Implementation of an interactive mobile application to pilot a rapid assay to detect HIV drug resistance mutations in Kenya.
Implementation of an interactive mobile application to pilot a rapid assay to detect HIV drug resistance mutations in Kenya.
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DOI：
10.1371/journal.pgph.0000185
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发表时间：
2022
期刊：
影响因子：
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通讯作者：
Beck, Ingrid A
中科院分区：
文献类型：
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作者：
Vrana, Justin D;Panpradist, Nuttada;Higa, Nikki;Ko, Daisy;Ruth, Parker;Kanthula, Ruth;Lai, James J;Yang, Yaoyu;Sakr, Samar R;Chohan, Bhavna;Chung, Michael H;Frenkel, Lisa M;Lutz, Barry R;Klavins, Eric;Beck, Ingrid A
可用性是实施基于实验室的测定的一个被忽视的方面，特别是在低资源环境中的新型测定。深奥的说明可能导致不可重现的测试结果和患者伤害。为了解决这些问题，我们开发了一个基于“水族馆”的软件应用程序，这是一个在平板电脑上运行的实验室操作系统，提供了一步一步的数字交互式指令，协议管理和样品跟踪。Aquarium与一种接近护理点的HIV耐药性测试“OLA-Simple”配对，该测试检测与病毒学失败相关的突变。在这项观察性研究中，我们评估了Aquarium在指导未经培训的用户通过多步实验室方案（几乎没有监督）方面的性能。为了评估Aquarium软件的培训，我们在肯尼亚内罗毕的科普特希望中心的实验室进行了可行性研究。12名不熟悉试剂盒的志愿者对盲态样本（2份血样; 5个密码子/样本）进行了检测。Aquarium指导的步骤包括：CD 4 + T细胞分离、PCR、连接、检测和检测结果解释。参与者填写了一份关于他们的人口统计数据和使用软件和工具包的经验的简短调查。所有实验室技术人员之前都没有进行CD 4+分离的经验，7/12没有进行实验室分子测定的经验。12/12例从全血中分离的CD 4 + T细胞的产率与经培训人员进行的分离相当。所有人都完成了OLA-Simple工作流程，其中108/120（90%）的基因分型结果通过裸眼正确解释，116/120（97%）的密码子通过软件正确解释。在调查中，参与者积极评价软件指导的使用。Aquarium数字化说明使肯尼亚的首次使用者能够以最少的培训完成OLA-simple套件工作流程。水族馆可以增加低资源环境中实验室检测的可及性，并可能使临床实验室检测的实施标准化。
Usability is an overlooked aspect of implementing lab-based assays, particularly novel assays in low-resource-settings. Esoteric instructions can lead to irreproducible test results and patient harm. To address these issues, we developed a software application based on “Aquarium”, a laboratory-operating system run on a computer tablet that provides step-by-step digital interactive instructions, protocol management, and sample tracking. Aquarium was paired with a near point-of-care HIV drug resistance test, “OLA-Simple”, that detects mutations associated with virologic failure. In this observational study we evaluated the performance of Aquarium in guiding untrained users through the multi-step laboratory protocol with little supervision. To evaluate the training by Aquarium software we conducted a feasibility study in a laboratory at Coptic Hope Center in Nairobi, Kenya. Twelve volunteers who were unfamiliar with the kit performed the test on blinded samples (2 blood specimens; 5 codons/sample). Steps guided by Aquarium included: CD4+ T-Cell separation, PCR, ligation, detection, and interpretation of test results. Participants filled out a short survey regarding their demographics and experience with the software and kit. None of the laboratory technicians had prior experience performing CD4+ separation and 7/12 had no experience performing laboratory-based molecular assays. 12/12 isolated CD4+ T cells from whole blood with yields comparable to isolations performed by trained personnel. The OLA-Simple workflow was completed by all, with genotyping results interpreted correctly by unaided-eye in 108/120 (90%) and by software in 116/120 (97%) of codons analyzed. In the surveys, participants favorably assessed the use of software guidance. The Aquarium digital instructions enabled first-time users in Kenya to complete the OLA-simple kit workflow with minimal training. Aquarium could increase the accessibility of laboratory assays in low-resource-settings and potentially standardize implementation of clinical laboratory tests.