Evaluation and implementation of rapid HIV tests: the experience in 11 African countries.

Rapid HIV testing enables HIV prevention and care services to expand to settings with limited laboratory infrastructure. The World Health Organization recommends that prior to their implementation, rapid HIV tests first be evaluated at a reference laboratory and then at points-of-service, and that measures to ensure quality of testing be in place. We describe the experience of 11 African countries that implemented rapid HIV testing using this process. A questionnaire regarding rapid test evaluations and quality assurance measures was administered to personnel in ministries of health, reference laboratories, and Centers for Disease Control and Prevention programs in 11 African countries. In reference laboratory evaluations, median sensitivity was above 99% for 10 of 15 rapid tests and median specificity was above 99% for 13 of 15 rapid tests. Similar results were observed in evaluations at point-of-service sites. Rapid testing algorithms have been implemented in over 600 sites in nine of the countries. Concordance between point-of-service rapid testing and reference laboratory retesting of samples ranged from 95.7% to 99.5% (median: 98.7%). A systematic approach to the evaluation and implementation of rapid HIV tests was useful in ensuring accurate, decentralized testing even when conducted by persons with limited laboratory experience.