Diagnostic utility of hepatitis E virus antigen-specific ELISA versus PCR testing in a cohort of post liver transplant patients in a large university hospital

作者：Soothill G^*; Hessey S; Erotocritou M; Griffiths P; Ijaz S; Thorburn D; Ankcorn M; Irish D

来源：Journal of Clinical Virology, 2018, 106: 44-48.

DOI：10.1016/j.jcv.2018.07.007

• Hepatitis E virus
• Antigen-specific ELISA
• Liver transplant patients
• Screening
• Positive predictive value
• Negative predictive value

Background: Hepatitis E virus (HEV) is an important infectious agent causing acute and chronic disease. Chronic hepatitis E affects immunocompromised people and serological testing is neither reliable nor sufficient to infer whether a patient has infection; therefore HEV RNA testing is the only reliable diagnostic test presently available. An HEV antigen-specific ELISA test is commercially available but is not yet in clinical use.
Objectives: 1) determine the prevalence of HEV infection in the Royal Free Hospital (RFH) liver transplant cohort; 2) compare the diagnostic utility of HEV antigen-detection against the current gold standard; 3) consider screening strategies for HEV infection in immunocompromised groups.
Study design: The serum samples of 490 post liver transplant patients visiting the outpatient clinic at the RFH over an eight-month period were tested for HEV with both an HEV antigen-specific ELISA and HEV RNA test.
Results: The prevalence of HEV infection was 0.20% (95% CI 0.0%-1.1%). The specificity of the ELISA was 98.2% with a positive predictive value of 10.0%. There was one true positive HEV case, which was picked up correctly by the antigen-specific ELISA. These results were improved by incorporating a neutralisation step into further ELISA tests.
Conclusions: The antigen-specific ELISA test gave no false negative results, supporting its utility as a screening tool. There was one true antigen positive result. Further investigation including cost analysis is indicated to determine the efficacy of HEV antigen-specific ELISA testing in a screening context and in the clinical investigation of HEV infection in immunocompromised patients.

• 出版日期2018-9