NCT06744660

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

Clinical Validation of the Aptitude Medical Systems Metrix COVID-19 Test for Detection of SARS-CoV-2 in Point-of-Care and At-Home (OTC)/Non-Laboratory Settings

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 1,000 (estimated)
• Sponsor: Aptitude Medical Systems · Industry
• Sex: All
• Age: 2 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

The Metrix COVID Test will be evaluated for OTC use in a home use 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 differential detection of SARS-CoV-2 in 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 detection of SARS-CoV-2. The candidate device, Metrix COVID Test, will be evaluated with AN swab sample types. Each Metrix COVID Test kit contains all supplies needed to test AN swab samples, including a corresponding QRI for detailed instructions. This OTC study will take place in simulated home environments which will be set up within or near clinical settings (e.g., urgent care facilities). The study will enroll symptomatic subjects only. Candidate samples will be self-collected by participants (or collected by a guardian for participants under the age of 14 years) and comparator samples will be collected by a healthcare practitioner with informed consent and Institutional Review Board (IRB) approval. Each sample will be coded for confidentiality. For each participant, a comparator NP swab sample will be obtained by a healthcare practitioner after testing with the candidate device. This NP swab will be tested with the FDA-cleared SARS-CoV-2 assay according to the IFU and will serve as the primary comparator for swab samples. An additional AN swab sample will be collected and stored frozen and dry for later analysis to support future research validation studies. No results from the investigational test or comparator testing will be used for clinical diagnosis, management of study participants, or to make treatment decisions. Test results from the Metrix COVID Test (investigational test) will be compared to the test results generated from the comparator assay. No investigational test results will be reported to a third party or used for any treatment decisions. This work is supported by funding provided by the Biomedical Advanced Research and Development Authority (BARDA).

Conditions

• COVID-19
• COVID

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Aptitude Medical Systems Metrix COVID Test	The Metrix COVID 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 via electrochemical detection using the Metrix Reader. Detection of SARS-CoV-2 gene targets will produce a positive SARS-CoV-2 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.

Timeline

• Start date: 2024-10-17
• Primary completion: 2025-09-18
• Completion: 2025-12-01
• First posted: 2024-12-20
• Last updated: 2025-10-02

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated device study