614 Participants Needed

Metrix Test for COVID-19 and Flu

Recruiting at 2 trial locations
QY
TC
Overseen ByTyler Chozinski, PhD
Age: Any Age
Sex: Any
Trial Phase: Academic
Sponsor: Aptitude Medical Systems
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 1 JurisdictionThis treatment is already approved in other countries

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

If you are currently taking antiviral medications or treatments for COVID-19, you will need to stop these before participating in the trial. The trial excludes participants who are undergoing antiviral treatment or have taken certain COVID-19 medications in the past 30 days.

How does the Metrix Test for COVID-19 and Flu differ from other treatments?

The Metrix Test for COVID-19 and Flu is unique because it likely involves a point-of-care testing approach, which provides rapid results directly at the site of patient care, unlike traditional lab-based tests that require more time and resources. This can be particularly beneficial in remote or low-resourced settings where quick decision-making is crucial.12345

What data supports the effectiveness of the Metrix COVID/Flu Test treatment?

The research on point-of-care tests like the Abbott ID NOW and Lucira Check-It shows that these tests can quickly and accurately diagnose infections like flu and COVID-19, helping manage patient flow and reduce resource use in hospitals. This suggests that the Metrix COVID/Flu Test, which is also a point-of-care test, could be effective in providing timely and reliable results for COVID-19 and flu.46789

Who Is on the Research Team?

QY

Qin Yang, PhD

Principal Investigator

Aptitude Medical Systems

Are You a Good Fit for This Trial?

This trial is for individuals who can participate in a study to test the Metrix COVID/Flu Test, which detects SARS-CoV-2 and Influenza A/B. Participants will use the test in simulated home environments within or near clinical settings like urgent care facilities.

Inclusion Criteria

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 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.
I am at least 2 years old.
See 3 more

Exclusion Criteria

Participant is not able to tolerate sample collection.
I understand and am willing to sign the study consent form.
I've had the flu or COVID-19 vaccine in the last 5 days.
See 7 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Sample Collection and Testing

Participants self-collect samples (saliva or AN swab) for testing with the Metrix COVID/Flu Test. Comparator samples are collected by healthcare practitioners.

1 day
1 visit (in-person)

Comparator Testing

Comparator testing is performed to determine the infection status of each sample for comparison to results generated by the candidate test.

1 day

Follow-up

Participants are monitored for any adverse events and data is collected for analysis.

2 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Aptitude Medical Systems Metrix COVID/Flu Test
Trial Overview The trial is evaluating the Metrix COVID/Flu Test's accuracy for detecting SARS-CoV-2, Flu A, and Flu B from swab or saliva samples. The testing environment mimics home use but takes place near active clinical sites across multiple U.S. locations and potentially abroad.
How Is the Trial Designed?
1Treatment groups
Experimental Treatment
Group I: OTC StudyExperimental Treatment1 Intervention
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.

Find a Clinic Near You

Who Is Running the Clinical Trial?

Aptitude Medical Systems

Lead Sponsor

Trials
2
Recruited
2,000+

Biomedical Advanced Research and Development Authority

Collaborator

Trials
108
Recruited
574,000+

Published Research Related to This Trial

The study of 4815 patients at a Triage and Test Center found that a low-threshold testing process for COVID-19 was safe, with a 30-day mortality rate of only 0.04% and a COVID-19-related re-presentation rate of 1.4%.
Clinical symptoms such as fever, myalgia, and cough were significant predictors of a positive SARS-CoV-2 test result, indicating that relying solely on clinical parameters for diagnosis is not sufficient.
COVID-19 Triage and Test Center: Safety, Feasibility, and Outcomes of Low-Threshold Testing.Mansella, G., Rueegg, M., Widmer, AF., et al.[2020]
A new four-in-one specimen pooling algorithm for SARS-CoV-2 testing was developed and validated, showing a high agreement of 96.8% with individual testing results, which is crucial during high demand periods like the COVID-19 pandemic.
The implementation of this pooling method resulted in an impressive 85.5% reduction in consumable costs over 8 months, effectively increasing testing capacity and resource efficiency without compromising the accuracy of results.
Increasing SARS-CoV-2 testing capacity through specimen pooling: An acute care center experience.Cabrera, A., Al Mutawah, F., Kadour, M., et al.[2023]
In a study of 947 patients tested for COVID-19 in an otolaryngology clinic, the point-of-care nucleic acid amplification test showed a low true positive rate of only 0.95%, indicating that most positive cases were clinically suspected rather than detected through routine screening.
The study found that symptomatic patients and those seen by advanced practice practitioners had significantly higher true positivity rates, suggesting that targeted testing in these groups may be more effective.
Utility of Point-of-Care COVID-19 Testing in an Outpatient Otolaryngology clinic.Ganesh, M., Brawley, CC., Khanwalkar, A., et al.[2022]

Citations

COVID-19 Triage and Test Center: Safety, Feasibility, and Outcomes of Low-Threshold Testing. [2020]
Increasing SARS-CoV-2 testing capacity through specimen pooling: An acute care center experience. [2023]
Utility of Point-of-Care COVID-19 Testing in an Outpatient Otolaryngology clinic. [2022]
The impact of point-of-care testing for influenza A and B on patient flow and management in a medical assessment unit of a general hospital. [2020]
Real-world evaluation of the Lucira Check-It COVID-19 loop-mediated amplification (LAMP) test. [2023]
Horses for courses? Assessing the potential value of a surrogate, point-of-care test for SARS-CoV-2 epidemic control. [2022]
Portable RT-PCR System: a Rapid and Scalable Diagnostic Tool for COVID-19 Testing. [2021]
VALCOR: a protocol for the validation of SARS-corona virus-2 assays. [2022]
The Hologic Aptima SARS-CoV-2 assay enables high ratio pooling saving reagents and improving turnaround time. [2021]
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