Key result
Dia.Pro and Wantai HAV IgM ELISA kits demonstrated 100% sensitivity and specificity compared to the CLIA reference standard, whereas MBS New S.R.L. and Biogenix kits showed reduced sensitivities of 92.0% and 84.8%.
Why the study?
The study was conducted to evaluate the diagnostic performance of commercially available hepatitis A virus IgM index tests (ELISA and rapid ICTs) against a chemiluminescence immunoassay serological reference standard.
Do commercially available HAV IgM ELISA and rapid ICT kits accurately detect acute HAV infection compared to a CLIA reference standard in patients clinically suspected of acute hepatitis A?
Observational (n=250)
No
Do commercially available HAV IgM ELISA and rapid ICT kits accurately detect acute HAV infection compared to a CLIA reference standard in patients clinically suspected of acute hepatitis A?
Significant inter-assay variability exists among commercially available HAV IgM immunoassays, highlighting the need for careful selection of diagnostic platforms to ensure reliable detection of acute HAV infection.
Objectives: The objective of the study is to evaluate the diagnostic performance of commercially available hepatitis A virus (HAV) immunoglobulin M (IgM) index tests, specifically enzyme-linked immunosorbent assays (ELISA) and rapid immunochromatographic tests (ICTs), against a chemiluminescence immunoassay (CLIA) serological reference standard. Materials and Methods: The diagnostic performance of four commercially available HAV IgM ELISA kits (Dia.Pro, MBS New S.R.L., Wantai, and Biogenix) and three rapid ICT kits (Biogenix, Biotrol, and Insight) was evaluated using a CLIA as the reference comparator. An initial assessment was conducted using 48 well-characterized external quality assurance serum samples, followed by evaluation of 250 residual clinical serum samples. Statistical analysis: Statistical analysis was performed using MedCalc Statistical Software. Sensitivity, specificity, positive predictive value, and negative predictive value were calculated with 95% confidence intervals. Inter-assay agreement with the reference comparator was assessed using Cohen’s kappa (κ) coefficient. A p <0.05 was considered statistically significant. Results: Among the ELISA kits, Dia.Pro and Wantai demonstrated optimal performance with 100% sensitivity and specificity and perfect agreement with the reference comparator. MBS New S.R.L. and Biogenix ELISA kits showed lower sensitivities of 92.0 and 84.8%, respectively, despite high specificity. Among rapid ICT kits, only the Insight assay showed complete concordance with the reference method, whereas Biogenix and Biotrol ICT kits demonstrated reduced sensitivity. Conclusions: Significant inter-assay variability exists among commercially available HAV IgM immunoassays. Independent evaluation and careful selection of diagnostic platforms are essential to ensure reliable laboratory diagnosis of acute HAV infection.
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A 2026 study conducted an observational in Acute hepatitis A infection (n=250). Commercially available HAV IgM ELISA and rapid ICT kits vs. Architect HAV Ab-IgM CLIA was evaluated on Sensitivity of Dia.Pro and Wantai HAV IgM ELISA kits (95% CI 96.8-100.0). Dia.Pro and Wantai HAV IgM ELISA kits demonstrated 100% sensitivity and specificity compared to the CLIA reference standard, whereas MBS New S.R.L. and Biogenix kits showed reduced sensitivities of 92.0% and 84.8%.
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