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Calibrating Hepatitis E Virus Serological Assays Using Asymptomatic Specimens Obtained in Japan
Kazutaka Terahara1, Tian-Cheng Li2, Keiji Matsubayashi3
1Research Center for Drug and Vaccine Development, National Institute of Infectious Diseasesgrid.410795.e, Tokyo, Japan.
Microbiology Spectrum
|September 20, 2022
Summary
Optimizing hepatitis E virus (HEV) antibody assays is crucial for accurate diagnosis. An in-house enzyme-linked immunosorbent assay (ELISA) demonstrated higher sensitivity for HEV IgM, IgA, and IgG detection, especially in asymptomatic individuals, compared to commercial kits.
Area of Science:
- Virology and Immunology
- Diagnostic Assay Development
- Public Health Surveillance
Background:
- Accurate diagnosis of hepatitis E virus (HEV) infection is vital for public health and transfusion safety.
- Existing commercial serological assays for HEV antibodies exhibit significant variability in sensitivity and specificity.
- No HEV antibody detection methods are currently FDA-approved, highlighting a need for improved diagnostic tools.
Purpose of the Study:
- To calibrate and optimize in-house and commercial hepatitis E virus (HEV) serological assays.
- To compare the performance of an in-house HEV antibody enzyme-linked immunosorbent assay (ELISA) against commercial kits.
- To identify key factors for improving the accuracy of HEV serological diagnostics.
Main Methods:
- Optimization of an in-house HEV antibody ELISA by establishing cutoffs using a serological performance panel.
- Subtraction of nonspecific background values for anti-HEV IgM, IgA, and IgG.
- Comparative analysis of the in-house ELISA against commercial IgM, IgA, and IgG assay kits using symptomatic, asymptomatic, and seroconversion panels.
Main Results:
- The in-house ELISA demonstrated superior sensitivity for detecting HEV IgM, IgA, and IgG compared to commercial kits, particularly in asymptomatic individuals.
- The in-house assay detected HEV IgM and IgG seroconversion earlier than commercial kits.
- High cutoff values in commercial kits contributed to low sensitivity, while background subtraction was essential for maintaining high specificity in the in-house assay.
Conclusions:
- Asymptomatic specimens and background subtraction are critical for optimizing HEV serological assays.
- The in-house ELISA offers a more sensitive alternative for detecting HEV IgM and IgA than currently available commercial kits.
- Optimizing cutoffs and reducing background noise could improve the performance of commercial HEV antibody detection kits.
