313771.g002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/5f39/11573151/6b0c68644206/pone.0313771.g003.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/5f39/11573151/c9cceda49d26/pone.0313771.g004.jpg

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An amino acid substitution in HCV core antigen limits its use as a reliable measure of HCV infection compared with HCV RNA.与 HCV RNA 相比,丙型肝炎病毒核心抗原中的一个氨基酸取代限制了其作为 HCV 感染可靠指标的用途。
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