Metrix COVID Test for COVID-19

Recruiting at 2 trial locations

Overseen By Brad Killingsworth, M.A.

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: Aptitude Medical Systems

Must not be taking: Antivirals, Covid treatments

Disqualifiers: Craniofacial injury, English illiteracy, 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

1000 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new COVID-19 home test, the Metrix COVID Test, to evaluate its effectiveness in identifying the virus from nose swabs taken at home. The goal is to ensure it provides accurate results compared to an established FDA-approved test. Individuals with symptoms such as fever, cough, or loss of taste and smell may be suitable for this trial. Participants will collect their own nose swabs, which will then be compared to samples taken by healthcare professionals. As an unphased trial, this study allows participants to contribute to the development of accessible testing solutions.

Do I need to stop my current medications to join the trial?

If you are currently taking antiviral medications or treatments for COVID-19, you cannot participate in the trial. Otherwise, the protocol does not specify if you need to stop other medications.

What prior data suggests that the Metrix COVID Test is safe for use in home testing environments?

Research shows that the Metrix COVID-19 Test is safe for home use. Individuals aged 14 and older can use it independently, while children as young as 2 can use it with adult assistance. This test detects the SARS-CoV-2 virus using samples from either a nose swab or saliva.

The test has been validated for use outside of laboratories, such as at home or in urgent care centers. No major issues have been reported from using this test. However, users should be aware that, like any test, it might occasionally produce a false positive, indicating the presence of the virus when it is not there.

Overall, research supports the safety and effectiveness of the Metrix COVID-19 Test for its intended use. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The Metrix COVID-19 Test stands out because it simplifies the testing process by allowing individuals to collect their own samples at home, potentially increasing accessibility and convenience compared to standard tests that require healthcare professionals to administer. This test uses advanced technology to deliver quick and reliable results, easing the burden on medical facilities and offering faster peace of mind for users. Researchers are excited about this test because it could make COVID-19 testing more accessible to the public, especially for symptomatic individuals who need quick answers.

What evidence suggests that the Metrix COVID Test is effective for detecting COVID-19?

Research has shown that the Metrix COVID-19 Test, studied in this trial, delivers lab-quality results in under 30 minutes. This rapid detection can identify the virus early, even before symptoms appear, enabling timely treatment and reducing infection spread. The test is simple and efficient, suitable for use outside traditional lab settings, such as at home. Importantly, it aims to reduce false positives, making it less likely to incorrectly indicate COVID-19 when it is not present. This reliability makes the test a dependable choice for detecting COVID-19 in various environments. ^{2 3 6 7 8}

Are You a Good Fit for This Trial?

This trial is for individuals who are in environments that simulate a home setting, likely near urgent care facilities. The main requirement is to provide samples for the new Metrix COVID Test designed for at-home use. Specific eligibility criteria aren't provided, but participants would typically be those suspected of having COVID-19 or requiring testing.

Inclusion Criteria

Participant or guardian agrees to read, and is able to read with understanding, the AN swab QRI prior to beginning the operation of each of the Metrix COVID-19 Test

I understand the study and agree to participate.

I am willing and able to provide samples and sign the consent form for the study.

Exclusion Criteria

I am currently taking or have recently taken medication for COVID-19.

I cannot read or understand English.

Participant or guardian is not able to comply with nasal swab collection requirements following the QRI

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Testing

Participants self-collect AN swab samples for the Metrix COVID Test in simulated home environments. Comparator samples are collected by healthcare practitioners.

1 day

1 visit (in-person)

Analysis

Test results from the Metrix COVID Test are compared to results from the FDA-cleared comparator assay.

1-2 weeks

Follow-up

Participants are monitored for safety and effectiveness after testing.

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Aptitude Medical Systems Metrix COVID-19 Test

Trial Overview The study tests the Aptitude Medical Systems Metrix COVID Test's accuracy and reliability in detecting SARS-CoV-2 from AN swab samples in non-laboratory settings. It compares results with an FDA-cleared assay to validate its performance.

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.

