In two separate moves, the FDA has approved the first assay to detect both antigen and antibodies to HIV and the first rapid blood test for hepatitis C virus (HCV) antibodies.
The Architect HIV Ag/Ab Combo assay is approved for the diagnosis of HIV-1/HIV-2 infection in adults, including pregnant women. It is also the first assay for use as an aid in HIV-1/HIV-2 diagnosis in children as young as age 2 years. Most diagnostic tests detect HIV antibodies only; this assay also can diagnose infection at an earlier stage—prior to the emergence of antibodies—because it can detect the HIV-1 p24 antigen.
On the HCV front, the new OraQuick HCV Rapid Antibody Test does not require an instrument for diagnosis. The test strip yields results in approximately 20 minutes, meaning more patients can be notified of their HCV infection faster and seek treatment sooner, according to a statement announcing the test’s approval.
The OraQuick test is approved for use only in people at risk for HCV infection or those with suspected hepatitis and is not intended for general-population screening purposes.