Recruiting

Metrix COVID-19 Test

Sponsor:

Aptitude Medical Systems

Code:

NCT06744660

Conditions

COVID-19

COVID

Eligibility Criteria

Sex: All

Age: 2+

Healthy Volunteers: Accepted

Interventions

Aptitude Medical Systems Metrix COVID Test

Study Details

Brief 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.

Conditions

COVID-19

COVID

Study ID

NCT06744660

Start date

Oct 17, 2024

Status verified date

Sep, 2025

Completion date

Dec 1, 2025

Anticipated

Primary completion date

Sep 18, 2025

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 2+

Healthy Volunteers: Accepted

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.

Study Design

Enrollment

1000 participants

Anticipated

Intervention Model

Single group

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

experimental: OTC Study

This OTC study will take place in simulated home environments which will be set up within or near clinical settings (e.g., urgent care facilities). The study will enroll symptomatic subjects only. Candidate samples will be self-collected by participants (or collected by a guardian for participants under the age of 14 years) and comparator samples will be collected by a healthcare practitioner with informed consent and Institutional Review Board (IRB) approval. Each sample will be coded for confidentiality.

Interventions

Aptitude 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.

Primary outcome measure

  • Qualitative detection of RNA from SARS-CoV-2 and Measurement of Positive/Negative Percent Agreement with FDA-cleared comparator test [ Time Frame: 25 minutes ]

Central Contacts and Locations

Central contacts

Brad Killingsworth, M.A.

281-467-4855clinicaltrials@aptitudemedical.com

Locations

AFC Montclair

Recruiting

Birmingham, Alabama, United States, 35210

Contacts

Brad Killingsworth

2814674855clinicaltrials@aptitudemedical.com

AFC Madison

Recruiting

Madison, Alabama, United States, 35758

Contacts

Brad Killingsworth

2814674855clinicaltrials@aptitudemedical.com

PPU Mid City

Recruiting

Baton Rouge, Louisiana, United States, 70802

Contacts

Brad Killingsworth

2814674855clinicaltrials@aptitudemedical.com

More Information

Sponsor

Aptitude Medical Systems

Last update posted

Oct 2, 2025

Last verified

Sep, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Aptitude Medical Systems on 2025-10-02.