Evaluation of a new rapid test for the combined detection of hepatitis B virus surface antigen and hepatitis B virus e antigen

J Clin Microbiol. 2002 Dec;40(12):4603-6. doi: 10.1128/JCM.40.12.4603-4606.2002.

Abstract

There are about 350 million chronic hepatitis B virus (HBV) carriers worldwide. A proactive approach to the management of this disease is likely to reduce the morbidity and mortality caused by HBV. This study aimed to evaluate the diagnostic performance of a novel tool for discriminating between infected and noninfected subjects, the hepatitis B sAg/eAg test (Binax Inc., Portland, Maine). The test is designed to rapidly and accurately detect both the HBV surface antigen (HBsAg) and the HBV e antigen (HBeAg). A cohort of 942 subjects was tested. The serum clinical sensitivity of the hepatitis B sAg/eAg test was 99.75 and 96.37% for HBsAg and HBeAg, respectively. Serum clinical specificity was 99.32% for HBsAg and 98.99% for HBeAg. Analytical sensitivity was satisfactory for the purposes of population screening. Visual evaluation showed that the test signals were stable for at least 3 h after the recommended evaluation time. No interference or cross-reactivity was observed with known interfering substances and virologic markers. These results indicate that the hepatitis B sAg/eAg test is well suited to the accurate detection of HBV carriers. In addition to the good clinical specificity and sensitivity of this test, its stability and user-friendly design mean that a correct performance, even under field conditions, is highly likely. Consequently, the hepatitis B sAg/eAg test has the potential to identify subjects who require HBV vaccination (HBsAg(-) and HBeAg(-)) and HBV-infected individuals who might benefit most from antiviral therapy (HBsAg(+) and HBeAg(+)).

Publication types

  • Evaluation Study

MeSH terms

  • Carrier State / diagnosis*
  • Carrier State / virology
  • Hepatitis B Surface Antigens / blood*
  • Hepatitis B e Antigens / blood*
  • Hepatitis B virus / isolation & purification*
  • Hepatitis B, Chronic / diagnosis*
  • Hepatitis B, Chronic / virology
  • Humans
  • Reagent Kits, Diagnostic
  • Sensitivity and Specificity
  • Time Factors

Substances

  • Hepatitis B Surface Antigens
  • Hepatitis B e Antigens
  • Reagent Kits, Diagnostic