The first rapid test for HIV that detects viral antigens as well as antibodies to the virus has received green signal from Food and Drug Administration (FDA).
The pioneering rapid HIV test has the ability to simultaneously detect HIV-1 p24 antigen as well as antibodies to both HIV Type 1 and Type 2. This will help in earlier detection of HIV infection that is possible with purely serological tests, according to the FDA.
“This test helps diagnose HIV infection at an earlier time in outreach settings, allowing individuals to seek medical care at an early stage,” the FDA statement reads.
The test is a remarkable development in the medical field as earlier diagnosis of these deadly viruses may also help to reduce additional HIV transmission. The advantages of this test have huge implications for combating AIDS in sub-Saharan Africa and other underdeveloped areas of the world.
The test may be used with serum, plasma, or venous or fingerstick whole blood samples and can be used in remote locations “to identify HIV-infected individuals who might not be able to be tested in traditional health care settings,” the statement reads.
By detecting a viral antigen along with anti-HIV antibodies, the test can distinguish new from established HIV-1 infections, the FDA noted.
The FDA cautioned that the test does not distinguish between antibodies to HIV-1 and HIV-2, and that it is not suitable for screening potential blood donors.
HIV infection further leads to deadly disease called AIDS (Acquired Immune Deficiency Syndrome) which damages natural defense mechanisms of the human body by destroying CD4+ T cells. It is a type of white blood cell which helps the body fight diseases.
The American Centers for Disease Control and Prevention estimates that each year around 50,000 people are infected with HIV in the US.