SARS-CoV-2 InfectionNCT06191393
SARS-CoV-2 and Influenza A/B in Point-of-Care and Non-Laboratory Settings
A study testing Aptitude Medical Systems Metrix COVID/Flu Test in people with SARS-CoV-2 Infection and Influenza A, run by Aptitude Medical Systems at 3 sites in United States.
Trial summary
The Metrix COVID/Flu 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. Read more about this study
- Who is it for?
- Ages 2 years and older
- Conditions the study is for
- SARS-CoV-2 Infection, Influenza A, Influenza B
- What is being tested?
- Aptitude Medical Systems Metrix COVID/Flu Test
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 614 participants
- Where
- 3 sitesUnited States
- Study dates
- 20 Nov 2023to 11 Mar 2025
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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 associated with COVID-19 and/or influenza (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 has not eaten, consumed a beverage, smoked, brushed their teeth, gargled with mouth wash, or chewed gum for 30 minutes prior to collecting a saliva sample.
- Participant or guardian agrees to read, and is able to read with understanding, each of the saliva and/or AN swab QRI prior to beginning the operation of each of the Metrix COVID/Flu Test.
- Participant or guardian is able and willing to contribute the required saliva and/or swab samples for testing and understands and is able and willing to sign the study informed consent.
Who cannot join
- 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 saliva or nasal swab collection requirements following the QRI.
- Participant has previously provided a sample for the study.
- Participant has had seasonal influenza and/or the SARS-CoV-2 vaccine within the past 5 days.
- 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®).
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- 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.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
American Family Care
Chelmsford, Massachusetts, 01824
Central Coast Laboratories
Goleta, California, 93117
American Family Care
Trussville, Alabama, 35235
About this study
Official title: Clinical Validation of the Aptitude Medical Systems Metrix COVID/Flu Test for Detection of SARS-CoV-2 and Influenza A/B in Point-of-Care and Non-Laboratory Settings
The Metrix COVID/Flu 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/Flu Test for the differential detection of SARS-CoV-2, Influenza A, and Influenza B in AN swab or saliva 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. One or more investigational sites outside of the US (at which participants are required to be fluent in English) may also be included in the study depending on enrollment needs and geographical/seasonal 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, Flu A, and/or Flu B.
Read the detailed description
The Metrix COVID/Flu 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 COVID/Flu Test for the differential detection of SARS-CoV-2, Influenza A, and Influenza B in AN swab or saliva 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. One or more investigational sites outside of the US (at which participants are required to be fluent in English) may also be included in the study depending on enrollment needs and geographical/seasonal 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, Flu A, and Flu B.
The candidate device, Metrix COVID/Flu Test, will be evaluated with two specimen types - saliva and AN swab. Each Metrix COVID/Flu Test kit contains all supplies needed to test either a saliva or AN swab sample, including a corresponding QRI for each specimen type. It is possible for participants to elect to provide only a single sample type for the study; however, both sample types should be collected when possible. If participants will be testing both saliva and AN swab samples, the AN swab test should be conducted first. If participants elect to provide only a single sample type, the AN swab will be prioritized.
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, Flu A, and Flu B assay according to the IFU and will serve as the primary comparator for both saliva and AN swab samples. An additional saliva sample will also be obtained for SARS-CoV-2 analysis via a secondary comparator method, which will be used for informational purposes only. 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 COVID/Flu Test (investigational test) will be compared to the test results generated from the comparator assay.
No investigational test results will be reported to a third party or used for any treatment decisions.
Results from this study will be used in support of an Emergency Use Authorization approval from the FDA.
This work is supported by funding provided by the Biomedical Advanced Research and Development Authority (BARDA), contract number 75A50123C00013.
