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Guidelines for appropriate evaluations of HIV testing technologies in Africa
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Description:Ensuring the quality of HIV testing in support of prevention and care efforts has been identified as a priority by the U.S. Centers for Disease Control and Prevention (CDC) and the World Health Organization/African Regional Office (WHO/AFRO). Rapid/simple HIV tests are marketed widely, and promoted for use by a variety of HIV/AIDS prevention strategies such as voluntary counseling and testing (VCT) and prevention of mother to child transmission (MTCT). It is vitally important that before these and other HIV assays are utilized, countries evaluate the performance of each assay to determine its performance characteristics and suitability for use within a given country setting. This evaluation is considered a critical aspect of assuring the quality of test results, and all countries must make this a priority. This document is intended to provide those involved with planning or conducting any aspect of test evaluations practical guidance for developing country-specific protocols for conducting evaluations of HIV EIA and rapid/simple test methods. As test evaluations require both time and resources, specific guidance is given on the rationale and justification for evaluating new tests, issues to consider when planning an evaluation, and projected timeline for an evaluation. Detailed descriptions of phases of the evaluation quality assurance, evaluation materials, e.g., specimens, and laboratory safety precautions are also presented in this document.
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Content Notes:The Centers for Disease Control and Prevention (CDC) and the African Regional Office of the World Health Organization (WHO/AFRO) wishes to express their gratitude to individuals who contributed their time and expertise by participating in a workgroup meeting November 28- December 1, 2001 in Harare, Zimbabwe, to develop these guidelines.
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