Evaluation of testing algorithms following the use of combination HIV-1/HIV-2 EIA for screening purposes

AIDS Res Hum Retroviruses. 1993 Feb;9(2):147-51. doi: 10.1089/aid.1993.9.147.

Abstract

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.

Publication types

  • Comparative Study

MeSH terms

  • Algorithms
  • Evaluation Studies as Topic
  • HIV Antibodies / blood*
  • HIV Infections / diagnosis
  • HIV Infections / epidemiology
  • HIV Infections / immunology
  • HIV-1 / immunology*
  • HIV-2 / immunology*
  • Humans
  • Immunoenzyme Techniques / statistics & numerical data*
  • Licensure
  • Mass Screening
  • Risk Factors
  • Sensitivity and Specificity
  • United States / epidemiology
  • United States Food and Drug Administration

Substances

  • HIV Antibodies