Poor sensitivity of field rapid HIV testing: implications for mother-to-child transmission programme

BJOG. 2009 Dec;116(13):1805-8. doi: 10.1111/j.1471-0528.2009.02357.x. Epub 2009 Sep 9.

Abstract

We validated rapid HIV tests among pregnant women in a clinical setting. Field testing was performed using First Response 1,2,3 or Standard Diagnostic and Pareekshak tests. Results were confirmed by third generation HIV ELISA. Discordant or negative, specimens were confirmed by RNA PCR and a fourth generation ELISA test. Sensitivity and specificity were 94.5% (CI: 85.8-98.2) and 100% for First Response; 87.5% (CI: 46.7-99.3) and 100% (CI: 87.7-100%) for Standard Diagnostic and 90.2% (CI: 81.2-95.4) and 100% (CI: 98-100%) for Pareekshak. These sensitivities were lower than laboratory validation which approached 100%. The low-field sensitivity results have implications for Prevention of Mother-to-Child Transmission services.

Publication types

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

MeSH terms

  • AIDS Serodiagnosis
  • Adult
  • Female
  • HIV Infections / diagnosis*
  • HIV Infections / prevention & control
  • HIV Infections / transmission
  • HIV-1*
  • Humans
  • Infectious Disease Transmission, Vertical / prevention & control*
  • Point-of-Care Systems
  • Pregnancy
  • Pregnancy Complications, Infectious / diagnosis*
  • Prenatal Diagnosis / methods
  • Reagent Kits, Diagnostic
  • Reproducibility of Results
  • Sensitivity and Specificity

Substances

  • Reagent Kits, Diagnostic