Sensitivity and specificity of HIV rapid tests used for research and voluntary counselling and testing

East Afr Med J. 2008 Oct;85(10):500-4. doi: 10.4314/eamj.v85i10.9666.

Abstract

Background: HIV rapid tests (RT) are a quick and non-technically demanding means to perform HIV voluntary counselling and testing (VCT) but understanding their limitations is vital to delivering quality VCT.

Objective: To determine the sensitivity and specificity of HIV rapid tests used for research and voluntary counselling and testing at four sites in East Africa.

Design: Cross-sectional study.

Setting: Masaka District, Uganda; a sugar plantation in Kakira, Uganda; Coastal Villages in the Kilifi District of Kenya; and the Urban slum of Kangemi located West of Nairobi, Kenya.

Subjects: Six thousands two hundred and fifty five consenting volunteers were enrolled into the study, and 675 prevalent HIV infections were identified.

Results: The RT sensitivity tended to be high for all assays at all sites (97.63-100%) with the exception of the Uni-Gold assay (90.24% in Kangemi, 96.58% in Kilifi). Twenty four RT results were recorded as 'weak positives', 22 (92%) of which were negative by ELISA. There was a high rate of RT false positives in Uganda (positive predictive values ranging from 45.70% to 86.62%).

Conclusions: The sensitivity and specificity of the RT varied significantly across sites. The rate of RT misclassification in Uganda suggests that a multiple test algorithm may be preferable to a single test as screener for HIV VCT.

Publication types

  • Research Support, Non-U.S. Gov't
  • Validation Study

MeSH terms

  • AIDS Serodiagnosis / methods*
  • Adolescent
  • Adult
  • Algorithms
  • Cross-Sectional Studies
  • Directive Counseling / statistics & numerical data*
  • Enzyme-Linked Immunosorbent Assay
  • Feasibility Studies
  • Female
  • HIV Infections / diagnosis*
  • HIV Infections / epidemiology
  • HIV Infections / physiopathology
  • HIV-1 / isolation & purification*
  • Humans
  • Male
  • Middle Aged
  • Predictive Value of Tests
  • Reagent Kits, Diagnostic
  • Sensitivity and Specificity
  • Young Adult

Substances

  • Reagent Kits, Diagnostic