Immunoassay Uses Oral Fluid to Assess Hepatitis E Infection

HealthDay News —  A noninvasive oral fluid-based immunoassay has high sensitivity and specificity for identifying recent and past hepatitis E virus (HEV) infection, according to a study published in the Journal of Immunological Methods.

Nora Pisanic, PhD, from the Johns Hopkins Bloomberg School of Public Health in Baltimore, developed an immunoassay that uses oral fluid to assess past and recent HEV infection. The assay was validated using paired oral fluid and serum samples collected from 141 patients with or without symptoms of acute viral hepatitis (76 and 65 patients, respectively). The authors calculated the sensitivity and specificity of the oral fluid-based immunoassay for HEV immunoglobulin (Ig)G (past HEV infection) and HEV IgA (recent HEV infection) antibodies, relative to Wantai’s serum-based HEV enzyme-linked immunosorbent assay (ELISA) for IgG and IgM.

The researchers found that the sensitivity of the oral fluid-based immunoassay for HEV-IgG antibodies was 98.7% and the specificity was 98.4%. For HEV IgA, the sensitivity and specificity were 89.5% and 98.3%, respectively.

“The high concordance of our non-invasive oral fluid-based immunoassays (HEV IgG and HEV IgA) with commercial high-performance serum HEV ELISA kits (IgG and IgM) means that population-based surveillance of past and recent HEV infection could be expanded to improve understanding of its ecology and natural history,” the authors write.

Two authors disclosed ties to Salimetrics; one disclosed ties to SalivaBio.

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Pisanic N, Rahman A, Saha SK, et al. Development of an oral fluid immunoassay to assess past and recent hepatitis E virus (HEV) infection. J Immunol Methods. 2017 May 3. pii: S0022-1759(17)30009-1. doi: 10.1016/j.jim.2017.04.012.