Rapid AIDS Test Licensed

FOOD AND DRUG ADMINISTRATION
T A L K P AU.S. Department of Health and Human Services
Public Health Service 5600 Fishers Lane Rockville, Maryland 20857
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full tests are releasable upon request.
T92-26 Karen Malone
May 27, 1992 [phone]
RAPID AIDS TEST LICENSED
FDA has licensed a 10-minute diagnostic test kit which can be used by
health professionals to detect the presence of Human Immunodeficiency Virus
Type-1 (HIV-1) -- the virus that causes AIDS. This new HIV-1 diagnostic kit
will quickly and reliably detect antibodies to HIV-1. It can be used in
doctors' offices, clinics, emergency rooms, small hospitals, laboratories or
other health care settings where traditional HIV diagnostic test kits are
impractical or unavailable.
The following may be used to answer questions:
The diagnostic test is a manually performed, 10-minute immunoassay to
detect antibodies to HIV-1 in human serum or plasma. It is performed by
mixing a small amount of a patient's serum or plasma with an antibody:reagent to which only HIV-1 antibodies will attach. When a special solution
is added to the serum or plasma plus a reagent mixture, the window at the
bottom of the test cartridge indicates the result. The enzyme turns blue if
the results indicate that antibodies to HIV-1 are present. As with other
screening tests, positive results must be confirmed by additional testing
with other licensed test kits such as the Western blot or iniunofluorescence

assay.
In clinical trials involving 8,714 specimens at 11 test sites, the
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