The U.S. Food and Drug Administration (FDA) has granted permission for more widespread use of a rapid HIV test that can detect the virus earlier after infection than standard antibody tests. Approved by the FDA in August 2013, the Alere Determine HIV-1/2 Ag/Ab Combo test was initially only permitted for use inside health facilities and laboratories licensed to conduct tests that are of “moderate complexity.” The FDA has granted what is known as a Clinical Laboratory Improvement Amendments (CLIA) waiver for the test, allowing its use in venues such as doctors’ offices, clinics and testing vans.

The first “fourth generation” assay to receive a CLIA waiver, the Determine looks both for HIV antibodies and for what is known as the p24 antigen, a component of HIV that is detectable earlier than antibodies. The antigen appears as early as a few days after infection and by nature precedes antibodies because p24 prompts their emergence. So the test can cut down on the proportion of false negative results among people who were recently exposed to the virus.

Additionally, because p24 disappears again after a few weeks, only to reemerge during advanced AIDS, its presence can indicate a recent infection. This information can be useful for making treatment decisions.
“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,” Avi Pelossof, global president of infectious Disease at Alere, said in a press release. “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.”

“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 Martin, PhD, a professor of pathology and laboratory medicine at Rutgers University, said in the same press release.

To read the press release, click here.