Guidelines for Appropriate Evaluations of HIV Testing Technologies in Africa

This report is a guide for developing country-specific protocols for conducting evaluations of HIV enzyme immunoassay and rapid/simple test methods in Africa. It includes the background of each test, the importance of rapid/simple assays, the rationale and justification for evaluating new tests, the importance of quality assurance and safety, issues to be considered when planning an evaluation, projected time line for an evaluation, and technical training requirements. Detailed descriptions of phases of the evaluation quality assurance, evaluation materials, and laboratory safety precautions, data analysis, and reporting results are presented. The appendices include testing algorithms, a summary of the World Health Organization (WHO) Testing strategies, potential testing strategies, rapid test methodologies and degree of implementation, laboratory safety rules, sample evaluation expenditures, sample outline of an evaluation protocol, and confidence ranges.