- Conditions
- SARS-CoV-2 Infection, Influenza A, Influenza B
- Being tested
- Aptitude Medical Systems Metrix COVID/Flu Test
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aptitude Medical Systems Metrix COVID/Flu TestDiagnostic test
The Metrix COVID/Flu 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, and Influenza B via electrochemical detection using the Metrix Reader. Detection of SARS-CoV-2 gene targets will produce a positive SARS-CoV-2 result, detection of the Flu A gene target will produce a positive Flu A result, and detection of the Flu B gene target will produce a positive Flu B 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Diagnostic Test: Aptitude Medical Systems Metrix COVID/Flu Test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Qualitative Detection of RNA From SARS-CoV-2, Influenza A, and Influenza B ; Positive Percent Agreement Performance Comparison of Candidate Device (Metrix) vs FDA-Cleared Comparator Assay
Qualitative detection of RNA from SARS-CoV-2, Influenza A, and Influenza B in unprocessed saliva and/or AN swab samples. The primary objective is to evaluate the performance (positive percent agreement, negative percent agreement, and 95% confidence intervals) of the Metrix COVID/Flu Test for qualitative, differential detection of SARS-CoV-2, Influenza A, and/or Influenza B RNA using AN swab and saliva samples. Comparator testing will determine the infection status of each sample for comparison to the candidate test. The primary comparator will be an FDA-cleared assay that detects SARS-CoV-2, Flu A, and Flu B. Positive Percent Agreement (PPA) is the number of positive specimens identified by the candidate test divided by the total true positives per the comparator.
Measured: 45 minutes
Qualitative Detection of RNA From SARS-CoV-2, Influenza A, and Influenza B ; Negative Percent AgreementPerformance Comparison of Candidate Device (Metrix) vs FDA-Cleared Comparator Assay
Qualitative detection of RNA from SARS-CoV-2, Influenza A, and Influenza B in unprocessed saliva and/or AN swab samples. The primary objective is to evaluate the performance (positive percent agreement, negative percent agreement, and 95% confidence intervals) of the Metrix COVID/Flu Test for qualitative, differential detection of SARS-CoV-2, Influenza A, and/or Influenza B RNA using AN swab and saliva samples. Comparator testing will determine the infection status of each sample for comparison to the candidate test. The primary comparator will be an FDA-cleared assay that detects SARS-CoV-2, Flu A, and Flu B. Negative Percent Agreement (NPA) is the number of negative specimens identified by the candidate test divided by the total true negatives per the comparator.
Measured: 45 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2024
- Study start20 Nov 2023
- Primary completion3 Mar 2024
- Study completion11 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for SARS-CoV-2 InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 614 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aptitude Medical Systems
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Biomedical Advanced Research and Development Authority
- Responsible party
- Sponsor
- Investigators
- Qin Yang, PhD, Principal investigator, Aptitude Medical Systems
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06191393
- Sponsor's protocol ID
- TP-23-003
- Status last verified
- Apr 2025
- First submitted
- 25 Aug 2023
- Last updated
- 13 May 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Validation of the Aptitude Medical Systems Metrix COVID/Flu Test for Detection of SARS-CoV-2 and Influenza A/B in Point-of-Care and Non-Laboratory Settings
- ClinicalTrials.gov ID
- NCT06191393
- Acronym / sponsor ID
- TP-23-003
- Conditions
- SARS-CoV-2 Infection, Influenza A, Influenza B
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 614 participants (actual)
- Lead sponsor
- Aptitude Medical SystemsIndustry (pharma, biotech, devices)
- Collaborators
- Biomedical Advanced Research and Development Authority
- Study start
- 20 Nov 2023 (actual)
- Primary completion
- 3 Mar 2024 (actual)
- Study completion
- 11 Mar 2025 (actual)
- First posted
- 5 Jan 2024 (actual)
- Results
- Posted 13 May 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The Metrix COVID/Flu 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/Flu Test for the differential detection of SARS-CoV-2, Influenza A, and Influenza B in AN swab or saliva 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. One or more investigational sites outside of the US (at which participants are required to be fluent in English) may also be included in the study depending on enrollment needs and geographical/seasonal 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, Flu A, and/or Flu B.
Detailed description
The Metrix COVID/Flu 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 COVID/Flu Test for the differential detection of SARS-CoV-2, Influenza A, and Influenza B in AN swab or saliva 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. One or more investigational sites outside of the US (at which participants are required to be fluent in English) may also be included in the study depending on enrollment needs and geographical/seasonal 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, Flu A, and Flu B.
The candidate device, Metrix COVID/Flu Test, will be evaluated with two specimen types - saliva and AN swab. Each Metrix COVID/Flu Test kit contains all supplies needed to test either a saliva or AN swab sample, including a corresponding QRI for each specimen type. It is possible for participants to elect to provide only a single sample type for the study; however, both sample types should be collected when possible. If participants will be testing both saliva and AN swab samples, the AN swab test should be conducted first. If participants elect to provide only a single sample type, the AN swab will be prioritized.
