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Laboratory and Epidemiologic Evaluation of an Enzyme Immunoassay for Antibodies to HTLV-III

John W. Ward, MD; Alfred J. Grindon, MD; Paul M. Feorino, PhD; Charles Schable, MS; Michael Parvin, MT; James R. Allen, MD, MPH
JAMA. 1986;256(3):357-361. doi:10.1001/jama.1986.03380030059028.
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The enzyme immunoassays (ElAs) for antibody to human T-cell lymphotropic virus type III (HTLV-III) were rapidly adopted for screening donated blood and plasma. To evaluate the significance of a positive EIA reaction, test performance was examined in a blood bank screening program. Specimens were tested by EIA, Western blot assay, and HTLV-III/ lymphadenopathyassociated virus (LAV) culture. The EIA was positive in 0.25% of 67 190 blood donations. Specimens were categorized and 57.3% had low (weak) reactivity, 12.7% had moderate reactivity, and 30.0% had high reactivity. Highly reactive specimens were strongly associated with a positive Western blot or culture (86.7%) in contrast to moderately and weakly reactive specimens (1.9%). Twenty-five of 29 donors interviewed with a highly reactive EIA had risk factors for HTLV-III/LAV infection. Risk factors were not identified for 74 of 75 interviewed donors with specimens of lower reactivity. The minimum calculated specificity was 99.82%. The use of the HTLV-III EIA has virtually eliminated the use of blood and plasma from HTLV-III/LAV infected donors.

(JAMA 1986;256:357-361)


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