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

The Metrix COVID Test will be evaluated for use in Point-of-Care and Non-Laboratory settings in a home testing environment utilizing the clinical study design described herein. The study will take place in simulated home environments which will be set up within or near active clinical settings (e.g., urgent care facilities). This will be a prospective study conducted at three or more investigational sites located within the United States for the clinical validation of the Metrix COVID Test for the detection of SARS-CoV-2 AN swab samples. Additional sites may be added to the study in order to meet minimum subject/sample enrollment requirements and geographic prevalence of respiratory virus infections. Comparator testing will be performed to determine the infection status of each sample for comparison to results generated by the candidate test. The primary comparator for the study will be an FDA-cleared assay for the detection of SARS-CoV-2.

NCT Number	NCT06744660
Lead Sponsor	Aptitude Medical Systems Collaborators: Biomedical Advanced Research and Development Authority
Conditions	COVID-19, COVID
Enrollment	1,000 participants
Start Date	2024-10-17
Primary Completion	2025-09-18 (estimated)
Study Completion	2025-12-01 (estimated)
Updated on ClinicalTrials.gov	2025-10-02