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
Department of Bioengineering, University of Washington, Seattle, Washington, United States of America.
Global Health of Women, Adolescents, and Children (Global WACh), School of Public Health, University of Washington, Seattle, Washington, United States of America.
PLOS Glob Public Health. 2022 Feb 16;2(2):e0000185. doi: 10.1371/journal.pgph.0000185. eCollection 2022.
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.
可用性是实施基于实验室的检测方法时被忽视的一个方面，在资源匮乏地区实施新型检测方法时尤其如此。晦涩难懂的说明可能导致检测结果无法重复，并对患者造成伤害。为了解决这些问题，我们基于“Aquarium”开发了一款软件应用程序，“Aquarium”是一种运行在平板电脑上的实验室操作系统，可提供逐步的数字交互式说明、方案管理和样本跟踪。Aquarium与一种接近即时检验的HIV耐药性检测方法“OLA-Simple”配套使用，该方法可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在几乎无需监督的情况下指导未经培训的用户完成多步骤实验室方案的性能。为了评估Aquarium软件的培训效果，我们在肯尼亚内罗毕科普特希望中心的一个实验室进行了一项可行性研究。12名不熟悉该试剂盒的志愿者对盲样（2份血液标本；每份标本检测5个密码子）进行了检测。Aquarium指导的步骤包括：CD4+T细胞分离、聚合酶链反应（PCR）、连接、检测以及检测结果的解读。参与者填写了一份关于他们的人口统计学信息以及使用该软件和试剂盒的经验的简短调查问卷。没有一名实验室技术人员此前有过进行CD4+分离的经验，12人中有7人没有进行基于实验室的分子检测的经验。12名参与者均成功从全血中分离出了CD4+T细胞，其产量与经过培训的人员进行分离的产量相当。所有人都完成了OLA-Simple的工作流程，在分析的120个密码子中，有108个（90%）通过肉眼正确解读了基因分型结果，有116个（97%）通过软件正确解读。在调查中，参与者对软件指导的使用给予了积极评价。Aquarium数字说明使肯尼亚的首次使用者能够在极少培训的情况下完成OLA-Simple试剂盒的工作流程。Aquarium可以提高资源匮乏地区实验室检测方法的可及性，并有可能使临床实验室检测的实施标准化。
