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

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
Aptitude Medical Systems
Study ID
NCT06744660
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
2 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • Aptitude Medical Systems Metrix COVID Test — DIAGNOSTIC_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.

Study Details

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.

Key Dates

Start date
Oct 17, 2024
Status verified
Sep 2025
Primary completion
Sep 18, 2025
Completion
Dec 1, 2025

Study Design

Enrollment
1,000 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC

Arms

  • Experimental: OTC Study
    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.

Primary Outcome Measure

Qualitative detection of RNA from SARS-CoV-2 and Measurement of Positive/Negative Percent Agreement with FDA-cleared comparator test [ Time Frame: 25 minutes ]

Central Contacts

Locations (3)

FacilityCityStateZIPSite coordinators
AFC MontclairBirminghamAlabama35210
Brad Killingsworth
[email protected]
2814674855
AFC MadisonMadisonAlabama35758
Brad Killingsworth
[email protected]
2814674855
PPU Mid CityBaton RougeLouisiana70802
Brad Killingsworth
[email protected]
2814674855

Find similar trials in Birmingham, AL

By condition
COVID-19 / long COVID
By specialty
Infectious disease
By research site
AFC Montclair· Birmingham, ALAFC Madison· Madison, ALPPU Mid City· Baton Rouge, LA

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