Abbott gets clearance for p24 antigen test
This article was originally published in Clinica
Executive Summary
Abbott Laboratories has received US FDA clearance to market HIVAG-1 Monoclonal, its HIV-1 p24 antigen test. The assay, which detects the virus directly, is intended for detecting infection before seroconversion has taken place. It was cleared for both blood-bank screening and prognostic use in HIV-infected patients. The FDA approved Coulter's p24 test in March (see Clinica No 697, p 16).