title: Performance characteristics of serologic tests for human immunodeficiency virus type 1 (HIV-1) antibody among Minnesota blood donors. Public health and clinical implications.
abstract: 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.
  
  
  METHODS
  Three-year prospective study of a selected sample from a community-based population.
  
  
  METHODS
  Two blood collection facilities in Minnesota.
  
  
  METHODS
  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.
authors.affiliation: Minnesota Department of Health.
authors.forename: K L
authors.initials: KL
authors.lastname: MacDonald
authors.forename: J B
authors.initials: JB
authors.lastname: Jackson
authors.forename: R J
authors.initials: RJ
authors.lastname: Bowman
authors.forename: H F
authors.initials: HF
authors.lastname: Polesky
authors.forename: F S
authors.initials: FS
authors.lastname: Rhame
authors.forename: H H
authors.initials: HH
authors.lastname: Balfour
authors.forename: M T
authors.initials: MT
authors.lastname: Osterholm
mesh_terms: D015492:AIDS Serodiagnosis / Q000379:methods*; D000328:Adult; D001782:Blood Donors; D015153:Blotting, Western; D005260:Female; D015483:HIV Antibodies / Q000032:analysis*; D015497:HIV-1 / Q000276:immunology* / Q000302:isolation & purification; D006801:Humans; D007124:Immunoenzyme Techniques; D008297:Male; D008910:Minnesota; D011237:Predictive Value of Tests; D011446:Prospective Studies
chemical_list: D015483:HIV Antibodies