Validation of a home 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
NA · Aptitude Medical Systems · NCT06744660
This study is testing a new home COVID-19 test to see if it accurately detects the virus in people who have symptoms.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 1000 (estimated) |
| Ages | 2 Years and up |
| Sex | All |
| Sponsor | Aptitude Medical Systems (industry) |
| Locations | 3 sites (Birmingham, Alabama and 2 other locations) |
| Trial ID | NCT06744660 on ClinicalTrials.gov |
What this trial studies
The Metrix COVID Test will be evaluated for its effectiveness in detecting SARS-CoV-2 in a home testing environment. This prospective study will take place in simulated home settings near active clinical facilities, enrolling symptomatic participants aged 2 years and older. Participants will self-collect nasal swab samples, which will be compared against an FDA-cleared assay to determine the accuracy of the Metrix test. The study aims to validate the test's performance for over-the-counter use in non-laboratory settings.
Who should consider this trial
Good fit: Ideal candidates are symptomatic individuals aged 2 years or older exhibiting respiratory infection symptoms.
Not a fit: Patients who are asymptomatic or do not exhibit any respiratory infection symptoms will not benefit from this study.
Why it matters
Potential benefit: If successful, this test could provide a reliable and convenient method for individuals to detect COVID-19 at home.
How similar studies have performed: Other studies have shown success in validating home testing approaches for COVID-19, indicating potential for this method.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Participant or guardian understands and is able and willing to provide written informed consent, and assent where applicable, prior to study enrollment. 2. Male or female aged 2 years or older 3. 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. 4. 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. 5. 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. Exclusion Criteria: 1. Participant does not understand and/or is not able and willing to sign the study informed consent and/or assent. 2. Participant or guardian is not able to comply with nasal swab collection requirements following the QRI. 3. Participant has previously provided a sample for the study. 4. Participant is not able to tolerate sample collection. 5. Participant is currently undergoing antiviral treatment such as baloxavir marboxil (trade name Xofluza®), oseltamivir (Tamiflu®), zanamivir (Relenza®), and peramivir (Rapivab®). 6. Participants currently undergoing treatment and/or within the past thirty (30) days with prescription medication to treat novel Coronavirus SARS-CoV-2 infection, which may include but is not limited to Remdesivir (Veklury), Paxlovid, molnupiravir or receiving convalescent plasma therapy for SARS-CoV-2. 7. Participants who have had a nasal wash or aspirate as part of their standard of care treatment on day of study visit prior to the study sample collection. 8. Participants who have had recent craniofacial injury or surgery, including to correct deviation of the nasal septum, within the previous six (6) months. 9. Participants who do not understand/read the English language.
Where this trial is running
Birmingham, Alabama and 2 other locations
- AFC Montclair — Birmingham, Alabama, United States (RECRUITING)
- AFC Madison — Madison, Alabama, United States (RECRUITING)
- PPU Mid City — Baton Rouge, Louisiana, United States (RECRUITING)
Study contacts
- Study coordinator: Brad Killingsworth, M.A.
- Email: clinicaltrials@aptitudemedical.com
- Phone: 281-467-4855
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.