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IntroductionThe ongoing SARS-CoV-2 pandemic has spurred the development of numerous point of care (PoC) immunoassays. Assessments of performance of available kits are necessary to determine their clinical utility. Previous studies have mostly performed these assessments in a laboratory setting, which raises concerns of translating findings for PoC use. The aim of this study was to assess the performance of a lateral flow immunoassay for the detection of SARS-CoV-2 antibodies using samples collected at PoC.MethodOne lateral flow immunoassay (Humasis® COVID-19 IgG/IgM) was tested. In total, 50 PCR RT-PCR positive and 52 RT-PCR negative samples were collected at PoC. Fifty serum specimens from Dec 2018 to Feb 2019 were used as controls for specificity. Serum samples collected between Dec 2019 to Feb 2020 were used as additional comparators. Clinical data including symptom onset date was collected from patient history and the medical record.ResultsThe overall sensitivity for the kit was 74% (95% CI: 59.7% -85.4%). The sensitivity for IgM and IgG detection >14 days after date of onset was 88% (95% CI: 68.8% -97.5%) and 84% (95% CI: 63.9% – 95.5%), with a negative predictive value (NPV) of 94% for IgM (95% CI: 83.5% - 98.8%) and 93% for IgG (95% CI: 81.8% - 97.9%). The overall specificity was 94% (95% CI: 83.5% - 98.8%). The Immunoglobulin specific specificity was 94% for IgM (95% CI: 83.5% - 98.8%) and 98% for IgG (95% CI: 89.4% - 100.0%), with a positive predictive value (PPV) of 88% for IgM (95% CI: 68.8% - 97.5%) and 95% for IgG (95% CI: 77.2% - 99.9%) respectively for samples collected from patients >14 days after date of onset. Specimen collected during early phase of COVID-19 pandemic (Dec 2019 to Feb 2020) showed 11.8% antibody positivity, and 11.3% of PCR-negative patients demonstrated antibody positivity.DiscussionHumasis® COVID-19 IgG/IgM LFA demonstrates greater than 90% PPV and NPV for samples collected 14 days after the onset of symptoms using samples collected at PoC. While not practical for the diagnosis of acute infection, the use of the lateral flow assays with high specificity may have utility for determining seroprevalence or seroconversion in longitudinal studies.

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Background Health systems in low- and middle-income countries face considerable challenges in providing high-quality accessible care. eHealth has had mounting interest as a possible solution given the unprecedented growth in mobile phone and internet technologies in these locations; however, few apps or software programs have, as of yet, gone beyond the testing phase, most downloads are never opened, and consistent use is extremely rare. This is believed to be due to a failure to engage and meet local stakeholder needs and the high costs of software development. Objective World Health Organization Basic Emergency Care course participants requested a mobile point-of-care adjunct to the primary course material. Our team undertook the task of developing this solution through a community-based participatory model in an effort to meet trainees’ reported needs and avoid some of the abovementioned failings. We aimed to use the well-described Lean software development strategy—given our familiarity with its elements and its ubiquitous use in medicine, global health, and software development—to complete this task efficiently and with maximal stakeholder involvement. Methods From September 2016 through January 2017, the Basic Emergency Care app was designed and developed at the University of California San Francisco. When a prototype was complete, it was piloted in Cape Town, South Africa and Dar es Salaam, Tanzania—World Health Organization Basic Emergency Care partner sites. Feedback from this pilot shaped continuous amendments to the app before subsequent user testing and study of the effect of use of the app on trainee retention of Basic Emergency Care course material. Results Our user-centered mobile app was developed with an iterative participatory approach with its first version available within 6 months and with high acceptance—95% of Basic Emergency Care Course participants felt that it was useful. Our solution had minimal direct costs and resulted in a robust infrastructure for subsequent assessment and maintenance and allows for efficient feedback and expansion. Conclusions We believe that utilizing Lean software development strategies may help global health advocates and researchers build eHealth solutions with a process that is familiar and with buy-in across stakeholders that is responsive, rapid to deploy, and sustainable.

The Institutional Review Boards of the University of California at San Francisco and Muhimbili National Hospital reviewed and approved the study and its methods.A mixed methods needs assessment of pediatric emergency and critical care in Tanzanian providers: a model for curriculum...

BACKGROUND Health systems in low- and middle-income countries face considerable challenges in providing high-quality accessible care. eHealth has had mounting interest as a possible solution given the unprecedented growth in mobile phone and internet technologies in these locations; however, few apps or software programs have, as of yet, gone beyond the testing phase, most downloads are never opened, and consistent use is extremely rare. This is believed to be due to a failure to engage and meet local stakeholder needs and the high costs of software development. OBJECTIVE World Health Organization Basic Emergency Care course participants requested a mobile point-of-care adjunct to the primary course material. Our team undertook the task of developing this solution through a community-based participatory model in an effort to meet trainees’ reported needs and avoid some of the abovementioned failings. We aimed to use the well-described Lean software development strategy—given our familiarity with its elements and its ubiquitous use in medicine, global health, and software development—to complete this task efficiently and with maximal stakeholder involvement. METHODS From September 2016 through January 2017, the Basic Emergency Care app was designed and developed at the University of California San Francisco. When a prototype was complete, it was piloted in Cape Town, South Africa and Dar es Salaam, Tanzania—World Health Organization Basic Emergency Care partner sites. Feedback from this pilot shaped continuous amendments to the app before subsequent user testing and study of the effect of use of the app on trainee retention of Basic Emergency Care course material. RESULTS Our user-centered mobile app was developed with an iterative participatory approach with its first version available within 6 months and with high acceptance—95% of Basic Emergency Care Course participants felt that it was useful. Our solution had minimal direct costs and resulted in a robust infrastructure for subsequent assessment and maintenance and allows for efficient feedback and expansion. CONCLUSIONS We believe that utilizing Lean software development strategies may help global health advocates and researchers build eHealth solutions with a process that is familiar and with buy-in across stakeholders that is responsive, rapid to deploy, and sustainable.

Disparities in diagnosis, treatment, and health outcomes of racial minorities are well documented in the emergency department (ED). Although EDs may provide broad departmental feedback on clinical metrics, lack of up‐to‐date monitoring and data availability present significant challenges to identifying and addressing patterns of inequitable care. To address this issue, we developed an online “Equity Dashboard,” incorporating data that is updated daily from our electronic medical record to highlight demographic, clinical, and operational variables, stratified by age, race, ethnicity, and language, and sexual orientation, gender identity. Through an iterative design thinking process, we created data visualizations for an interactive interface that tells a story about the ED patient's experience and enables any staff to explore up‐to‐date trends in patient care. To assess and improve usability of the dashboard, we conducted a survey of end‐users using custom questions, as well as the System Usability Scale and Net Promoter Score, both of which are validated health technology use instruments. The Equity Dashboard is of particular use for quality improvement initiatives, as it reflects common departmental challenges including delays in clinician events, inpatient boarding, and throughput metrics. This digital tool further helps demonstrate how these operational factors differentially affect our diverse patient population. The dashboard ultimately enables the ED team to measure current performance, to identify our vulnerabilities, and to design targeted interventions to address disparities in clinical care.