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Guidelines for appropriate evaluations of HIV testing technologies in Africa
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  • Description:
    Executive summary -- Background -- Serodiagnosis of HIV -- EIA -- Rapid/simple assays -- Importance of rapid/simple assays -- Synopsis of HIV testing strategies -- WHO/UNAIDS testing strategies -- Rational justifications for conducting test evaluations -- Evaluating HIV assays in Africa -- Justification for evaluating new HIV test kits -- Laboratory quality assurance (QA) and safety -- Importance of QA -- Quality control -- External quality assessment (EQA) -- Safety precautions -- Planning and evaluation -- Responsibilities of NRL -- Program coordination -- Funding considerations -- Test selection criteria for county-level evaluation -- Planning activities and timeline -- Technical training requirements -- Conducting the evaluation -- Overview of evaluation phases -- Objective of evaluation phases -- Evaluation scenarios advantages and disadvantages -- Phase I: laboratory evaluation -- Use of stored serum -- Sample population -- Phase II: field evaluation/pilot testing -- Number of sites -- Sample population -- Sample size -- Phase III: implementation and monitoring of test performance -- Training requirements -- EQA -- Onsite evaluation -- Proficiency testing -- Blinding rechecking -- Dried blood spots (DBS) -- Remediation/corrective measures -- Evaluation materials -- Types of evaluation materials -- Specimen collection and handling -- Specimen collection -- Plasma -- Serum -- While blood -- Transfer and storage of specimens -- Improving the quality of stored sera -- Serum library -- Characterization of evaluation panel -- Trouble-shooting of problematic samples -- Data analysis -- Data management -- Resolving discordants -- Sensitivity, specificity, PPV, NPV, CI, delta values, reproducibility, inter-reader variability of rapid tests -- Reporting results, conclusions, recommendations -- Developing an algorithm -- Reporting results -- Aggregation and dissemination of evaluation data -- Appendices.

    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.

  • 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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