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5th International AIDS Society Conference on HIV Pathogenesis and TreatmentCape Town - July 19 - 22, 2009 |
AIDS CLINICAL TRIALS GROUP (ACTG) NETWORK LABORATORY QUALITY ASSURANCE (QA) MONITORING: A TOOL TO IMPROVE THE QUALITY OF HIV/AIDS CLINICAL RESEARCH LABORATORIES IN RESOURCE LIMITED SETTINGS
IAS Conf HIV Pathog Treat 2009 Jul 19-22;5th: Abstract No. MOPDD104
A.M. Shahkolahi
1, K. Kaiss1, E. Meeks1, R. Coombs2
1Social & Scientific Systems, Inc., Silver Spring, United States, 2University of Washington Seattle, Washington, United States
BACKGROUND: Participation in External Quality Assessment (EQA) is a key element for the evaluation and improvement of testing procedures. We report on the results of the ACTG international laboratory EQA monitoring program.
METHODS: ACTG International Laboratories (AILs) are required to participate in the College of American Pathologist (CAP) proficiency program for general safety testing; Virology Quality Assurance Program (VQAP) for HIV RNA, DNA and genotyping analysis; and UKNEQAS for CD4 testing. Completion of training programs in electronic laboratory data management, international shipping of specimens, a pharmacology specimen collection tutorial and certification in good clinical laboratory practices are required. The laboratories must pass two consecutive EQA proficiency-testing rounds for all protocol-specified analytes. Laboratory performance is assessed annually via a scheduled independent audit. Monitoring of the EQA performance is coordinated with the sponsor (National Institutes of Health, Division of AIDS).
RESULTS: From 2002 to 2008, a total of twenty-five AILs have participated in 11 protocols with laboratory components that have enrolled 3248 subjects. The median (inter-quartile range) time taken for the laboratories to reach protocol certification status was 21 months (9-33). For 2008, there were 87 investigational reports for safety testing submitted by the laboratories. The average laboratory performance for safety testing (chemistry, serology and urine analysis) was 98%. The VQAP performance status was 90% “Approved” and 10% “Provisionally Approved” for HIV RNA-PCR viral load testing; 91% “Approved” and 9% “Provisionally Approved” for HIV DNA detection; and four (100%) laboratories were approved for HIV genotyping. UKNEQAS reported that 81% of the 25 participating laboratories received “Satisfactory” and 19% received “Provisionally Satisfactory” scores for CD4 testing.
CONCLUSIONS: An integrated EQA laboratory program has been established successfully at 25 international ACTG laboratory sites. This EQA program is essential for evaluating laboratory performance and improving the quality of laboratory data for ACTG clinical trials.
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2009-07-22
MOPDD104
Operations Research to Improve Laboratory Diagnosis and Monitoring
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