一种全面的方法来确保 HIV 监测中实验室检测的质量：从基于人群的 HIV 影响评估项目中吸取的经验教训。
A Comprehensive Approach to Assuring Quality of Laboratory Testing in HIV Surveys: Lessons Learned From the Population-Based HIV Impact Assessment Project.
机构信息
Division of Global HIV/TB, Centers for Disease Control and Prevention, Atlanta, GA; and.
ICAP at Columbia University, New York, NY.
出版信息
J Acquir Immune Defic Syndr. 2021 Aug 1;87(Suppl 1):S17-S27. doi: 10.1097/QAI.0000000000002702.
BACKGROUND
Conducting HIV surveys in resource-limited settings is challenging because of logistics, limited availability of trained personnel, and complexity of testing. We described the procedures and systems deemed critical to ensure high-quality laboratory data in the population-based HIV impact assessments and large-scale household surveys.
METHODS
Laboratory professionals were engaged in every stage of the surveys, including protocol development, site assessments, procurement, training, quality assurance, monitoring, analysis, and reporting writing. A tiered network of household, satellite laboratories, and central laboratories, accompanied with trainings, optimized process for blood specimen collection, storage, transport, and real-time monitoring of specimen quality, and test results at each level proved critical in maintaining specimen integrity and high-quality testing. A plausibility review of aggregate merged data was conducted to confirm associations between key variables as a final quality check for quality of laboratory results.
RESULTS
Overall, we conducted a hands-on training for 3355 survey staff across 13 surveys, with 160-387 personnel trained per survey on biomarker processes. Extensive training and monitoring demonstrated that overall, 99% of specimens had adequate volume and 99.8% had no hemolysis, indicating high quality. We implemented quality control and proficiency testing for testing, resolved discrepancies, verified >300 Pima CD4 instruments, and monitored user errors. Aggregate data review for plausibility further confirmed the high quality of testing.
CONCLUSIONS
Ongoing engagement of laboratory personnel to oversee processes at all levels of the surveys is critical for successful national surveys. High-quality population-based HIV impact assessments laboratory data ensured reliable results and demonstrated the impact of HIV programs in 13 countries.
背景
在资源有限的环境中开展 HIV 调查具有挑战性，这是因为后勤工作、训练有素的人员有限，以及检测的复杂性。我们描述了确保基于人群的 HIV 影响评估和大规模家庭调查中获得高质量实验室数据的关键程序和系统。
方法
实验室专业人员参与了调查的各个阶段，包括方案制定、现场评估、采购、培训、质量保证、监测、分析和报告撰写。家庭、卫星实验室和中央实验室的分层网络，以及配套的培训，优化了血液样本采集、储存、运输和实时监测样本质量和各级检测结果的流程，对于保持样本完整性和高质量检测至关重要。对汇总合并数据进行似真性审查，以确认关键变量之间的关联，作为实验室结果质量的最终质量检查。
结果
总的来说，我们在 13 项调查中对 3355 名调查人员进行了实地培训，每轮调查培训生物标志物流程的人员为 160-387 人。广泛的培训和监测表明，总体而言，99%的样本体积充足，99.8%无溶血，表明质量很高。我们对检测实施了质量控制和能力验证，解决了差异，验证了>300 台 Pima CD4 仪器，并监测了用户错误。对汇总数据进行似真性审查，进一步证实了检测的高质量。
结论
实验室人员持续参与监督调查各个层面的流程，对于成功开展国家调查至关重要。高质量的基于人群的 HIV 影响评估实验室数据确保了可靠的结果，并展示了 13 个国家的 HIV 规划的影响。
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