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, Flu A, and Flu B assay according to the IFU and will serve as the primary comparator for both saliva and AN swab samples. An additional saliva sample will also be obtained for SARS-CoV-2 analysis via a secondary comparator method, which will be used for informational purposes only. 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 COVID/Flu Test (investigational test) will be compared to the test results generated from the comparator assay.
No investigational test results will be reported to a third party or used for any treatment decisions.
Results from this study will be used in support of an Emergency Use Authorization approval from the FDA.
This work is supported by funding provided by the Biomedical Advanced Research and Development Authority (BARDA), contract number 75A50123C00013.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| OTC Study | Experimental | Diagnostic Test: Aptitude Medical Systems Metrix COVID/Flu TestThis 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. |
Who may qualify
- Ages
- 2 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- 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 associated with COVID-19 and/or influenza (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 has not eaten, consumed a beverage, smoked, brushed their teeth, gargled with mouth wash, or chewed gum for 30 minutes prior to collecting a saliva sample.
- Participant or guardian agrees to read, and is able to read with understanding, each of the saliva and/or AN swab QRI prior to beginning the operation of each of the Metrix COVID/Flu Test.
Key exclusion criteria (10 listed)
- 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 saliva or nasal swab collection requirements following the QRI.
- Participant has previously provided a sample for the study.
- Participant has had seasonal influenza and/or the SARS-CoV-2 vaccine within the past 5 days.
- Participant is not able to tolerate sample collection.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Aptitude Medical Systems Metrix COVID/Flu TestThe Metrix COVID/Flu 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, and Influenza B via electrochemical detection using the Metrix Reader. Detection of SARS-CoV-2 gene targets will produce a positive SARS-CoV-2 result, detection of the Flu A gene target will produce a positive Flu A result, and detection of the Flu B gene target will produce a positive Flu B 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. | Diagnostic test | OTC Study |
Primary outcome
Qualitative Detection of RNA From SARS-CoV-2, Influenza A, and Influenza B ; Positive Percent Agreement Performance Comparison of Candidate Device (Metrix) vs FDA-Cleared Comparator Assay
Time frame: 45 minutes
Qualitative detection of RNA from SARS-CoV-2, Influenza A, and Influenza B in unprocessed saliva and/or AN swab samples. The primary objective is to evaluate the performance (positive percent agreement, negative percent agreement, and 95% confidence intervals) of the Metrix COVID/Flu Test for qualitative, differential detection of SARS-CoV-2, Influenza A, and/or Influenza B RNA using AN swab and saliva samples. Comparator testing will determine the infection status of each sample for comparison to the candidate test. The primary comparator will be an FDA-cleared assay that detects SARS-CoV-2, Flu A, and Flu B. Positive Percent Agreement (PPA) is the number of positive specimens identified by the candidate test divided by the total true positives per the comparator.
Qualitative Detection of RNA From SARS-CoV-2, Influenza A, and Influenza B ; Negative Percent AgreementPerformance Comparison of Candidate Device (Metrix) vs FDA-Cleared Comparator Assay
Time frame: 45 minutes
Qualitative detection of RNA from SARS-CoV-2, Influenza A, and Influenza B in unprocessed saliva and/or AN swab samples. The primary objective is to evaluate the performance (positive percent agreement, negative percent agreement, and 95% confidence intervals) of the Metrix COVID/Flu Test for qualitative, differential detection of SARS-CoV-2, Influenza A, and/or Influenza B RNA using AN swab and saliva samples. Comparator testing will determine the infection status of each sample for comparison to the candidate test. The primary comparator will be an FDA-cleared assay that detects SARS-CoV-2, Flu A, and Flu B. Negative Percent Agreement (NPA) is the number of negative specimens identified by the candidate test divided by the total true negatives per the comparator.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Qin Yang, PhD principal investigator
Aptitude Medical Systems
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Aptitude Medical Systems Metrix COVID/Flu Test in people with SARS-CoV-2 Infection and Influenza A, run by Aptitude Medical Systems at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 13 May 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Qualitative Detection of RNA From SARS-CoV-2, Influenza A, and Influenza B ; Positive Percent Agreement Performance Comparison of Candidate Device (Metrix) vs FDA-Cleared Comparator Assay (time frame: 45 minutes). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 May 2025.