Aptitude Medical Systems Metrix COVID-19 Test is already approved in United States for the following indications:

Approved in United States as Metrix COVID-19 Test for:

• Qualitative detection of nucleic acid from SARS-CoV-2 in anterior nasal (nares) swab and saliva specimens

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]

In a study of 183 respiratory specimens from suspected COVID-19 patients, the cobas SARS-CoV-2 test demonstrated the highest positive percent agreement (100%) for detecting SARS-CoV-2 RNA, indicating its strong efficacy in identifying positive cases.

While all tests performed adequately, the cobas test showed significantly higher sensitivity compared to the other assays, suggesting it may be the most reliable option for clinical laboratories during the pandemic.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of Two Commercial Platforms and a Laboratory-Developed Test for Detection of Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) RNA. Mannonen, L., Kallio-Kokko, H., Loginov, R., et al.[2021]

The Abbott and Roche point-of-care tests (POCTs) for SARS-CoV-2 showed high specificity (98.7% and 100%) and sensitivity (97.2%) when used on samples from individuals at least 14 days post-positive RT-PCR, indicating they are reliable for detecting antibodies in recovered patients.

Both POCTs demonstrated excellent concordance with chemiluminescent immunoassays (CLIAs), with a 97.2% agreement for Abbott and 100% for Roche, suggesting that these tests can effectively substitute CLIAs in appropriate cases, particularly in low prevalence areas when combined with antigen testing.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Performance of two rapid point of care SARS-COV-2 antibody assays against laboratory-based automated chemiluminescent immunoassays for SARS-COV-2 IG-G, IG-M and total antibodies. Lau, CS., Hoo, SP., Liang, YL., et al.[2022]

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]

A relational database has been developed to provide standardized information on COVID-19 diagnostic tests that have received Emergency Use Authorizations (EUAs) from the FDA, which can help improve testing efficiency and effectiveness.

The database reveals significant variations among tests in terms of sensitivity, sample types, and other critical factors, highlighting the need for accessible information to guide the selection of appropriate diagnostic tools and prevent delays in testing during future outbreaks.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

EUAdb: A resource for COVID-19 test development and comparison. Woronik, A., Shaffer, HW., Kiontke, K., et al.[2022]

Citations

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

Metrix® COVID-19 Test Metrix delivers lab-quality results in under 30 minutes, so that you can catch infection before symptoms start, seek timely treatment, and stop the spread.

2. fda.gov fda.gov/media/162403/download

Metrix® COVID-19 Test This Aptitude secure web portal will report all test results received from individuals who use the authorized product to relevant public health authorities in.

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

Clinical Validation of the Aptitude Medical Systems Metrix ... The Metrix COVID Test will be evaluated for use in Point-of-Care and Non-Laboratory settings in a home testing environment utilizing the clinical study ...

4. fda.gov fda.gov/media/162402/download

Fact Sheet for Healthcare Providers The Metrix COVID-19 Test has been designed to minimize the likelihood of false positive test results.

5. sekisuidiagnostics.com sekisuidiagnostics.com/product/metrix-poct-covid-19-test/

The Metrix® COVID-19 Test The Metrix® COVID-19 Test is a testing solution designed for simplicity and efficiency. This lab-quality COVID – 19 test delivers results in 30 minutes.

6. fda.gov fda.gov/media/162401/download

Metrix COVID-19 Test The Metrix COVID-19 test is for non-prescription home use to detect SARS-CoV-2 in nasal swabs and saliva, for ages 14+ (self-collected) or 2+ ( ...

7. accessdata.fda.gov accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=20102866&pc=QJR

APTITUDE MEDICAL SYSTEMS METRIX COVID-19 TEST The ifu for the metrix covid-19 test informs the user in the case of a false positive result: "positive results indicate the presence of viral rna, but clinical ...

8. sekisuidiagnostics.com sekisuidiagnostics.com/wp-content/uploads/2024/01/EUA-Aptitude-2.pdf

Metrix™ COVID-19 Test The Metrix COVID-19 Test is a single-use molecular test for detecting SARS-CoV-2 RNA in saliva or nasal swabs, using a NAAT similar to PCR.