Background: Hepatitis E virus (HEV) infection screening and diagnosis are critical for controlling the HEV epidemic. Serological testing for anti-HEV IgM and IgG is widely used to diagnose acute and past HEV infections, respectively. This study aims to evaluate the analytical performances of the MAGLUMI HEV IgM and IgG assays for detection of HEV antibodies and comparison with the microplate Wantai assay.
Methods: We assessed the precision, cross-reactivity, and interference of the MAGLUMI HEV IgM and IgG assays, as well as their agreement rates with the Wantai HEV IgM and IgG assays. Method comparison included in total 775 samples from 405 patients with suspected HEV infection and 86 asymptomatic blood donors. Among them, the HEV infection status of 136 individuals was confirmed through HEV RNA results, including 39 cases of acute infection, 3 cases of convalescence, and 94 cases of non-infected individuals.
Results: The within-run and between-day imprecision for the MAGLUMI HEV IgM assay ranged from 1.54% to 3.71%, while for the MAGLUMI HEV IgG assay, it ranged from 0.00% to 4.35%. No cross-reactivity was observed in either assay. The positive and negative agreement rates between the MAGLUMI and Wantai IgM assay were 98.61% and 99.31%, respectively. The positive and negative agreement rates between the MAGLUMI and Wantai IgG assay were 94.95% and 97.20%, respectively.
Conclusions: Overall, the analytical performance of the MAGLUMI HEV IgM and IgG assays is good, with reactivities comparable to those of the Wantai HEV IgM and IgG assays. However, due to the limited availability of HEV RNA detection results and lack of HEV genotype information, this study could not effectively evaluate the clinical performance of the reagent, and further studies with HEV RNA determination and genotyping are needed for a clinical validation.
Keywords: Chemiluminescence immunoassay; Diagnosis; HEV IgG; HEV IgM; Hepatitis E virus; MAGLUMI.
© 2026. The Author(s).