Structural Challenges in Deployment of an Open-Source Diagnostic by Independent Researchers During a Public Health Emergency

Open-source diagnostic products have the potential to address some of the major challenges of diagnostic access revealed during the COVID-19 pandemic. However, as it stands, the current approval model in the US is poorly suited for such tests. In March 2020, early in the COVID-19 pandemic, a small group of independent scientists with members located in Illinois, New York, and Georgia collaborated on developing an open-source, patent-free COVID-19 diagnostic test. Within a few short months, we had developed a reliable test and published the protocol online with the hope that this simple, yet sensitive test would be adopted for widespread testing in laboratories, schools, and workplaces. However, we encountered several unexpected barriers to deployment of the test. This essay describes our experience and proposes a novel solution to reduce the barriers that limit meaningful contributions by independent researchers to addressing healthcare challenges in the United States. © 2022 Ubiquity Press. All rights reserved.

Screening of GDM during covid epidemia. Comparison between IADPSG and WHO '99 criteria

INTRODUCTION At the beginning of COVID epidemia, Italian Diabetes Societies advised pregnant women to not perform GDM screening with an Oral Glucose Tolerance Test (OGTT), but with a single fast glycemia value (≥92 mg/dl) at 24-28 weeks gestation. METHODS All pregnant women who performed an OGTT following IADPSG criteria and then delivered at our University Hospital from march 2020 to march 2021 were prospectively enrolled in this study. Primary outcome of the study was the number of women to whom was diagnosed GDM with only the fasting glucose value, following Italian Diabetes Society recommendations for COVID period. In the same time, we collected the data of women who became diabetic following the criteria of WHO 1999 (fast glucose value ≥120mg/dl, 2 h later ≥140mg/dl) still in use in some large countries like India. These women, who didn't meet IADPSG criteria had no treatment or glycemia monitoring. Clinical outcomes such as hypertensive disorders, preterm birth, macrosomia, intrauterine growth restriction and Caesarean section in emergency were compared between the 2 groups. RESULTS The number of women with a diagnosis of GDM in the 12-month period considered was 118. Only 77 (65%) had a fast glucose value ≥92 mg/dl thus if we had followed the Italian Diabetes Association, we lost 1/3 of GDM diagnosis. In the same period, pregnant women with a diagnosis of GDM following WHO '99 recommendations were 44. This group experienced the lowest rate of all clinical outcomes considered;furthermore, it was not monitored and not treated. CONCLUSIONS Although with limited numbers, our experience demonstrated that performing GDM diagnosis with a single value of fasting glycemia might fail for one-third of cases. The other result of the study is that is very hard to compare western studies performed with IADPGS criteria with those in which WHO '99 criteria are used, probably for the deep metabolic differences between populations considered.