Division of Infectious Diseases, Department of Pediatrics, University of Washington.
Seattle Children's Research Institute, Seattle, Washington, USA.
AIDS. 2018 Oct 23;32(16):2301-2308. doi: 10.1097/QAD.0000000000001934.
An increasing prevalence of HIV pretreatment drug resistance (PDR) has been observed in Africa, which could decrease the effectiveness of antiretroviral therapy (ART) programs. We describe our experiences, the costs and challenges of implementing an oligonucleotide ligation assay (OLA) for management of PDR in Nairobi, Kenya.
An observational report of the implementation of OLA in a Kenyan laboratory for a randomized clinical trial evaluating whether onsite use of OLA in individuals initiating ART would decrease rates of virologic failure.
Compared detection of mutations and proportion of mutants in participants' viral quasispecies by OLA in Kenya vs. Seattle. Reviewed records of laboratory workflow and performance of OLA. Calculated the costs of laboratory set-up and of performing the OLA based on equipment purchase receipts and supplies and labor utilization, respectively.
OLA was performed on 492 trial participants. Weekly batch-testing of median of seven (range: 2-13) specimens provided test results to Kenyan clinicians within 10-14 days of sample collection at a cost of US$ 42 per person tested. Cost of laboratory setup was US$ 32 594. Challenges included an unreliable local supply chain for reagents and the need for an experienced molecular biologist to supervise OLA performance.
OLA was successfully implemented in a Kenyan research laboratory. Cost was twice that projected because of fewer than predicted specimens per batch because of slow enrollment. OLA is a potential simple, low-cost method for PDR testing in resource-limited settings (RLS). Ongoing work to develop a simplified kit could improve future implementation of OLA in RLS.
在非洲，HIV 预处理耐药性（PDR）的流行率不断上升，这可能会降低抗逆转录病毒疗法（ART）项目的效果。我们描述了在肯尼亚内罗毕实施寡核苷酸连接检测（OLA）来管理 PDR 的经验、成本和挑战。
这是一项关于在肯尼亚实验室实施 OLA 的观察性报告，用于评估在开始接受 ART 的个体中现场使用 OLA 是否会降低病毒学失败率的随机临床试验。
比较肯尼亚和西雅图的 OLA 检测参与者病毒准种中的突变和突变体比例。审查实验室工作流程和 OLA 性能的记录。根据设备购买收据和供应品以及劳动力利用情况，分别计算实验室设置和执行 OLA 的成本。
OLA 共用于 492 名试验参与者。每周对 7 份（范围：2-13）标本进行批量测试，在肯尼亚临床医生收到标本采集后 10-14 天内提供了测试结果，每人测试的费用为 42 美元。实验室设置成本为 32594 美元。面临的挑战包括试剂的当地供应链不可靠以及需要有经验的分子生物学家来监督 OLA 的性能。
OLA 在肯尼亚研究实验室中成功实施。由于每批标本少于预期，因为招募速度较慢，成本比预计的高出两倍。OLA 是资源有限环境中 PDR 检测的一种有潜力的简单、低成本方法。正在进行简化试剂盒的开发工作，这可能会改善未来在资源有限环境中实施 OLA。
