Scaling Up HIV Rapid Testing in Developing Countries Comprehensive Approach for Implementing Quality Assurance
Scaling Up HIV Rapid Testing in Developing Countries Comprehensive Approach for Implementing Quality Assurance
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DOI：
10.1309/ajcptdimfr00ikyx
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发表时间：
2010-10-01
影响因子：
3.5
通讯作者：
Nkengasong, John N.
中科院分区：
文献类型：
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作者：
Parekh, Bharat S.;Kalou, Mireille B.;Nkengasong, John N.
在过去几年中，为了响应联合国艾滋病规划署和世界卫生组织关于普遍获得预防、护理和治疗的呼吁，在世界范围内扩大了艾滋病毒快速检测的使用。艾滋病毒快速检测由具有不同技能的人员在实验室和非实验室环境中进行。准确的艾滋病毒诊断检测是确定感染者以便进行后续转诊和护理的第一步。然而，在测试试剂盒质量、测试选择、测试算法、培训、质量保证（QA）、新批次质量和上市后性能方面存在一些挑战。我们强调了影响艾滋病毒快速检测质量的各种问题，并提供了监测和提高检测准确性的解决方案，特别是在资源有限的情况下。这些措施包括使用经过验证的试剂盒、重点放在QA上的培训、使用标准化日志簿、基于干管标本的能力测试、新试剂盒批次验证和上市后监督。系统地实施这些工具将大大提高艾滋病毒快速检测的质量。
In the last few years, the use of HI V rapid testing has expanded worldwide in response to the call for universal access to prevention, care, and treatment by UNAIDS and the World Health Organization. HIV rapid testing is performed by people with varied skills in laboratory and nonlaboratory settings. Accurate HIV diagnostic testing is the first step to identifying infected persons for follow-up referral and care. However, there are several challenges related to test kit quality, test selection, testing algorithms, training, quality assurance (QA), quality of new lots, and postmarket performance. We highlight various issues that impact the quality of HIV rapid testing and provide solutions to monitor and improve test accuracy, especially in resource-limited settings. These include the use of validated kits, training with emphasis on QA, use of a standardized log book, dried-tube specimen based proficiency testing, new kit lot verification, and postmarket surveillance. Systematic implementation of these tools should greatly enhance the quality of HIV rapid testing.