Rapid Manufacturing Scale-up for Compact Point-of-Care EUA SARS-CoV-2 RT-PCR Test

Background: The purpose of this study was to evaluate the performance of a sample-to-answer nucleic acid PCR amplification platform for point-of-care (POC) detection of SARS-CoV-2, with the goal of expanding its Emergency Use Authorization (EUA) from use with symptomatic, healthcare provider-collected specimens to include asymptomatic individuals and self-collected mid-turbinate samples.

Materials/Methods: This was a prospective clinical study comparing the POC PCR device to the Roche 6800 Cobas PCR assay for SARS-CoV-2. The study also assessed secondary outcomes related to usability and interpretability of test results among POC device operators. The study was designed to determine whether the POC device could provide reliable, accurate, and user-friendly testing results in decentralized settings. No device performance data were included in the dataset.

Outcome/Impact: The intended outcome of the study was to validate the POC platform for broader use, supporting regulatory expansion of its EUA for asymptomatic testing and self-collected samples.