Performance characteristics of serologic tests for human immunodeficiency virus type 1 (HIV-1) antibody among Minnesota blood donors. Public health and clinical implications.
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.
MacDonald
K L
KL
Minnesota Department of Health.
Jackson
J B
JB
Bowman
R J
RJ
Polesky
H F
HF
Rhame
F S
FS
Balfour
H H
HH
Osterholm
M T
MT
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
D015483:HIV Antibodies