Usability and performance of the MicroGEM Sal6830™, an RT-PCR saliva-based point-of-care platform to detect SARS-CoV-2 in primary healthcare settings with non-laboratory trained operators

Abstract

The beginning of the COVID-19 pandemic demonstrated how few point-of-care diagnostic tools were available that could be safely and easily operated by healthcare workers with no laboratory training. The gold-standard test, and initially the only test, used RT-PCR with nasal pharyngeal swabs (NPS). Two issues quickly emerged: 1) RT-PCR required central laboratory processing leading to significant time delays and 2) NPS collection causes discomfort, is inappropriate for ongoing repeat sampling of individuals (e.g., frontline healthcare workers) and poses difficulty when obtaining samples from some sections of the population (e.g. some elderly and young children). The Sal6830 platform is a fully self-contained, RT-PCR point-of-care device for detecting SARS-CoV-2 from saliva that takes less than thirty minutes to complete. In this study we tested the usability of the Sal6830 platform by healthcare workers unfamiliar with the instrument at two community clinics: Care 4 U Community Health Center (Miami, Florida, USA) and St. Marys Health Wagon (Wise, Virginia, USA). Staff participated in three tests: 1) determining SARS-CoV-2 status from blinded positive and negative saliva samples, 2) a clinical study comparing SARS-CoV-2 detection with a comparator point-of-care technology from the same patient and 3) completing a survey designed to measure comfort and confidence using the Sal6830 point-of-care device having received no training. Participants overwhelming found the Sal6830 platform easy and intuitive to use, successfully called SARS-CoV-2 status of contrived, blinded samples and measured a 93.3% overall percent agreement when comparing patient samples across two point-of-care technologies.