To the Editor.—
The recent emphasis on the operating characteristics of the enzyme-linked immunosorbent assay (ELISA) human T-cell lymphotropic virus type III (HTLV-III) antibody test1-3 and its role as a screening mechanism for the acquired immunodeficiency syndrome (AIDS) presents us with a crucial problem. We fail to see how the sensitivity and/or specificity of a screening test for an infectious disease can be precisely defined in the absence of either data on the true prevalence of infection within a population or a "gold-standard" confirmatory test to identify infection. To date, it seems that the operating characteristics of the HTLV-III ELISA antibody test have been defined (1) on the assumption that antibody seropositivity is a quantitative, predictive measure for viremia; (2) primarily among clinical populations; and (3) assuming, for the most part, the ELISA test itself as the most sensitive available. This is not to say that the HTLV-III antibody
James JJ, Morgenstern MA. HTLV-III Antibodies in US Army Blood Donors in West Germany. JAMA. 1985;254(11):1449. doi:10.1001/jama.1985.03360110039010
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