Kristine L. MacDonald, MD; J. Brooks Jackson, MD; Robert J. Bowman, MD; Herbert F. Polesky, MD; Frank S. Rhame, MD; Henry H. Balfour Jr, MD; Michael T. Osterholm, PhD, MPH
Study Objective: To evaluate performance characteristics of sequential enzyme immunoassay (EIA) and Western blot human immunodeficiency virus type 1 (HIV-1) antibody testing in a low-risk population.
Design: Three-year prospective study of a selected sample from a community-based population.
Setting: Two blood collection facilities in Minnesota.
Population: Minnesota blood donors.
Results: During the study period, 630 190 units of blood (donations) from an estimated 290 110 Minnesota-resident donors were screened for HIV-1 antibody. Seventeen Minnesota-resident donors were identified as positive for HIV-1 antibody. Sixteen donors were available for follow-up HIV-1 culture: all were culture positive. The other donor, who was not available for follow-up culture, was likely infected with HIV-1 based on a history of high-risk behavior and positive serologic findings for hepatitis B surface antigen. Using 95% binomial confidence intervals, performance characteristics for sequential EIA and Western blot HIV-1 antibody serology were as follows: false-positive rate by number of donations, 0% to 0. 0006%; specificity by number of donations, 99.9994% to 100%; predictive value of a positive test, 81% to 100%.
Conclusions: In this low-risk population, the false-positive rate of serologic tests for HIV-1 antibody, using HIV-1 culture as the definitive standard for infection status, was extremely low and test specificity was extremely high.
MacDonald KL, Jackson JB, Bowman RJ, et al. Performance Characteristics of Serologic Tests for Human Immunodeficiency Virus Type 1 (HIV-1) Antibody among Minnesota Blood Donors: Public Health and Clinical Implications. Ann Intern Med. 1989;110:617–621. doi: https://doi.org/10.7326/0003-4819-110-8-617
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Published: Ann Intern Med. 1989;110(8):617-621.
HIV, Infectious Disease.
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