Abbott HTLV III EIA (Enzyme Immunoassay for the Detection of Antibody to Human T-Lymphotropic Virus Type III in Human Serum or Plasma)

Description:

On March 2, 1985, Abbott Laboratories of Chicago, Illinois received the first government license to produce a blood test designed to screen blood for exposure to the AIDS virus. The test, named ELISA or EIA (Enzyme-linked Immunosorbent Assay), did not diagnose AIDS, but instead detected antibodies produced by the body's immune system to fight HTLV-III (Human T-Lymphotropic Virus Type-3) which had been identified as the probable cause of AIDS.

About 2% of the over 8,000 cases of AIDS reported between 1981 and 1985 were linked to contaminated blood transfusions. With over 3 million individuals receiving transfusions each year, guaranteeing safe blood supplies became paramount for public health officials. In response, the government selected five drug companies to compete to produce a blood screening test and promised to expedite the licensing process. After Abbott Laboratories' success in March, 1985, the ELISA test was immediately put to use in blood collection centers around the country, and by the end of July the nation's blood supply was declared free of AIDS.

While officials grappled with questions of when and how to inform and counsel donors whose blood tested positive for the AIDS virus antibodies, more difficult concerns about the test arose. The test was often falsely positive, of little consequence when screening the blood supply but of serious consequence to the individual tested. Furthermore, the presence of antibodies alone did not mean a person would develop AIDS, or that they were even currently infected with the virus. Although officials stressed that test information would be kept strictly confidential, many people feared the misuse of information might lead to discrimination or social ostracism. The test proved especially controversial in the gay community that was most affected by AIDS.

For these reasons the government required the kit bear the label: "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 HTLV III antibody is NOT a diagnosis of AIDS." However, in popular understanding and practice, the ELISA test became the "AIDS test."

The test worked as follows: The kit contains a vial of resin beads coated with antigens (viral proteins) of HTLV-III, the AIDS virus. A blood sample is added. If antibodies to the virus are present in the blood sample they will "stick" to the antigen-coated beads. A chemical is added which then sticks to the antibodies if present, or is washed away if they are not. A second chemical is added which turns a yellow-orange color if the first chemical is present, indicating a positive test and the presence of AIDS virus antibodies in the blood sample.

In 1985 the first commercial HIV test became available. Using a technique developed in the 1960s and 1970s, the test identified HIV antibodies. It also sparked intense debates about privacy and the potential misuse of test results.