New 20-Minute Combination HIV Test Now Available
A new rapid HIV test that can detect both early and established infection is now available to health care facilities and labs across the United States. The Determine HIV 1/2 Ag/Ab Combo, made by Alere, Inc., detects both human antibodies against HIV and an antigen produced by the virus itself, which shows up in blood tests earlier than antibodies. The combination test was approved by the U.S. Food and Drug Administration in August.
Detecting HIV infection during the early “acute” phase—before standard antibody tests can offer reliable results—may help newly diagnosed people seek treatment and care sooner and preserve immune function, as well as avoid inadvertently transmitting the virus to others. A growing body of research suggests that starting treatment soon after infection can help preserve immune function and boost health—and perhaps even factor into curing HIV infection.
As yet, the combo test is available only to facilities that are “licensed to conduct tests of moderate complexity.” The company is pursuing a waiver of this restriction, a press release states, so the new rapid test can be made available more broadly in clinics, doctors’ offices, and other HIV testing locations.
The Alere press release is excerpted below and available for download.
Alere Determine™ HIV 1/2 Ag/Ab Combo can detect HIV earlier than second and third generation antibody-only tests
WALTHAM, Mass., Oct. 29, 2013 — /PRNewswire/ — Alere Inc. (NYSE: ALR), the world’s leading provider of point-of-care rapid diagnostic and health information solutions, today announced the immediate U.S. availability of the Alere Determine™ HIV-1/2 Ag/Ab Combo test, the first U.S. Food and Drug Administration (FDA) approved rapid point-of-care test that detects both HIV-1/2 antibodies and the HIV-1 p24 antigen, which can appear days after infection and prior to HIV-1/2 antibodies.
“We’re excited to announce the availability of the only fourth generation rapid test that can identify HIV infections in individuals earlier than ever before at the point of care by detecting the free HIV-1 p24 antigen,” said Joe Medeiros, Director of Marketing, North America Virology Solutions at Alere. “The availability of the Alere Determine Combo test will contribute measurably to public health by helping HIV-positive individuals to become aware of their HIV status earlier, thereby potentially reducing HIV transmission. Earlier diagnosis can also allow effective treatment to be started without delay.”
The Alere Determine HIV-1/2 Ag/Ab Combo test is FDA-approved to be sold in the United States as a CLIA (Clinical Laboratory Improvement Amendments) moderately complex medical device. The test simultaneously detects free HIV-1 p24 antigen as well as antibodies to both HIV-1 and HIV-2 in human serum, plasma, and venous or fingerstick whole blood specimens. The test can be used by trained professionals in healthcare settings to identify HIV-infected individuals….