FDA grants waiver for HIV test

The FDA has granted Alere a Clinical Laboratory Improvement Amendments waiver for its point-of-care rapid diagnostic test for HIV infection, according to a press release.

The Alere Determine HIV-1/2 Ag/Ab Combo test was approved by the FDA in August 2013. Until recently, it has been commercially available in the United States to health care facilities and laboratories licensed to conduct tests of moderate complexity. The CLIA waiver will now allow the test to be used in physician offices, clinics and other public health care settings.

The test is capable of detecting HIV-1 and HIV-2 antibodies and HIV p24 antigen, which can appear only days after infection and before the HIV antibody is detectable. As a result, the test may detect HIV infection earlier in the course of the disease, according to the manufacturer.

“The CLIA waiver of the Alere Determine HIV-1/2 Combo will help facilitate accurate and early detection of HIV, which is critical to stemming the spread of HIV/AIDS in the United States,” Avi Pelossof, global president of infectious diseases at Alere, said in the release.

According to the CDC, more than 1.2 million people aged 13 years or older are living with HIV in the US, and 14% are unaware of their infection.

“The promise of a fourth-generation, rapid HIV test is one that we all look forward to since it will allow screening locations to potentially identify early HIV infections, and to steer those who are most at risk of infecting others into treatment sooner,” Eugene G. Martin, PhD, professor of pathology and laboratory medicine at Robert Wood Johnson Medical School at Rutgers University and co-director of the New Jersey Rapid HIV Test Support Program, said in the release.