OraQuick ADVANCE Rapid HIV-1/2 antibody test

Abstract

Rapid HIV antibody tests represent a key development in the current diagnosis and management of HIV infection. The OraQuick ADVANCE Rapid HIV-1/2 antibody test (OraSure Technologies) has received US Food and Drug Administration approval on the basis of its performance characteristics and a subsequent Clinical Laboratory Improvement Amendments waiver based on its simplicity and accuracy. The test has been approved for use on oral mucosal transudate, whole blood or plasma. Clinical evaluation of the OraQuick ADVANCE Rapid HIV-1/2 antibody test has revealed high sensitivity and specificity. The test has many important applications, extending the opportunities for voluntary counseling and testing, and as a tool for the scale-up of antiretroviral therapy in resource-limited settings.