Validation Study of the Aptitude Medical Systems Metrix COVID Test for Detecting SARS-CoV-2 in Point-of-Care and Home Settings

What this Trial Is About

Researchers are evaluating the Aptitude Medical Systems Metrix COVID Test to detect SARS-CoV-2 infection using anterior nasal AN swab samples in a home-like testing environment. This study focuses on symptomatic individuals aged 2 years and older and compares the Metrix COVID Test results to those obtained from an FDA-cleared assay for SARS-CoV-2 detection. The study is prospective and conducted at multiple investigational sites in the United States, including simulated home settings near clinical facilities such as urgent care centers. The Metrix COVID Test is a diagnostic test based on real-time reverse transcription loop-mediated isothermal amplification RT-LAMP with electrochemical detection via the Metrix Reader. Participants or their guardians will self-collect AN swab samples for testing, while healthcare practitioners will collect comparator nasopharyngeal NP swab samples. Each participants sample will be coded for confidentiality. The study involves only symptomatic subjects, and no test results from either method will be used for clinical diagnosis or treatment decisions. During participation, subjects will provide swab samples and follow detailed instructions provided in the kits quick reference guide. Researchers will measure the qualitative detection of SARS-CoV-2 RNA and compare positive and negative agreement rates between the Metrix COVID Test and the FDA-cleared comparator assay within 25 minutes. Participant confidentiality is maintained throughout, and no investigational test results will be reported to third parties. The study is supported by the Biomedical Advanced Research and Development Authority BARDA.

Clinical Validation of the Aptitude Medical Systems Metrix COVID-19 Test