At a glance
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Clinical Validation of the Aptitude Medical Systems Metrix COVID/Flu Test for Detection of SARS-CoV-2 and Influenza A/B in Point-of-Care and Non-Laboratory Settings
In Brief
A clinical study evaluating Aptitude Medical Systems Metrix COVID/Flu Test for SARS-CoV-2 Infection and 2 related conditions. Completed, enrolled 614 participants across 3 sites.
Detailed Summary
The Metrix COVID/Flu 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/Flu Test for the differential detection of SARS-CoV-2, Influenza A, and Influenza B in AN swab or saliva 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. One or more investigational sites outside of the US (at which participants are required to be fluent in English) may also be included in the study depending on enrollment needs and geographical/seasonal 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, Flu A, and/or Flu B.
Study Details
Timeline
Interventions
The Metrix COVID/Flu Test is a real-time reverse transcription loop-mediated isothermal amplification reaction (RT-LAMP) test that has been designed to detect viral RNA from SARS-CoV-2, Influenza A, and Influenza B via electrochemical detection using the Metrix Reader. Detection of SARS-CoV-2 gene targets will produce a positive SARS-CoV-2 result, detection of the Flu A gene target will produce a positive Flu A result, and detection of the Flu B gene target will produce a positive Flu B result. If no target is detected and the internal control amplifies, the result is negative. If no amplification is detected in any of the channels, an invalid result is displayed.