Performance of rapid diagnostic tests for hepatitis B surface antigen detection in serum or plasma

Diagn Microbiol Infect Dis. 2021 Jun;100(2):115353. doi: 10.1016/j.diagmicrobio.2021.115353. Epub 2021 Feb 17.

Abstract

Hepatitis B surface antigen (HBsAg) is a key marker for screening and laboratory diagnosis of HBV infection. Rapid diagnostic tests (RDTs) represent promising alternatives to immunoassay-based methods because they are simple, fast and cheap. These tests, therefore, represent a powerful tool for large-scale screening and diagnosis of HBV infection in the clinical setting. Performance of 6 RDTs have been assessed in a large series of serum or plasma samples (n = 501) collected in France and in Cameroon. Specificity varied from 98.0% to 99.5%, while clinical sensitivity, compared to immunoassays as the reference, was excellent for all six RDTs (98.3%-99.3%). The VIKIA HBsAg and First Response HBsAg Card Test reached sensitivity ≥99%. False-negative results were rare and mostly encompassed inactive HBsAg carriers or patients treated with nucleoside/nucleotide analogues. A number of RDTs may widely use to increase access to testing to all levels of the health care system.

Keywords: Rapid diagnostic test; diagnosis; hepatitis B surface antigen; hepatitis B virus; screening.

Publication types

  • Multicenter Study

MeSH terms

  • Cameroon / epidemiology
  • Case-Control Studies
  • Diagnostic Tests, Routine / methods*
  • France / epidemiology
  • Hepatitis B / blood*
  • Hepatitis B / diagnosis*
  • Hepatitis B / epidemiology
  • Hepatitis B Surface Antigens / blood*
  • Humans
  • Immunoenzyme Techniques
  • Sensitivity and Specificity
  • Serologic Tests / methods*

Substances

  • Hepatitis B Surface Antigens