Orgenics, a subsidiary of Alere, has received the US Food and Drug Administration (FDA) approval for its rapid diagnostic test that can simultaneously detect HIV-1 p24 antigen and antibodies to both HIV-1 and HIV-2 in human serum, plasma and venous or fingerstick blood samples.
The Alere Determine HIV-1/2 Ag/Ab Combo test is also claimed to be first FDA-cleared diagnostic test that can differentiate the results for HIV-1 p24 antigen and HIV antibodies right in a single test.
It can be used in an outreach environment to identify HIV-infected individuals, who otherwise may not find it feasible to get tested in a conventional traditional health care setting.
With the detection of HIV-1 antigen, HIV-1 infection can be identified much earlier than is currently possible through the testing for HIV-1 antibodies alone.
In addition, the test can differentiate acute and established HIV-1 infections when the blood sample turns positive for HIV-1 p24 antigen, but is negative for HIV-1 and 2 antibodies.
FDA's Center for Biologics Evaluation and Research director Dr Karen Midthun said this test helped diagnose HIV infection at an earlier time in outreach settings, allowing individuals to seek medical care sooner.
"Earlier diagnosis may also help to reduce additional HIV transmission," Midthun said.
However, this test does not distinguish between antibodies to HIV-1 and HIV-2, and is not also meant for screening of blood donors, the regulatory agency cautioned.
HIV infection leads to the development of acquired immune deficiency syndrome (AIDS).
HIV destroys specific blood cells, called CD4+ T, which are necessary to aid the body in fighting infections and diseases.
There are two types of HIVs. HIV-1, which is responsible for most HIV infections worldover; and HIV-2, mostly reported in West Africa though cases have been found in North America and Europe.
According to the Centers for Disease Control and Prevention, every year around 50,000 people are infected with HIV in the US alone. Of more than one million people in the US living with this infection, 20% have not been diagnosed.