Metrix Test for COVID-19 and Flu

No longer recruiting at 2 trial locations

Overseen By Tyler Chozinski, PhD

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: Aptitude Medical Systems

Must not be taking: Antivirals, Covid treatments

Disqualifiers: Recent vaccine, Nasal surgery, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new home test for COVID-19 and the flu. It aims to evaluate how effectively the Metrix COVID/Flu Test (also known as the Aptitude Medical Systems Metrix COVID/Flu Test) detects these viruses in a home-like setting, using samples such as nasal swabs or saliva. The study seeks participants who currently have symptoms like fever, cough, or a sore throat. Participants should avoid eating or drinking for 30 minutes before providing a saliva sample. Those who have received a COVID-19 or flu vaccine in the last five days or are on certain antiviral treatments may not qualify for this trial. As an unphased trial, this study offers a unique opportunity to contribute to the development of accessible home testing solutions.

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.

What prior data suggests that the Metrix COVID/Flu Test is safe for home use?

Research has shown that the Metrix COVID/Flu Test is approved for home use. The FDA has evaluated it for safety and effectiveness in detecting COVID-19 and flu viruses in individuals aged 14 and older. The test is user-friendly, requiring only a simple nose swab or saliva sample, and no serious safety issues have been reported. Designed for home use, it ensures ease and safety for self-administration. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The Metrix Test for COVID-19 and Flu is unique because it allows for at-home, self-collected testing, which is a significant shift from the current standard options that typically require professional healthcare settings for sample collection. Researchers are excited about this test because it provides a convenient and accessible way for individuals to get tested for both COVID-19 and the flu simultaneously, potentially leading to quicker diagnosis and treatment. This ease of use is particularly beneficial during flu season, when rapid and accurate differentiation between COVID-19 and the flu is crucial for effective treatment and containment.

What evidence suggests that the Metrix COVID/Flu Test is effective for detecting SARS-CoV-2, Influenza A, and Influenza B?

Research shows that the Metrix COVID/Flu Test, used by participants in this trial, reliably detects COVID-19 and the flu (both Influenza A and B). It accurately distinguishes between these viruses, aiding in the selection of appropriate treatment. The test is easy to use at home and provides results comparable to those from a lab, often in 30 minutes or less. This convenience allows individuals to determine infection status without visiting a doctor’s office. The test's accuracy in identifying the virus matches that of other FDA-approved tests, supporting its effectiveness in managing respiratory infections efficiently. ^{2 3 4 5 6}

Who Is on the Research Team?

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.

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.

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?

Group I: OTC Study Experimental Treatment 1 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.

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 portable Biomeme SARS-CoV-2 system demonstrated a high agreement rate of 98.4% with standard RT-PCR tests across 192 samples, indicating its accuracy for COVID-19 testing.

This system provides rapid results for nine samples in just 80 minutes, making it suitable for point-of-care testing in remote or low-resourced environments, thus helping to decentralize COVID-19 testing efforts.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Portable RT-PCR System: a Rapid and Scalable Diagnostic Tool for COVID-19 Testing. Zowawi, HM., Alenazi, TH., AlOmaim, WS., et al.[2021]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Increasing SARS-CoV-2 testing capacity through specimen pooling: An acute care center experience. Cabrera, A., Al Mutawah, F., Kadour, M., et al.[2023]

The Lucira Check-It COVID-19 Test demonstrated comparable performance to traditional laboratory nucleic acid amplification tests (NAATs), making it a reliable option for rapid testing in various settings, including emergency departments and pre-operative areas.

This point-of-care test is easy to use, requiring minimal training for healthcare workers, and can significantly reduce delays in test results, thereby improving patient flow and minimizing staffing shortages during the COVID-19 pandemic.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Real-world evaluation of the Lucira Check-It COVID-19 loop-mediated amplification (LAMP) test. Simms, E., McCracken, GR., Hatchette, TF., et al.[2023]

The Hologic Aptima™ TMA SARS-CoV-2 assay shows strong performance in pooled testing, achieving a positive percent agreement (PPA) of 95.2% for pools with strong-positive samples, indicating its efficacy as a screening tool for SARS-CoV-2.

