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

Part of paid clinical trials in Trussville, Alabama.

Sponsor
Aptitude Medical Systems
Study ID
NCT07217639
Status
Not Yet Recruiting

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Conditions

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

Eligibility Criteria

Sex
ALL
Age
N/A - N/A
Healthy Volunteers
Not accepted

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.

Study Details

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.

Key Dates

Start date
Nov 1, 2025
Status verified
Oct 2025
Primary completion
Apr 1, 2026
Completion
Sep 1, 2026

Study Design

Enrollment
2,000 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC

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.

Primary Outcome Measure

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 [ Time Frame: 25 minutes ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
AFC TrussvilleTrussvilleAlabama35235
Brad Killingsworth, M.A.
[email protected]
2814674855

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AFC Trussville· Trussville, AL

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