An interventional study of Aptitude Medical Systems Respiratory Panel Test in COVID -19, Influenza A and Influenza B, sponsored by Aptitude Medical Systems. Not yet recruiting at 1 site in United States. Per ClinicalTrials.gov, last updated 2025-10-16.
Sponsored by Aptitude Medical Systems · Not applicable, Interventional, and Diagnostic
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.
The Metrix Respiratory Panel Test will be evaluated for OTC use in a home use 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 differential detection of SARS-CoV-2, Influenza A, Influenza B, Respiratory syncytial virus, and Rhinovirus in 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 detection of SARS-CoV-2, Influenza A, Influenza B, Respiratory syncytial virus, and Rhinovirus.
The candidate device, Metrix Respiratory Panel Test, will be evaluated with AN swab sample types. Each Metrix Respiratory Panel Test kit contains all supplies needed to test AN swab samples, including a corresponding QRI for detailed instructions.
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.
For each participant, a comparator NP swab sample will be obtained by a healthcare practitioner after testing with the candidate device. This NP swab will be tested with the FDA-cleared SARS-CoV-2 assay according to the IFU and will serve as the primary comparator for swab samples. An additional AN swab sample will be collected and stored frozen and dry for later analysis to support future research validation studies.
No results from the investigational test or comparator testing will be used for clinical diagnosis, management of study participants, or to make treatment decisions.
Test results from the Metrix Respiratory Panel Test (investigational test) will be compared to the test results generated from the comparator assay.
No investigational test results will be used for any treatment decisions.
This work is supported by funding provided by the Biomedical Advanced Research and Development Authority (BARDA).
7,638 studies on the registry are indexed under COVID-19; 488 are open to participants now.
This study's planned enrollment of 2,000 is above the median of 100 across 4,098 interventional studies indexed under COVID-19.
Browse COVID-19 studies →Aptitude Medical Systems is the lead sponsor of 3 studies on the registry; 2 are open to participants now.
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Exclusion Criteria:
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
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.
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.
Time frame: 25 minutes
Plan to share: No
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