A train-and-assist device that upskills novices to strengthen the workforce and expand diagnostic access

Abstract Artificial intelligence and automation technologies are displacing millions of workers across industries in developed countries, while many developing nations continue to grapple with chronically high unemployment. Meanwhile, healthcare laboratories—particularly in resource-limited settings (including rural and community sites within high-income countries)—face acute shortages of trained staff and the high cost of molecular diagnostics. Here, we propose a “train-and-assist” class of devices that aims to both (i) upskill—rather than replace—workers and (ii) expand diagnostic capacity in a cost-effective way. We describe a device that trains and assists laboratory-inexperienced personnel to perform sample-pooling procedures, which enable high-performance molecular testing at lower costs and higher throughput. A 48-participant user study demonstrated that the device enabled both skill acquisition and high-accuracy pooling. A device-validation study using clinical stool specimens demonstrated that device-assisted pooling agreed 100% with individual assays for soil-transmitted helminths, which affect more than 1.5 billion people worldwide. Teaser We propose a new class of technologies that train and assist personnel to learn skills for complex laboratory tasks, with the goal of strengthening the diagnostics workforce and expanding healthcare access. Competing Interest Statement The authors have declared no competing interest. Funding Statement This work was funded in part by an Innovation Seed Grant from the Merkin Institute for Translational Research (Caltech) and the Jacobs Institute for Molecular Engineering for Medicine (Caltech). Author Declarations I confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained. Yes The details of the IRB/oversight body that provided approval or exemption for the research described are given below: This study included human participants research conducted in Pasadena, CA, United States of America. The research was reviewed by the California Institute of Technology Institutional Review Board (IRB) and determined meet the criteria for exemption pursuant to (45 C.F.R. 46.104(d)(2)(i),(ii)): Research that only includes interactions involving educational tests (e.g., cognitive, diagnostic, aptitude, achievement tests), survey procedures, interview procedures or observation of public behavior (IRB protocol #23-1366). In addition, this study utilized archived clinical samples collected in Bangladesh (study sites: Gazipur, Kishoreganj, Mymensingh, and Tangail districts) during 2015-2016 from research conducted at icddr,b. The sample collection was approved by the Ethical Review Committee at icddr,b (PR-11063), the Committee for the Protection of Human Subjects at the University of California, Berkeley (2011-09-3652), and the institutional review board at Stanford University (25863). The local researchers identified eligible communities through area surveys, traveled to the eligible communities, asked community leaders for permission to conduct research within their community, and recruited participants with formal informed consent for the study in the communities under the permission from the leaders. I confirm that all necessary patient/participant consent has been obtained and the appropriate institutional forms have been archived, and that any patient/participant/sample identifiers included were not known to anyone (e.g., hospital staff, patients or participants themselves) outside the research group so cannot be used to identify individuals. Yes I understand that all clinical trials and any other prospective interventional studies must be registered with an ICMJE-approved registry, such as ClinicalTrials.gov. I confirm that any such study reported in the manuscript has been registered and the trial registration ID is provided (note: if posting a prospective study registered retrospectively, please provide a statement in the trial ID field explaining why the study was not registered in advance). Yes I have followed all appropriate research reporting guidelines, such as any relevant EQUATOR Network research reporting checklist(s) and other pertinent material, if applicable. Yes Data, Materials, and Software Availability The datasets generated and analyzed during the current study, including all device designs and related codes, are available at CaltechDATA: https://doi.org/10.22002/wnh8n-mh110. Four videos are available at the link. All statistical analysis results are available in the Supporting Information Tables.