The Metrix Respiratory Panel Test will be evaluated for use in Non-Laboratory settings ina home testing environment utilizing the clinical study design described herein. Thestudy will take place in simulated home environments which will be set up within or nearactive clinical settings (e.g., urgent care facilities). This will be a prospective studyconducted at three or more investigational sites located within the United States for theclinical 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 minimumsubject/sample enrollment requirements and geographic prevalence of respiratory virusinfections. Comparator testing will be performed to determine the infection status ofeach sample for comparison to results generated by the candidate test. The primarycomparator 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).
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.
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. 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.
3. 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.
4. 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.
5. Participant is willing to provide all samples and run tests for the specified
investigational devices.
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 Quick Reference Instructions (QRI).
3. Participant is not currently exhibiting respiratory tract infection symptoms.
4. Participant has previously participated in the study.
5. Participant is not able to tolerate specimen collection.
6. 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.
7. 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®).
8. 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®).
9. 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.
10. Participants who have had recent craniofacial injury or surgery, including to
correct deviation of the nasal septum, within the previous six (6) months.
11. Participants who do not understand/read the English language.
AFC Trussville
Trussville 4094212, Alabama 4829764, United States
Investigator: Brad Killingsworth, M.A.
Contact: 2814674855
clinicaltrials@aptitudemedical.com
Brad W Killingsworth, M.A.
2814674855
clinicaltrials@aptitudemedical.com
Tyler Chozinski, PhD
clinicaltrials@aptitudemedical.com
Brad W Killingsworth, M.A., Principal Investigator
Aptitude Medical Systems, Inc