Sensitivity and specificity of commercially available rapid diagnostic tests for viral hepatitis B and C screening in serum samples

PLoS One. 2020 Jul 15;15(7):e0235036. doi: 10.1371/journal.pone.0235036. eCollection 2020.

Abstract

Early diagnosis of chronic hepatitis B virus (HBV) and hepatitis C virus (HCV) infections is pivotal for optimal disease management. Sensitivity and specificity of 19 rapid diagnostic test (RDT) kits by different manufacturers (ABON, CTK Biotech, Cypress Diagnostics, Green Gross, Human Diagnostic, Humasis, InTec, OraSure, SD Bioline, Wondfo) were assessed on serum samples of 270 Mongolians (90 seropositive for hepatitis B surface antigen (HBsAg), 90 seropositive for hepatitis C antibody (HCV-Ab), 90 healthy subjects). All tested RDTs for detection of HBsAg performed with average sensitivities and specificities of 100% and 99%, respectively. Albeit, overall sensitivity and specificity of RDTs for detection of HCV-Ab was somewhat lower compared to that of HBsAg RDTs (average sensitivity 98.9%, average specificity 96.7%). Specificity of RDTs for detection of HCV-Ab was dramatically lower among HBsAg positive individuals, who were 10.2 times more likely to show false positive test results. The results of our prospective study demonstrate that inexpensive, easy to handle RDTs are a promising tool in effective HBV- and HCV-screening especially in resource-limited settings.

Publication types

  • Comparative Study

MeSH terms

  • Adolescent
  • Adult
  • Aged
  • Female
  • Hepatitis B / diagnosis*
  • Hepatitis B Surface Antigens / blood
  • Hepatitis C / diagnosis*
  • Hepatitis C Antibodies / blood
  • Humans
  • Male
  • Mass Screening / economics
  • Mass Screening / methods*
  • Middle Aged
  • Prospective Studies
  • Reagent Kits, Diagnostic / standards*
  • Sensitivity and Specificity

Substances

  • Hepatitis B Surface Antigens
  • Hepatitis C Antibodies
  • Reagent Kits, Diagnostic

Associated data

  • figshare/10.6084/m9.figshare.9724157

Grant support

The author(s) received no specific funding for this work.