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

NCT06744660 | Recruiting FDA Device

• 1 other identifier: TP-24-028
• Study Type: interventional
• Target: 1,000
• Locations: 1 country
• Sites: 3

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

Outcome Measures

Primary Outcomes (1)

• Qualitative detection of RNA from SARS-CoV-2 and Measurement of Positive/Negative Percent Agreement with FDA-cleared comparator test

  Qualitative detection of RNA from SARS-CoV-2 in unprocessed AN swab samples. Primary objective of this study is to evaluate the performance (positive percent agreement, negative percent agreement and 95% confidence intervals for upper and lower bounds) of the Metrix COVID/Flu Test for the qualitative detection of SARS-CoV-2 viral RNA using AN swab samples. Comparator testing will be performed to determine the status of each sample for comparison to results produced by the candidate test. 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 that detects SARS-CoV-2.

  25 minutes

Study Arms (1)

OTC Study

EXPERIMENTAL

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.

Diagnostic Test: Aptitude Medical Systems Metrix COVID Test

Interventions

Aptitude Medical Systems Metrix COVID Test DIAGNOSTIC_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.

OTC Study

Eligibility Criteria

• Age: 2 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Aptitude Medical Systems: lead
• Biomedical Advanced Research and Development Authority: collaborator

Study Sites (3)

AFC Montclair

Birmingham, Alabama, 35210, United States

RECRUITING

AFC Madison

Madison, Alabama, 35758, United States

RECRUITING

PPU Mid City

Baton Rouge, Louisiana, 70802, United States

RECRUITING

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Central Study Contacts

Brad Killingsworth, M.A.

CONTACT

281-467-4855; clinicaltrials@aptitudemedical.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 13, 2024
• First Posted: December 20, 2024
• Study Start: October 17, 2024
• Primary Completion: September 18, 2025
• Study Completion: December 1, 2025
• Last Updated: October 2, 2025

Record last verified: 2025-09

Locations

US (3)