Chiu Chia-Yu, Razonable Raymund R, Yao Joseph D, Watt Kymberly D, Chesdachai Supavit
Department of Medicine, Division of Public Health, Infectious Diseases, and Occupational Medicine, Mayo Clinic, Rochester, Minnesota, USA.
Department of Medicine, Division of Infectious Diseases, University of Colorado School of Medicine, Aurora, Colorado, USA.
Hepatol Commun. 2024 Dec 11;9(1). doi: 10.1097/HC9.0000000000000611. eCollection 2025 Jan 1.
Diagnostic uncertainty caused by the low positive predictive value of HEV-specific IgM antibody (Ab) testing in a low-prevalence setting. We investigated the utility of a two-step HEV IgM Ab testing approach for diagnosing HEV infection.
We retrospectively reviewed all adults who underwent HEV IgM Ab and/or HEV RNA testing from July 2013 through June 2023 at Mayo Clinic. Two-step HEV IgM testing involved initial testing using recomWell HEV IgM ELISA (Mikrogen, Neuried, Germany), with reflex to recomLine HEV IgM Strip (Mikrogen, Neuried, Germany) on all recomWell HEV IgM-reactive or IgM-equivocal specimens, as recomLine HEV IgM has higher specificity than recomWell HEV IgM but is more labor-intensive.
A total of 1640 patients had HEV IgM Ab or HEV RNA testing, including 1293 (79%) with only HEV IgM Ab testing, 213 (13%) with only HEV RNA testing, and 134 (8%) with both HEV IgM Ab and HEV RNA testing. Eighteen HEV infections were diagnosed with acute (N=16) and chronic (N=2) infections. Two-step IgM Ab testing did not identify 2 solid organ transplant recipients with chronic HEV infection. In acute HEV infection with HEV viremia, 3 out of 4 patients (2 solid organ transplant recipients and 1 patient with Guillain-Barre syndrome) were treated with ribavirin.
A two-step HEV IgM Ab test may accurately diagnose acute HEV infection in immunocompetent persons. However, this approach fails to identify chronic HEV infection in immunocompromised individuals who need HEV RNA testing to establish the diagnosis.
在低流行环境中，戊型肝炎病毒（HEV）特异性IgM抗体检测的阳性预测值较低，导致诊断存在不确定性。我们研究了两步法HEV IgM抗体检测方法在诊断HEV感染中的效用。
我们回顾性分析了2013年7月至2023年6月在梅奥诊所接受HEV IgM抗体和/或HEV RNA检测的所有成年人。两步法HEV IgM检测包括最初使用重组戊型肝炎病毒IgM酶联免疫吸附测定（recomWell HEV IgM ELISA，德国米克罗根公司，诺伊里德）进行检测，对所有recomWell HEV IgM反应性或IgM疑似标本进行重组戊型肝炎病毒IgM试纸条（recomLine HEV IgM Strip，德国米克罗根公司，诺伊里德）复检，因为recomLine HEV IgM比recomWell HEV IgM具有更高的特异性，但操作更繁琐。
共有1640例患者进行了HEV IgM抗体或HEV RNA检测，其中1293例（79%）仅进行了HEV IgM抗体检测，213例（13%）仅进行了HEV RNA检测，134例（8%）同时进行了HEV IgM抗体和HEV RNA检测。确诊了18例HEV感染，包括急性感染（n = 16）和慢性感染（n = 2）。两步法IgM抗体检测未识别出2例慢性HEV感染的实体器官移植受者。在伴有HEV病毒血症的急性HEV感染中，4例患者中有3例（2例实体器官移植受者和1例吉兰 - 巴雷综合征患者）接受了利巴韦林治疗。
两步法HEV IgM抗体检测可能准确诊断免疫功能正常者的急性HEV感染。然而，这种方法无法识别免疫功能低下个体中的慢性HEV感染，这些个体需要进行HEV RNA检测以确诊。
