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Hepatitis E virus serology and PCR: does the methodology matter?
Lien Cattoir1, Frederik Van Hoecke1, Tom Van Maerken1
1Department of Clinical Chemistry, Microbiology and Immunology, Ghent University Hospital, De Pintelaan 185, 2P8, 9000, Ghent, Belgium.
Archives of Virology
|May 20, 2017
Summary
Accurate diagnosis of Hepatitis E virus (HEV) genotype 3 infection is challenging due to non-specific symptoms. This study found significant performance differences in serological and PCR assays, urging cautious interpretation of HEV test results.
Area of Science:
- Virology
- Infectious Diseases
- Diagnostic Medicine
Background:
- Hepatitis E virus (HEV) genotype 3 is an emerging pathogen in developed countries.
- Clinical presentation and routine lab tests for HEV are often non-specific, necessitating reliable diagnostic methods.
- Accurate diagnostic tests are crucial for timely and effective patient management.
Purpose of the Study:
- To evaluate the performance of various serological and PCR assays for detecting HEV genotype 3.
- To compare the accuracy and reliability of different commercial and in-house diagnostic kits.
- To highlight the variability in HEV diagnostic test performance.
Main Methods:
- Evaluation of six commercial HEV ELISA assays (IgM and IgG) from Biorex, Wantai, and Mikrogen.
- Detection of HEV RNA using one commercial (Altona RealStar®) and two in-house real-time RT-PCR assays.
- Testing of 70 patients with suspected HEV infection and 16 external quality control (EQC) samples.
Main Results:
- Seroprevalence varied: HEV IgM from 5.7% to 14.3%, and HEV IgG from 15.7% to 20.0% across different ELISA assays.
- PCR assays showed high agreement on clinical samples, but 10 out of 16 EQC samples revealed major discrepancies.
- Significant performance differences were observed among the evaluated serological and molecular assays.
Conclusions:
- There are considerable variations in the performance of commercially available and in-house HEV diagnostic assays.
- Results from both serological and molecular HEV tests should be interpreted with caution due to observed discrepancies.
- Further standardization and validation of HEV diagnostic tests are recommended for reliable clinical application.
