Home I. Executive Summary II. Background III. Goals of the Meeting IV. Venue and Invited Participants V. Surveillance Overview VI. Testing Algorithms VII. Quality Systems VIII. ARV Resistance Testing for Surveillance IX. Surveillance of Recent HIV Infections

Consensus Meeting for Improving the Quality of Laboratory Testing for HIV Surveillance October 19-21 Hyatt Regency Atlanta Executive Summary Focusing on Recommendations        The critical objectives of this meeting were to review current approaches in laboratory support for HIV surveillance, identify potential sources of laboratory-based errors, and propose approaches and recommendations for the improvement of the quality of laboratory test results. Currently, the WHO/UNAIDS/CDC/USAID booklet "Using HIV Testing Technologies in Surveillance" (WHO/CDS/CSR/EDC/2001.16, UNAIDS/01.22E) has served as the most important guideline for HIV surveillance activities. While this document remains relevant for general recommendations, activities in HIV high-burden countries have highlighted the need for providing additional information in an updated guideline. Discussions at this meeting resulted in recommendations that will be used to begin this process. Recommendations from the meeting include: Testing algorithm A two test strategy (Strategy II) is recommended irrespective of HIV prevalence Testing in-country is best performed decentralized to allow for capacity building in regional or zonal laboratories Rapid tests, automated EIA and combinations are appropriate for the two test strategy The Western blot assay is not recommended for surveillance testing An acceptable level of discordance during serial testing should be calculated based on HIV prevalence and particular test algorithm in use (Spread sheet developed by Dr. Mark Shields)   Quality systems Expanded descriptions of the twelve elements of a quality system (Organization, Personnel, Documents and Records, Procurement and Inventory Management, Information Management, Process Control, Equipment, Process Improvement, Assessment, Facilities and Safety, Occurrence Management, and Customer Satisfaction) Detailed descriptions of the factors and activities that must be addressed to ensure adherence to a quality system resulting in dependable and reliable surveillance data   ARV resistance testing for surveillance Threshold surveys for HIV drug resistance (HIV-DR) among HIV-infected, untreated persons should be a priority in high-burden countries WHO and CDC communication and cooperative efforts for HIV-DR testing should be strengthened Serum specimens must be handled appropriately for quality results Laboratories performing HIV-DR assay must have previous experience with this assay Development of software for a standardized HIV-DR database should be a priority   Surveillance of recent HIV infections BED Capture EIA recommended for incidence testing Capable of detecting HIV-antibodies to various subtypes Standardized protocol using commercially available kit Centralized testing is recommended In order to ensure appropriate use of the assay and interpretation of the data, training and technical assistance will be needed for laboratory and surveillance activities Testing should be implemented on sero-positive specimens in countries already performing quality HIV antibody testing Ideally, several rounds of testing should be performed in the same laboratory to establish proficiency and demonstrate trends