ArticleLiver international : official journal of the International Association for the Study of the Liver2026
Performance of Elecsys Anti-HEV IgG and IgM Assays for the Detection of Acute, Recent or Past Hepatitis E Virus Infection.
Article in Liver international : official journal of the International Association for the Study of the Liver, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
2 citing papers in PubMed.
- Evaluation of the analytical performance of the MAGLUMI HEV IgM and IgG assays for automated detection of HEV antibodies and comparison with the microplate Wantai assay.Virology journal · 2026Article
- Performance of Elecsys Anti-HEV IgG and IgM Assays for the Detection of Acute, Recent or Past Hepatitis E Virus Infection.Liver international : official journal of the International Association for the Study of the Liver · 2026Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
13 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
BACKGROUND &
aimsHepatitis 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.
methodsPerformance 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).
resultsRelative 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.
conclusionsThe 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.
Indexed as
Identifiers
What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.