However, the assay's effectiveness decreases for pools containing weak-positive samples, with a PPA of only 40%, highlighting the need to monitor and adjust pooling strategies to minimize false negatives, especially when weak positives are present.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Hologic Aptima SARS-CoV-2 assay enables high ratio pooling saving reagents and improving turnaround time. Newsom, K., Zhang, Y., Chamala, S., et al.[2021]

The Abbott ID NOW point-of-care testing (POCT) for Influenza A&B demonstrated high sensitivity (92%) and perfect specificity (100%) when compared to the laboratory-based GeneXpert Flu+RSV kit, indicating it is a reliable diagnostic tool.

Implementation of the POCT significantly reduced antibiotic prescriptions by 33% and decreased the average hospital stay from 5.26 days to 3.73 days, highlighting its effectiveness in improving patient management and resource utilization during influenza outbreaks.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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. O'Connell, S., Conlan, C., Reidy, M., et al.[2020]

The VALCOR protocol aims to establish a standardized framework for validating SARS-CoV-2 diagnostic assays, addressing the urgent need for reliable testing during the COVID-19 pandemic.

By using a combination of clinical specimens from COVID-19 patients and healthy carriers, along with standardized artificial specimens, VALCOR seeks to ensure that assays meet common criteria to minimize false results and improve diagnostic accuracy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

VALCOR: a protocol for the validation of SARS-corona virus-2 assays. Arbyn, M., Dhillon, SK., Martinelli, M., et al.[2022]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Utility of Point-of-Care COVID-19 Testing in an Outpatient Otolaryngology clinic. Ganesh, M., Brawley, CC., Khanwalkar, A., et al.[2022]

FebriDx, a point-of-care test (POCT), shows potential for distinguishing between viral and bacterial infections in patients with influenza-like illnesses, but its effectiveness is limited when COVID-19 case numbers are low or when other respiratory viruses are prevalent.

Current data on FebriDx's performance in primary care settings is insufficient, and reliable SARS-CoV-2-specific tests are expected to become the preferred option due to their higher specificity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Horses for courses? Assessing the potential value of a surrogate, point-of-care test for SARS-CoV-2 epidemic control. Ismail, SA., Huntley, C., Post, N., et al.[2022]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

COVID-19 Triage and Test Center: Safety, Feasibility, and Outcomes of Low-Threshold Testing. Mansella, G., Rueegg, M., Widmer, AF., et al.[2020]

Citations

1. shop.aptitudemedical.com shop.aptitudemedical.com/products/metrix%C2%AE-covid-flu-test

Metrix® COVID/Flu Test Metrix COVID/Flu test is a lab-quality molecular test for the simultaneous detection and differentiation of SARS-CoV-2, influenza A, and influenza B nucleic ...

2. fda.gov fda.gov/media/185662/download?attachment

Metrix COVID/Flu Test - Healthcare Provider Fact Sheet The Metrix COVID/Flu Test can be used for the detection and differentiation of SARS-CoV-2, influenza A, and/or influenza B in individuals aged.

3. clinicaltrials.gov clinicaltrials.gov/study/NCT06744660

Clinical Validation of the Aptitude Medical Systems Metrix ... Primary objective of this study is to evaluate the performance (positive percent agreement, negative percent agreement and 95% confidence intervals for upper ...

4. shop.aptitudemedical.com shop.aptitudemedical.com/products/metrix-covid-19-test

Metrix® COVID-19 Test The Metrix® COVID-19 Test delivers simple, efficient, lab-quality testing to your door, with results in 30 minutes or less. Designed for use with the Metrix ...

5. cardinalhealth.com cardinalhealth.com/content/dam/corp/web/documents/ifu/cardinal-health-metrix-covid-19-flu-test-qri.pdf

Aptitude Metrix COVID/Flu Test Quick Reference Instructions Positive test results do not rule out bacterial infection or co-infection with other viruses. Individuals who test positive with the Metrix COVID/Flu Test ...

6. fda.gov fda.gov/media/185664/download?attachment

Metrix COVID/Flu Test Letter of Authorization This test is authorized for non-prescription home use with anterior nasal (AN) swab specimens from individuals aged 14 years or older (self- ...