比较双重抗体和抗原 HCV 免疫测定与标准护理算法检测。
Comparison of a dual antibody and antigen HCV immunoassay to standard of care algorithmic testing.
机构信息
Department of Pathology and Immunology, Washington University School of Medicine in St. Louis, Saint Louis, Missouri, USA.
Department of Pathology, University Hospitals Health System, Cleveland, Ohio, USA.
出版信息
J Clin Microbiol. 2024 Oct 16;62(10):e0083224. doi: 10.1128/jcm.00832-24. Epub 2024 Sep 16.
The Centers for Disease Control and Prevention (CDC) guidelines for hepatitis C virus (HCV) testing, although effective, may miss crucial diagnostic opportunities. The goal of this study was to assess the utility of an antibody (Ab) and antigen (Ag) combination immunoassay as an alternative to traditional HCV screening. Remnant specimens from 1,341 patients with concurrent third-generation serologic (Roche anti-HCV-II) and nucleic acid amplification testing (NAAT) were assessed using the HCV Duo Ab/Ag immunoassay (Roche). Patient demographics, risk factors, and standard of care (SOC) laboratory results from the medical records were recorded. Overall, 99.0% (197/199) of the HCV Duo Ab+/Ag+specimens accurately identified active infections as confirmed by NAAT, and 99.9% (670/671) Ab-/Ag- samples corresponded to those without HCV infections. Individually, the HCV Duo Ab component demonstrated a 95.6% positive percent agreement (PPA) (95% CI = 93.8-96.9) and 99.1% negative percent agreement (NPA) (98.8-99.6) compared with SOC anti-HCV II Ab assay. The HCV Duo Ag had a 73.5% PPA (67.9-78.4) and 99.8% NPA (99.3-100) with NAAT. Among RNA+ specimens, 73.4% (197/267) were HCV Duo Ag+, and 265/267 (99.3%) were successfully detected on the HCV Duo Ab component. Notably, 5/7 (71.4%) Ab-/RNA +specimens were detected by HCV Duo, which would have been missed by traditional algorithmic testing. Fourth generation HCV Duo Ab/Ag assay demonstrated comparable performance to SOC testing and shortens the diagnostic window but does not eliminate the need for NAAT in all patients. Ab/Ag testing identified several Ab-/RNA+ cases, a subgroup often undiagnosed by current algorithmic testing, demonstrating promise for improved diagnostic efficiency and accuracy in HCV detection.IMPORTANCEThis study highlights the potential of a combined hepatitis C virus (HCV) Duo antibody (Ab) and antigen (Ag) immunoassay to improve early detection of HCV infections. Traditional Ab-only screening methods recommended by the Centers for Disease Control and Prevention may miss early-stage infections. The HCV Duo assay showed high accuracy, detecting nearly all active infections confirmed by nucleic acid amplification testing. Dual detection of HCV Ab and Ag shortens the diagnostic window, enabling intervention and treatment in a single visit, which is crucial for improving patient outcomes and reducing HCV transmission, especially in areas with limited access to confirmatory molecular testing.
美国疾病控制与预防中心（CDC）的丙型肝炎病毒（HCV）检测指南虽然有效，但可能会错过关键的诊断机会。本研究的目的是评估抗体（Ab）和抗原（Ag）组合免疫测定作为传统 HCV 筛查的替代方法的效用。对 1341 例同时进行第三代血清学（罗氏抗 HCV-II）和核酸扩增检测（NAAT）的患者的残余标本进行了评估，使用 HCV Duo Ab/Ag 免疫测定（罗氏）。记录患者的人口统计学、危险因素和病历中的标准护理（SOC）实验室结果。总体而言，99.0%（197/199）的 HCV Duo Ab+/Ag+标本通过 NAAT 准确识别出活跃感染，99.9%（670/671）的 Ab-/Ag-标本与未感染 HCV 的标本相对应。单独来看，HCV Duo Ab 成分的阳性百分比符合率（PPA）为 95.6%（95%CI=93.8-96.9），阴性百分比符合率（NPA）为 99.1%（98.8-99.6），与 SOC 抗 HCV II Ab 检测相比。HCV Duo Ag 的 PPA 为 73.5%（67.9-78.4），NPA 为 99.8%（99.3-100），与 NAAT 相比。在 RNA+标本中，73.4%（197/267）为 HCV Duo Ag+，267/267（99.3%）在 HCV Duo Ab 成分上成功检测到。值得注意的是，5/7（71.4%）的 Ab-/RNA +标本被 HCV Duo 检测到，这将被传统的算法检测所遗漏。第四代 HCV Duo Ab/Ag 检测与 SOC 检测具有相当的性能，缩短了诊断窗口期，但不能消除所有患者对 NAAT 的需求。Ab/Ag 检测发现了一些 Ab-/RNA+病例，这是当前算法检测经常漏诊的亚组，这表明在 HCV 检测中提高诊断效率和准确性具有很大的潜力。重要性本研究强调了联合丙型肝炎病毒（HCV）Duo 抗体（Ab）和抗原（Ag）免疫测定在早期检测 HCV 感染方面的潜力。美国疾病控制与预防中心推荐的传统 Ab 单筛查方法可能会错过早期感染。HCV Duo 检测具有很高的准确性，几乎能检测到所有通过核酸扩增检测确认的活跃感染。HCV Ab 和 Ag 的双重检测缩短了诊断窗口期，可在单次就诊时进行干预和治疗，这对于改善患者结局和减少 HCV 传播至关重要，尤其是在无法获得确认性分子检测的地区。
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