ELISA test

In March 1985, the FDA approves the enzyme-linked immunosorbent assay (ELISA), a test that detects antibodies of HIV (then known as HTLV-III). Originally developed to screen the blood supply for HIV, it is also used to screen for HIV in individuals. But the ELISA is highly sensitive and often produces false positives. This may be adequate for blood supply screening, but for HIV diagnosis in people the results can be devastating. At the time, the test has a label which reads: “It is inappropriate to use this test as a screen for AIDS or as a screen for members of groups at increased risk for AIDS in the general population. The presence of HTVL-III [now HIV] antibody is NOT a diagnosis of AIDS.” It is not until 1987, when the Western Blot test is approved, that HIV diagnosis becomes more reliable.