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Journal of Clinical Microbiology, December 2002, p. 4603-4606, Vol. 40, No. 12
0095-1137/02/$04.00+0     DOI: 10.1128/JCM.40.12.4603-4606.2002
Copyright © 2002, American Society for Microbiology. All Rights Reserved.

Evaluation of a New Rapid Test for the Combined Detection of Hepatitis B Virus Surface Antigen and Hepatitis B Virus e Antigen

F. Clement, P. Dewint, and G. Leroux-Roels^*

Center for Vaccinology, Ghent University and Hospital, B-9000 Ghent, Belgium

Received 20 May 2002/ Returned for modification 29 July 2002/ Accepted 13 September 2002

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⁺).

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* Corresponding author. Mailing address: Center for Vaccinology, Ghent University and Hospital, De Pintelaan 185, B-9000 Ghent, Belgium. Phone: 32 9 240 34 22. Fax: 32 9 240 63 11. E-mail: geert.lerouxroels{at}rug.ac.be.

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Journal of Clinical Microbiology, December 2002, p. 4603-4606, Vol. 40, No. 12
0095-1137/02/$04.00+0     DOI: 10.1128/JCM.40.12.4603-4606.2002
Copyright © 2002, American Society for Microbiology. All Rights Reserved.

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