Actively Recruiting
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
Led by Aptitude Medical Systems · Updated on 2025-10-02
1000
Participants Needed
3
Research Sites
10 weeks
Total Duration
On this page
Sponsors
A
Aptitude Medical Systems
Lead Sponsor
B
Biomedical Advanced Research and Development Authority
Collaborating Sponsor
AI-Summary
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 participant's 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 kit's 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).
CONDITIONS
Brief Title
Clinical Validation of the Aptitude Medical Systems Metrix COVID-19 Test
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participant or guardian understands and is willing to provide written informed consent and assent where applicable prior to enrollment
- Male or female aged 2 years or older
- Currently exhibiting fever or one or more symptoms of respiratory tract infection on the day of sample collection
- Able to read and understand the anterior nasal swab quick reference instructions prior to testing
- Willing and able to provide required swab samples and sign informed consent
You will not qualify if you...
- Unable or unwilling to sign informed consent and/or assent
- Unable to comply with nasal swab collection requirements
- Previously provided a sample for this study
- Unable to tolerate sample collection
- Currently undergoing antiviral treatment such as baloxavir marboxil, oseltamivir, zanamivir, or peramivir
- Currently or within past 30 days treated with prescription medications for COVID-19 including Remdesivir, Paxlovid, molnupiravir, or convalescent plasma therapy
- Had a nasal wash or aspirate on day of study visit before sample collection
- Recent craniofacial injury or nasal surgery within the previous 6 months
- Does not understand or read English language
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 1 day
Participants self-collect anterior nasal swab samples in simulated home environments and have additional nasal swab samples collected by a healthcare practitioner for comparison testing.
1 visit (in-person)
Trial Site Locations
Total: 3 locations
1
AFC Montclair
Birmingham, Alabama, United States, 35210
Actively Recruiting
2
AFC Madison
Madison, Alabama, United States, 35758
Actively Recruiting
3
PPU Mid City
Baton Rouge, Louisiana, United States, 70802
Actively Recruiting
Research Team
B
Brad Killingsworth, M.A.
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
DIAGNOSTIC
Number of Arms
1
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