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

Launched by APTITUDE MEDICAL SYSTEMS · Dec 18, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new COVID-19 test called the Metrix COVID Test. The goal is to see how well this test works when used at home or in places like urgent care clinics. Participants will provide nasal swab samples, which will be tested for the virus that causes COVID-19 (SARS-CoV-2). The study is taking place at several locations in the United States, and researchers will compare the results from the Metrix test to those from an established test that has already been approved by the FDA.

To be eligible for this study, participants must be at least 2 years old and currently showing symptoms of a respiratory infection, such as a cough, fever, or loss of taste or smell. Participants or their guardians need to be willing to give consent and understand the testing process. It's important to note that people currently undergoing certain antiviral treatments or who have had recent nasal procedures may not qualify. Those interested in taking part can expect to provide a nasal swab sample and receive guidance on how the test works. This trial aims to help improve COVID-19 testing options for everyone.

Gender

ALL

Eligibility 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.