Actively Recruiting
Clinical Validation of the Aptitude Medical Systems Metrix COVID-19 Test
Led by Aptitude Medical Systems · Updated on 2025-10-02
1000
Participants Needed
3
Research Sites
58 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
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.
CONDITIONS
Official 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 able and willing to provide written informed consent, and assent where applicable, prior to study enrollment.
- Male or female aged 2 years or older
- Participant is currently exhibiting fever, or one or more symptoms of respiratory tract infection (such as, but not limited to, chills, cough, shortness of breath or difficulty breathing, fatigue, new loss of taste or smell, sore throat, congestion or runny nose, nausea or vomiting or diarrhea). Participant must still be exhibiting symptoms on the day of sample collection.
- Participant or guardian agrees to read, and is able to read with understanding, the AN swab QRI prior to beginning the operation of each of the Metrix COVID-19 Test.
- Participant or guardian is able and willing to contribute the required swab samples for testing and understands and is able and willing to sign the study informed consent.
You will not qualify if you...
- Participant does not understand and/or is not able and willing to sign the study informed consent and/or assent.
- Participant or guardian is not able to comply with nasal swab collection requirements following the QRI.
- Participant has previously provided a sample for the study.
- Participant is not able to tolerate sample collection.
- Participant is currently undergoing antiviral treatment such as baloxavir marboxil (Xofluza), oseltamivir (Tamiflu), zanamivir (Relenza), or peramivir (Rapivab).
- Participants currently undergoing treatment and/or within the past 30 days with prescription medication to treat novel Coronavirus SARS-CoV-2 infection, including but not limited to Remdesivir (Veklury), Paxlovid, molnupiravir, or receiving convalescent plasma therapy for SARS-CoV-2.
- Participants who have had a nasal wash or aspirate as part of their standard care treatment on day of study visit prior to study sample collection.
- Participants who have had recent craniofacial injury or surgery, including correction of nasal septum deviation, within the past 6 months.
- Participants who do not understand or read the English language.
AI-Screening
AI-Powered Screening
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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.
CONTACT
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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