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Guidelines for assuring the accuracy and reliability of HIV rapid testing : applying a quality system approach
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c2005
[PDF-1.09 MB]
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Description:NPIN 33841: "This monograph provides guidelines for applying a quality system approach to HIV rapid testing. The quality system is divided into twelve essential elements: Organization and Management, Personnel, Equipment, Purchasing and Inventory, Process Control, Documents and Records, Information Management, Occurrence Management, Assessment, Process Improvement, Service and Satisfaction, Facilities and Safety. The monograph outlines the responsibilities at the national level for establishing a laboratory quality system, the planning that is required, and the responsibilities at the laboratory or facility level. It discusses the importance of the initial and ongoing training and evaluation of personnel; evaluation methods; standard operating procedure; and quality control procedures. The appendices present a CDC/WHO training program for rapid testing, examples of a stock card and stock book to use for inventory control, an example of a standard operating procedure, a quality control form, a protocol for preparing HIV-positive quality control materials, external quality assessment of HIV rapid tests and on-site monitoring including an onsite monitoring checklist, and examples of documents and records useful in a rapid testing site."
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Content Notes:Jointly published by the World Health Organization, Centers for Disease Control and Prevention (U. S.), Office of the United States Global AIDS Coordinator, and the U. S. Dept. of Health and Human Services.
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