Field performance of a thin-layer chromatography assay for detection of nevirapine in umbilical cord blood

HIV Clin Trials. 2006 Sep-Oct;7(5):263-9. doi: 10.1310/hct0705-263.

Abstract

Purpose: Although cord blood surveillance can measure the effectiveness of nevirapine (NVP)-based programs for the prevention of mother-to-child HIV transmission (PMTCT), it requires the ability to detect nevirapine in plasma. At present, the only validated method is high-performance liquid chromatography (HPLC), a technique poorly suited for most resource-constrained settings.

Method: We evaluated the field performance for a simple and inexpensive thin-layer chromatography (TLC) assay for NVP detection. We developed a conditional probability model to compare 2 testing algorithms: HPLC alone, and TLC screening followed by HPLC confirmation of negative results.

Results: When compared to HPLC, sensitivity of TLC was 0.67 (95% confidence interval [CI] 0.49-0.84) and specificity was 0.84 (95% CI 0.69-0.95). In this sample - where overall NVP coverage was 49% - positive predictive value was 0.80 and negative predictive value was 0.72. At baseline with population NVP coverage of 33%, cost per specimen was lower in the TLC-HPLC testing algorithm (40 dollars vs. 50 dollars), and the proportion of false results was acceptable (11%). As population NVP coverage increased, cost-efficiency improved and error rate dropped substantially.

Conclusion: TLC is reasonably sensitive and specific for NVP detection. A 2-step testing algorithm incorporating TLC and HPLC provides cost-efficiency at little expense to test performance.

Publication types

  • Evaluation Study
  • Research Support, N.I.H., Extramural
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Algorithms
  • Anti-HIV Agents / pharmacokinetics*
  • Anti-HIV Agents / therapeutic use
  • Chromatography, High Pressure Liquid
  • Chromatography, Thin Layer* / economics
  • Cost-Benefit Analysis
  • Female
  • Fetal Blood / metabolism*
  • HIV Infections / metabolism*
  • HIV Infections / prevention & control
  • HIV Infections / transmission
  • HIV*
  • Humans
  • Infant, Newborn
  • Infectious Disease Transmission, Vertical / prevention & control
  • Nevirapine / pharmacokinetics*
  • Nevirapine / therapeutic use
  • Pregnancy
  • Pregnancy Complications, Infectious / metabolism*
  • Pregnancy Complications, Infectious / prevention & control
  • Prospective Studies
  • Sensitivity and Specificity
  • Treatment Outcome
  • Sambia

Substances

  • Anti-HIV Agents
  • Nevirapine