CAP TODAY Pathology/Laboratory Medicine/Laboratory Management
Alere has received FDA approval to market its Alere Determine HIV-1/2 Ag/Ab Combo in the United States.
The Alere Determine HIV-1/2 Ag/Ab Combo is a rapid point-of-care test that detects both HIV-1/2 antibodies and the HIV-1 p24 antigen, which can appear days after infection and prior to HIV-1/2 antibodies.
The FDA approval allows Alere to market the test, which can help identify additional cases that would not be detected using second- and third-generation antibody-only tests, as a CLIA moderately complex medical device.
Alere, 877-441-7440