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

Trial Summary

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.

How does the Metrix COVID-19 Test differ from other COVID-19 tests?

The Metrix COVID-19 Test is unique because it is a point-of-care test, meaning it can be used directly at the location where the patient is, providing rapid results without the need for a full laboratory setup. This makes it particularly useful in remote or low-resourced settings where traditional lab-based tests are not feasible. ^{1 2 3 4 5}

What is the purpose of this trial?

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 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 Test for the detection of SARS-CoV-2 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 the detection of SARS-CoV-2.

Eligibility Criteria

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

I understand the study and agree to participate.

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 am at least 2 years old.

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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 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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Portable RT-PCR System: a Rapid and Scalable Diagnostic Tool for COVID-19 Testing. [2021]

2. England pubmed.ncbi.nlm.nih.gov

VALCOR: a protocol for the validation of SARS-corona virus-2 assays. [2022]

3. United States 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. [2021]

4. Netherlands 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. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

EUAdb: A resource for COVID-19 test development and comparison. [2022]