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Consensus Meeting for Improving the Quality of
Laboratory Testing for HIV Surveillance
October 19-21
Hyatt Regency Atlanta
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Executive Summary Focusing on Recommendations
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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
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