Analytical performance evaluation of commercially available hepatitis A virus IgM immunoassays: ELISA, ICTs, and chemiluminescence immunoassay
Rajeev Kumar Jain, Rakesh Kumar Shrivastava, Ankita Agarwal, Kamlesh Kumar Ahirwar, Deepti Chaurasia, Nagaraj PerumalObjectives:
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.