Clinical Validation of the Aptitude Medical Systems Metrix Respiratory Panel Test in At-Home/Non-Laboratory Settings

NCT07217639 | Not Yet Recruiting FDA Device

• 2 other identifiers: TP-25-04175A50123C00013
• Study Type: interventional
• Target: 2,000
• Locations: 1 country
• Sites: 1

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 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 Respiratory Panel Test for the detection of SARS-CoV-2, Influenza A, Influenza B, Respiratory syncytial virus, and Rhinovirus in anterior nares (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, Influenza A, Influenza B, Respiratory Syncytial Virus, and Rhinovirus.

Conditions

COVID -19; Influenza A; Influenza B; Respiratory Synctial Virus; RSV; Rhinovirus

Outcome Measures

Primary Outcomes (1)

• Qualitative detection of RNA from SARS-CoV-2, Influenza A, Influenza B, Respiratory Syncytial Virus, and Rhinovirus, and Measurement of Positive/Negative Percent Agreement with FDA-cleared comparator test

  Qualitative detection of RNA from SARS-CoV-2, Influenza A, Influenza B, Respiratory Syncytial Virus, and Rhinovirus 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 Respiratory Panel Test for the qualitative detection of SARS-CoV-2, Influenza A, Influenza B, Respiratory Syncytial Virus, and Rhinovirus 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, Influenza A, Influenza B, Respiratory Syncytial Virus, and Rhinovirus.

  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 Respiratory Panel Test

Interventions

Aptitude Medical Systems Respiratory Panel Test DIAGNOSTIC_TEST

The Metrix Respiratory Panel 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, Influenza A, Influenza B, Respiratory Syncytial Virus, and Rhinovirus via electrochemical detection using the Metrix Reader. Detection of SARS-CoV-2, Influenza A, Influenza B, Respiratory Syncytial Virus, and Rhinovirus gene targets will produce a positive result, differentiated by each target. 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

• Sex: all
• Healthy Volunteers: No
• 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.
• 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.

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 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.

Sponsors & Collaborators

• Aptitude Medical Systems: lead

Study Sites (1)

AFC Trussville

Trussville, Alabama, 35235, United States

Location

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

Study Officials

• Brad W Killingsworth, M.A.

  Aptitude Medical Systems, Inc

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Brad W Killingsworth, M.A.

CONTACT

2814674855; clinicaltrials@aptitudemedical.com

Tyler Chozinski, PhD

CONTACT

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: October 14, 2025
• First Posted: October 16, 2025
• Study Start: November 1, 2025
• Primary Completion: April 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: October 16, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)