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Войти в исследования Liver international : official journal of the International Association for the Study of the Liver · 2026
Performance of Elecsys Anti-HEV IgG and IgM Assays for the Detection of Acute, Recent or Past Hepatitis E Virus Infection.
СтатьяМногоцентровое исследованиеПоддержка исследования: вне правительства СШАНазвание и аннотация: Перевод в очереди
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Schemmerer Mathias, Pflüger Lisa Sophie, Schneider Tanja, Lu Jie, Kienle Korbinian, Meyer-Schlinkmann Kristin Maria, Mühlbacher Annelies, Polz Johannes, Schennach Harald, Xie Qing, Voitenleitner Christian, Wenzel Jürgen, Lütgehetmann Marc
Аннотация
BACKGROUND & AIMS: Hepatitis E virus (HEV) is the leading cause of acute viral hepatitis. We evaluated the performance of the new automated Elecsys Anti-HEV IgG and Elecsys Anti-HEV IgM assays (Roche Diagnostics) in detecting acute, recent and past HEV infection.
METHODS: Performance of the Elecsys assays relative to three commercially available CE-IVD anti-HEV assays was assessed in a large multinational cohort (six laboratories in Germany, Austria and China). Sensitivity testing included samples from patients with presumed acute (IgM: n = 707; IgG: n = 490) and recovered HEV infection (n = 156). Specificity testing included samples from asymptomatic blood donors (n = 5040), routine diagnostic samples (n = 2427), and pregnant women (n = 544). An in-house anti-HEV IgG neutralisation method was performed to resolve discrepant specificity sample results. Seroconversion sensitivity analysis was performed using nine commercial seroconversion panels (n = 119 samples).
RESULTS: Relative sensitivity and specificity of the Elecsys assays were > 98.6% (95% CI: 92.2%-100%) and > 98.9% (98.4%-99.2%) for anti-HEV IgM and > 81.2% (79.3%-83.0%) for anti-HEV IgG in different cohorts, respectively. After confirming anti-HEV IgG in 680/696 discrepant samples by a neutralisation method, relative specificity of the Elecsys Anti-HEV IgG assay was > 99.4% (98.8%-99.7%). Evaluation of commercial seroconversion panels showed good overall agreement between the assays.
CONCLUSIONS: The Elecsys Anti-HEV IgG and IgM assays showed favourable overall performance when compared to three commercially available CE-IVD marked assays. Neutralisation data indicated higher sensitivity of the Elecsys Anti-HEV IgG assay than comparator assays in detecting past infections and lower IgG concentrations.
METHODS: Performance of the Elecsys assays relative to three commercially available CE-IVD anti-HEV assays was assessed in a large multinational cohort (six laboratories in Germany, Austria and China). Sensitivity testing included samples from patients with presumed acute (IgM: n = 707; IgG: n = 490) and recovered HEV infection (n = 156). Specificity testing included samples from asymptomatic blood donors (n = 5040), routine diagnostic samples (n = 2427), and pregnant women (n = 544). An in-house anti-HEV IgG neutralisation method was performed to resolve discrepant specificity sample results. Seroconversion sensitivity analysis was performed using nine commercial seroconversion panels (n = 119 samples).
RESULTS: Relative sensitivity and specificity of the Elecsys assays were > 98.6% (95% CI: 92.2%-100%) and > 98.9% (98.4%-99.2%) for anti-HEV IgM and > 81.2% (79.3%-83.0%) for anti-HEV IgG in different cohorts, respectively. After confirming anti-HEV IgG in 680/696 discrepant samples by a neutralisation method, relative specificity of the Elecsys Anti-HEV IgG assay was > 99.4% (98.8%-99.7%). Evaluation of commercial seroconversion panels showed good overall agreement between the assays.
CONCLUSIONS: The Elecsys Anti-HEV IgG and IgM assays showed favourable overall performance when compared to three commercially available CE-IVD marked assays. Neutralisation data indicated higher sensitivity of the Elecsys Anti-HEV IgG assay than comparator assays in detecting past infections and lower IgG concentrations.