Access to the Alere Determine HIV-1/2 Ag/Ab Combo test, a fourth-generation rapid test, has expanded thanks to the FDA’s granting of a CLIA (Clinical Laboratory Improvement Amendments) Waiver. In August 2013, the test was approved for sale in the U.S. to health facilities and labs that are licensed to conduct tests of moderate complexity; now the test can be used in doctor’s offices, clinics, and other public-health settings.
As the first fourth-generation, rapid point-of-care test that can detect both HIV-1/2 antibodies and free HIV-1 p24 antigen, test results can be sped up. HIV-1 p24 shows up in a few days after infection, while HIV antibodies can take much longer to appear.
Dedicated to improving better clinical and economic healthcare outcomes around the world, Alere has a range of rapid diagnostic tests for infectious diseases, like HIV, cardiometabolic disease, and toxicology. The company is excited that this expanded access on the homefront will put a dent in the treatment cascade, which shows that 15.8 percent of the approximately 1.1 million Americans living with HIV do not know their status. Research has shown that early detection of HIV leads to improved health outcomes for individuals living with HIV/AIDS and that early treatment of HIV in the acute infection phase, when the virus is most infectious, will prevent infections.
“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,” said Avi Pelossof, Global President of Infectious Disease at Alere, in a prepared 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.”
For more information, visit www.AlereHIV.com/US.