FDA approves first rapid diagnostic test to detect HIV-1 antigen, HIV-1/2 antibodies

August 9, 2013

FDA has approved the first rapid Human Immunodeficiency Virus (HIV) test for the simultaneous detection of 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 Alere Determine HIV-1/2 Ag/Ab Combo, Orgenics, Ltd. (an Alere, Inc. company) was approved.

FDA has approved the first rapid Human Immunodeficiency Virus (HIV) test for the simultaneous detection of 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 Alere Determine HIV-1/2 Ag/Ab Combo, Orgenics, Ltd. [an Alere, Inc. company]) was approved.

Approved for use as an aid in the diagnosis of HIV-1 and HIV-2 infection, this test is also the first FDA-approved test that independently distinguishes results for HIV-1 p24 antigen and HIV antibodies in a single test.

“[This approval] can be viewed as another landmark approval that will aid in the earlier identification/detection and subsequent initiation of appropriate antiretroviral drug treatment in individuals with a confirmed diagnosis,” said Formulary advisor Abimbola Farinde, PharmD, MS, clinical staff pharmacist at Clear Lake Regional Medical Center, Webster, Texas. “Through early detention and treatment, the rates of HIV infection could also be reduced over time.”

Trained professionals in outreach settings can use this test to identify HIV-infected patients who might not be able to be tested in traditional healthcare settings. However, the test does not distinguish between antibodies to HIV-1 and HIV-2, and is not intended to be used for screening of blood donors.

Detection of HIV-1 antigen permits earlier detection of HIV-1 infection than is possible by testing for HIV-1 antibodies alone. The test can distinguish acute HIV-1 infection from established HIV-1 infection when the blood specimen is positive for HIV-1 p24 antigen but is negative for HIV-1 and HIV-2 antibodies.

HIV infection can result in the development of Acquired Immune Deficiency Syndrome, or AIDS. HIV damages the body’s defense mechanisms by destroying specific blood cells, called CD4+ T cells, which are crucial to helping the body fight diseases. Two types of HIV have been identified, HIV-1 and HIV-2. HIV-1 is responsible for most HIV infections throughout the world. HIV-2 is found primarily in West Africa; however, cases of HIV-2 infection have been reported in North America and Europe.

The Centers for Disease Control and Prevention estimates that each year approximately 50,000 people are infected with HIV in the United States. Of the more than 1 million people living with HIV in the United States, approximately 20% of those people have not been diagnosed.