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US approves first combined rapid antigen & antibody test

Friday, 9 August, 2013

The United States Food and Drug Administration (FDA) has approved the first rapid HIV test that detects both HIV-1 p24 antigens, and antibodies to HIV-1 or HIV-2. It is believed that a combined test of this kind will help to increase earlier HIV  diagnoses in the country, thereby enabling people to begin treatment as quickly as possible.

Antigens are a substance found on a foreign body or germ that trigger the production of antibodies. The antigen on HIV that most commonly provokes an antibody response is the protein p24. Early in HIV infection, p24 is produced in excess and can be detected in the blood serum (although as HIV becomes fully established in the body it will fade to undetectable levels).

The newly approved Alere Determine HIV-1/2 Ag/Ab Combo test simultaneously detects antigens and antibodies in human serum, plasma, and venous or fingerstick blood samples. This combined test allows for HIV-1 infection to be identified earlier than an HIV-1 antibody test. While combined tests of this kind are already in use in the US, the availability of a rapid test will ensure testing is easier and results are received much more quickly.