Laboratory of Virology, "Lazzaro Spallanzani" National Institute for Infectious Diseases, IRCCS, 00149 Rome, Italy.
Eurospital SpA, Via Flavia 122, 34147 Trieste, Italy.
Viruses. 2021 Feb 3;13(2):236. doi: 10.3390/v13020236.
European Association of the Study of the Liver (EASL) guidelines specify HEV RNA, as well as anti-HEV IgG and IgM as positive markers for acute HEV infection. HEV RNA assay sensitivity limitations may lead to false negative test results in patients with low levels of viremia. Moreover, anti-HEV IgM positivity is not a reliable indicator for distinguishing between acute and resolved infections given the ability of this antibody to persist several months after a resolved infection. Our study aims were to assess HEV IgG avidity for diagnosing acute and resolved infections, regardless of the anti-HEV IgM serostatus, and examine assay reliability when evaluating different genotype 3 (GT3) HEV subtypes. Patient serum samples ( = 104) were tested for HEV IgG avidity by utilizing the DIA.PRO kit on a DSX automated instrument. Among patients identified with acute HEV infections, 32 were infected with GT3: GT3c ( = 5), GT3e ( = 8), 3f ( = 17) and GT3-unsubtyped ( = 2). Avidity sensitivity was 91.2% and specificity was 100%. For patients with long-lasting anti-HEV IgM persistence, an Avidity Index >70% was observed. Thus, the DIA.PRO avidity assay may be utilized to distinguish between recently acquired and resolved HEV GT3 infections. However, for equivocal results (Avidity Index > 40-70%), HEV RNA molecular testing will be required to confirm a recent infection.
欧洲肝脏研究协会(EASL)指南规定,HEV RNA 以及抗-HEV IgG 和 IgM 为急性 HEV 感染的阳性标志物。HEV RNA 检测的灵敏度限制可能导致低病毒血症患者的检测结果呈假阴性。此外,鉴于抗-HEV IgM 阳性在区分急性和已解决感染方面不是可靠的指标,因为这种抗体在已解决感染后可以持续数月,因此,抗-HEV IgM 阳性并不是区分急性和已解决感染的可靠指标。我们的研究目的是评估 HEV IgG 亲和力,以诊断急性和已解决的感染,无论抗-HEV IgM 血清状态如何,并检查在评估不同基因型 3 (GT3) HEV 亚型时检测的可靠性。利用 DSX 自动化仪器上的 DIA.PRO 试剂盒检测了 104 例患者的 HEV IgG 亲和力。在确定患有急性 HEV 感染的患者中,有 32 例感染 GT3:GT3c( = 5)、GT3e( = 8)、3f( = 17)和 GT3 未分型( = 2)。亲和力敏感性为 91.2%,特异性为 100%。对于长期存在抗-HEV IgM 持续存在的患者,观察到亲和力指数>70%。因此,DIA.PRO 亲和力检测可用于区分近期获得的和已解决的 HEV GT3 感染。然而,对于不确定的结果(亲和力指数>40-70%),需要进行 HEV RNA 分子检测以确认近期感染。