FDA has granted CLIA waived status to the Alere Determine HIV-1/2 Ag/Ab Combo test from Alere, Waltham, Mass. The approval makes the test available for wider use in physician offices, clinics, and other public health settings. Approved by FDA in August 2013, the Determine HIV 1-2 Ag/Ab Combo is a fourth-generation, rapid point-of-care test that detects both HIV-1/2 antibodies and free HIV-1 p24 antigen. The p24 antigen typically appears within days following HIV infection and before the HIV antibody is detectable, enabling the Determine assay to more quickly diagnose patients and facilitate earlier treatment.
“CLIA waiver of the Alere Determine HIV-1/2 Ag/Ab Combo will help facilitate accurate and early detection of HIV, which is critical to stemming the spread of HIV/AIDS in the United States, and will have a positive economic impact by bringing a critical healthcare service nearer to patients,” says Avi Pelossof, global president of infectious disease at Alere. “Broadening the test’s availability to laboratories, physician offices, clinics, and other public health settings advances Alere’s commitment to delivering reliable and actionable information through rapid diagnostics.”
For more information, visit Alere.