Status:
NOT_YET_RECRUITING
Clinical Validation of the Aptitude Medical Systems Metrix Respiratory Panel Test in At-Home/Non-Laboratory Settings
Lead Sponsor:
Aptitude Medical Systems
Conditions:
COVID -19
Influenza A
Eligibility:
All Genders
Phase:
NA
Brief Summary
The Metrix Respiratory Panel Test will be evaluated for use in Non-Laboratory settings in a home testing environment utilizing the clinical study design described herein. The study will take place in ...
Detailed Description
The Metrix Respiratory Panel 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 envi...
Eligibility Criteria
Inclusion
- Participant or guardian understands and is able and willing to provide written informed consent, and assent where applicable, prior to study enrollment.
- Participant is currently exhibiting signs/symptoms of respiratory tract infection including but not limited to fever, cough, sore throat, runny nose, myalgia, headache, chills, new loss of taste or smell, or fatigue. Participant must still be exhibiting symptoms on the day of specimen collection. Days post symptom onset is not to exceed 14 days.
- Participant or guardian agrees to read, and is able to read with understanding, the Quick Reference Instructions (QRI) prior to beginning the execution of each of the tests.
- Participant or guardian is able and willing to contribute the required swab specimens for testing and understands and is able and willing to sign the study informed consent.
- Participant is willing to provide all samples and run tests for the specified investigational devices.
Exclusion
- 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 Quick Reference Instructions (QRI).
- Participant is not currently exhibiting respiratory tract infection symptoms.
- Participant has previously participated in the study.
- Participant is not able to tolerate specimen collection.
- Participant is currently undergoing or has within the past thirty (30) days undergone treatment with prescription medication to treat SARS-CoV-2 infection, including but not limited to Remdesivir (Veklury®), Nirmatrelvir/Ritonavir (Paxlovid®), Molnupiravir (LagevrioTM) or receiving convalescent plasma therapy for SARS-CoV- 2.
- Participant is currently undergoing or has within the past thirty (30) days undergone an inhaled influenza vaccine (FluMist®), or antiviral treatment, including but not limited to Amantadine (Symmetrel®), Rimantadine (Flumadine®), Zanamivir (Relenza®), Oseltamivir (Tamiflu®), Baloxavir Marboxil (Xofluza®), Amantadine (Symmetrel®), Rimantadine (Flumadine®), or Peramivir (Rapivab®).
- Participant is currently undergoing or has within the past thirty (30) days undergone antiviral treatment for RSV, including but not limited to Ribavirin (Virazole®), RSV-IGIV (RespiGam®), Palivizumab (Synagis®), or Nirsevimab-alip (Beyfortus®).
- 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.
- Participants who have had recent craniofacial injury or surgery, including to correct deviation of the nasal septum, within the previous six (6) months.
- Participants who do not understand/read the English language.
Key Trial Info
Start Date :
November 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2026
Estimated Enrollment :
2000 Patients enrolled
Trial Details
Trial ID
NCT07217639
Start Date
November 1 2025
End Date
September 1 2026
Last Update
October 16 2025
Active Locations (1)
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1
AFC Trussville
Trussville, Alabama, United States, 35235