TECHNOLOGY for detecting the antibody to human immunodeficiency virus type 1 (HIV-1), the etiologic agent of the acquired immunodeficiency syndrome (AIDS), was first licensed by the Food and Drug Administration (FDA) in 1985. Since then, the spread of the AIDS epidemic from subpopulations, such as male homosexuals, drug abusers sharing contaminated needles, and female prostitutes, to other people with less obvious risk factors has underscored the need for accurate testing to detect infection with HIV-1. The appreciation that people who test positive for HIV-1 can infect others1,2 and the demonstration that infected individuals can benefit from early detection and treatment3-5 have further accentuated this need. Although the first test developed was extremely effective in detecting HIV-1 in patients with AIDS, developing tests for screening healthy people has presented a different challenge. A test that could detect small amounts of HIV-1 early in asymptomatic persons and a confirmatory test
Sloand EM, Pitt E, Chiarello RJ, Nemo GJ. HIV Testing: State of the Art. JAMA. 1991;266(20):2861–2866. doi:10.1001/jama.1991.03470200073038
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