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Performance Characteristics of Serologic Tests for Human Immunodeficiency Virus Type 1 (HIV-1) Antibody among Minnesota Blood Donors: Public Health and Clinical Implications

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; and Michael T. Osterholm, PhD, MPH
[+] Article, Author, and Disclosure Information

Grant Support: Partial support by grant AI-27661 from the National Institute of Allergy and Infectious Disease.

Requests for Reprints: Kristine L. MacDonald, MD, Minnesota Department of Health, 717 Delaware Street Southeast, Minneapolis, MN 55440.

Current Author Addresses: Drs. MacDonald and Osterholm: Acute Disease Epidemiology Section, Minnesota Department of Health, Minneapolis, MN 55440.

Dr. Jackson: Department of Laboratory Medicine, University of Minnesota Medical School, Minneapolis, MN 55455 and the American Red Cross Blood Services, St. Paul Region, St. Paul, MN 55107.

Dr. Bowman: American Red Cross Blood Services, St. Paul Region, St. Paul, MN 55107.

Dr. Polesky: The Memorial Blood Center of Minneapolis, Minneapolis, MN 55404.

Drs. Rhame and Balfour: Department of Internal Medicine, and Departments of Laboratory Medicine and Pediatrics, University of Minnesota Medical School, Minneapolis, MN 55455.

©1989 American College of PhysiciansAmerican College of Physicians

Ann Intern Med. 1989;110(8):617-621. doi:10.7326/0003-4819-110-8-617
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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.





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