Validation of Whole Blood Rapid Diagnosis Test for Hepatitis B

Ann Glob Health. 2020 May 21;86(1):53. doi: 10.5334/aogh.2866.

Abstract

We recently published a report validating point-of-care rapid diagnostic tests (RDT) for the diagnosis of Hepatitis B virus (HBV) infection in serum. In the current report, we validated a whole-blood RDT for HBsAg in the form of a test-strip. The test was validated in 55 HBV positive individuals across all genotypes other than F, and in 20 HBV negative individuals in the Netherlands. The RDT showed 100% sensitivity and specificity. The low cost and use in whole blood allows this RDT to be useful in resource-limited locations, further validation in such settings will be of importance.

Publication types

  • Letter
  • Research Support, N.I.H., Extramural
  • Research Support, Non-U.S. Gov't
  • Validation Study

MeSH terms

  • Adolescent
  • Adult
  • Antiviral Agents / therapeutic use
  • Child
  • Child, Preschool
  • DNA, Viral / blood
  • Female
  • Hepatitis B Surface Antigens / blood*
  • Hepatitis B e Antigens / blood
  • Hepatitis B, Chronic / blood
  • Hepatitis B, Chronic / diagnosis*
  • Hepatitis B, Chronic / drug therapy
  • Humans
  • Male
  • Middle Aged
  • Reagent Kits, Diagnostic
  • Reproducibility of Results
  • Sensitivity and Specificity
  • Viral Load
  • Young Adult

Substances

  • Antiviral Agents
  • DNA, Viral
  • Hepatitis B Surface Antigens
  • Hepatitis B e Antigens
  • Reagent Kits, Diagnostic