Madison

Researchers are evaluating the Metrix COVID Test for use in point-of-care and home (over-the-counter) settings to detect SARS-CoV-2, the virus causing COVID-19. This prospective study is conducted at three or more investigational sites in the United States, using simulated home environments set up near clinical settings like urgent care facilities. The study focuses on symptomatic participants aged 2 years and older and aims to clinically validate the Metrix COVID Test by comparing it to an FDA-cleared assay for SARS-CoV-2 detection using anterior nasal (AN) swab samples. The study evaluates the Metrix COVID Test, a real-time reverse transcription loop-mediated isothermal amplification (RT-LAMP) test that detects viral RNA of SARS-CoV-2 via electrochemical detection with the Metrix Reader. Participants or their guardians will self-collect AN swab samples using kits containing all supplies and detailed instructions. After testing with the Metrix COVID Test, a healthcare practitioner collects a nasopharyngeal (NP) swab for comparator testing with an FDA-cleared assay. Additional AN swab samples will be stored for future research. The study includes only symptomatic subjects and may add more sites to meet enrollment and geographic needs. Participants will provide informed consent and collect swab samples under study guidelines. Samples will be coded for confidentiality and tested both by the investigational Metrix COVID Test and the comparator assay. No test results will be used for clinical diagnosis or treatment decisions. Researchers will measure the qualitative detection of viral RNA from SARS-CoV-2 and compare positive/negative agreement between tests, with results available in about 25 minutes. The study is funded by the Biomedical Advanced Research and Development Authority (BARDA).