microbiology, hepatitis E

BackgroundHepatitis E virus (HEV) is a major cause of acute hepatitis worldwide. In the Czech Republic, genotype 3 predominates, transmitted mainly through undercooked meat. Reliable diagnostics are critical for detecting infections and assessing seroprevalence. Modern assays using recombinant HEV ORF2 proteins offer greater sensitivity than older methods. This study aimed to compare the performance of ELISA, immunoblot, and Elecsys anti-HEV IgM and IgG tests.MethodsEighty serum samples from organ and haematopoietic cell donors at the University Hospital Ostrava were analyzed. These samples, collected between 2022 and 2024, had tested positive for anti-HEV IgG or IgM using the Elecsys method (Roche Diagnostics). The assays evaluated included: Immunoblot recomLine HEV IgG/IgM (Mikrogen), ELISA recomWell HEV IgG/IgM (Mikrogen), HEV IgG/IgM ELISA (Wantai, DIA.PRO, Euroimmun). The Elecsys anti-HEV method served as the reference standard.ResultsFor anti-HEV IgG, the immunoblot recomLine test showed the highest concordance with ECLIA at 78.7% (63/80 samples). Among ELISA methods, recomWell (Mikrogen) had the best agreement at 48.7% (39/80), followed by Wantai (45.0%, 36/80), and Euroimmun (43.75%, 35/80). DIA.PRO showed the lowest concordance at 41.2% (33/80). For anti-HEV IgM, ECLIA detected three positive samples, and the immunoblot recomLine assay demonstrated 100% concordance. All ELISA methods were negative for anti-HEV IgM, indicating lower sensitivity compared to ECLIA.ConclusionsECLIA demonstrated the highest sensitivity and reliability for HEV diagnostics, making it the most suitable method for clinical use. The immunoblot recomLine test showed good concordance and is useful for confirmatory testing. However, ELISA methods showed limited sensitivity, particularly for IgM detection. For accurate diagnosis and reliable seroprevalence studies, ECLIA is strongly recommended as the primary diagnostic tool.Acknowledgement of grants: This study was supported by the Ministry of Health, Czech Republic – Conceptual Development of Research Organization (FNOs/2024).

BackgroundHepatitis E virus (HEV) is a major cause of acute hepatitis worldwide. In the Czech Republic, genotype 3 predominates, transmitted mainly through undercooked meat. Reliable diagnostics are critical for detecting infections and assessing seroprevalence. Modern assays using recombinant HEV ORF2 proteins offer greater sensitivity than older methods. This study aimed to compare the performance of ELISA, immunoblot, and Elecsys anti-HEV IgM and IgG tests.MethodsEighty serum samples from organ and haematopoietic cell donors at the University Hospital Ostrava were analyzed. These samples, collected between 2022 and 2024, had tested positive for anti-HEV IgG or IgM using the Elecsys method (Roche Diagnostics). The assays evaluated included: Immunoblot recomLine HEV IgG/IgM (Mikrogen), ELISA recomWell HEV IgG/IgM (Mikrogen), HEV IgG/IgM ELISA (Wantai, DIA.PRO, Euroimmun). The Elecsys anti-HEV method served as the reference standard.ResultsFor anti-HEV IgG, the immunoblot recomLine test showed the highest concordance with ECLIA at 78.7% (63/80 samples). Among ELISA methods, recomWell (Mikrogen) had the best agreement at 48.7% (39/80), followed by Wantai (45.0%, 36/80), and Euroimmun (43.75%, 35/80). DIA.PRO showed the lowest concordance at 41.2% (33/80). For anti-HEV IgM, ECLIA detected three positive samples, and the immunoblot recomLine assay demonstrated 100% concordance. All ELISA methods were negative for anti-HEV IgM, indicating lower sensitivity compared to ECLIA.ConclusionsECLIA demonstrated the highest sensitivity and reliability for HEV diagnostics, making it the most suitable method for clinical use. The immunoblot recomLine test showed good concordance and is useful for confirmatory testing. However, ELISA methods showed limited sensitivity, particularly for IgM detection. For accurate diagnosis and reliable seroprevalence studies, ECLIA is strongly recommended as the primary diagnostic tool.Acknowledgement of grants: This study was supported by the Ministry of Health, Czech Republic – Conceptual Development of Research Organization (FNOs/2024).