RecruitingNot ApplicableNCT06744660

Clinical Validation of the Aptitude Medical Systems Metrix 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

Sponsor

Aptitude Medical Systems

Enrollment

1,000 participants

Start Date

Oct 17, 2024

Study Type

INTERVENTIONAL

Conditions

COVID-19 COVID

Summary

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.

Eligibility

Min Age: 2 Years

Inclusion Criteria5

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.

Exclusion Criteria9

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 (trade name Xofluza®), oseltamivir (Tamiflu®), zanamivir (Relenza®), and peramivir (Rapivab®).
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.
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.

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Interventions

DIAGNOSTIC_TESTAptitude Medical Systems Metrix COVID Test

The Metrix COVID Test is a real-time reverse transcription loop-mediated isothermal amplification reaction (RT-LAMP) test that has been designed to detect viral RNA from SARS-CoV-2 via electrochemical detection using the Metrix Reader. Detection of SARS-CoV-2 gene targets will produce a positive SARS-CoV-2 result. If no target is detected and the internal control amplifies, the result is negative. If no amplification is detected in any of the channels, an invalid result is displayed.