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The U.S. Food and Drug Administration today 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.
Approved for use as an aid in the diagnosis of HIV-1
and HIV-2 infection, the Alere Determine HIV-1/2 Ag/Ab
Combo test is also the first FDA-approved test that
independently distinguishes results for HIV-1 p24
antigen and HIV antibodies in a single test.
The test can be used by trained professionalsin
outreach settings to identify HIV-infected
individuals who might not be able to be tested in
traditional health care settings.
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.
“This test helps diagnose HIV infection at an
earlier time in outreach settings, allowing
individuals to seek medical care sooner,” said Karen
Midthun, M.D., director of the FDA’s Center for
Biologics Evaluation and Research. “Earlier
diagnosis may also help to reduce additional HIV
transmission.”
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 percent of those
people have not been diagnosed.
For more information
U.S. Food and Drug Administration
MDN
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