Evaluation of testing algorithms following the use of combination HIV-1/HIV-2 EIA for screening purposes.
The licensure of combination human immunodeficiency virus type 1 and type 2 (HIV-1/HIV-2) enzyme immunoassays (EIAs) by the Food and Drug Administration has been accompanied by a recommendation that U.S. blood banks begin testing the nation's blood supply for HIV-2 by June 1, 1992. The performance of a recently licensed combination HIV-1/HIV-2 EIA (Genetic Systems) was evaluated using 3100 sera collected in the United States. A total of 2,049 sera were obtained from populations with low risk for HIV infections, and 1,051 sera from populations with high-risk behaviors. The combination EIA, in comparison with monospecific EIA, was found to be 100% sensitive for HIV-1 for both populations. The high-risk population had an HIV-1 seroprevalence rate of 17.4%, with a positive predictive value (PPV) of 97.3%. The low-risk population had an HIV-1 seroprevalence of 0.05% with a PPV of 8%. The incorporation of the combination EIA in various testing algorithms was also evaluated, and recommendations are given with consideration for the type of screening and populations involved.
Holloman
D L
DL
Division of HIV/AIDS, Centers for Disease Control, Atlanta, GA 30333.
Pau
C P
CP
Parekh
B
B
Schable
C
C
Onorato
I
I
Schochetman
G
G
George
J R
JR
D000465:Algorithms; D005069:Evaluation Studies as Topic; D015483:HIV Antibodies / Q000097:blood*; D015658:HIV Infections / Q000175:diagnosis / Q000453:epidemiology / Q000276:immunology; D015497:HIV-1 / Q000276:immunology*; D015498:HIV-2 / Q000276:immunology*; D006801:Humans; D007124:Immunoenzyme Techniques / Q000706:statistics & numerical data*; D008004:Licensure; D008403:Mass Screening; D012307:Risk Factors; D012680:Sensitivity and Specificity; D014481:United States / Q000453:epidemiology; D014486:United States Food and Drug Administration
D015483:HIV Antibodies