Metrix COVID Test for COVID-19
Recruiting in Palo Alto (17 mi)
+2 other locations
Age: Any Age
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Aptitude Medical Systems
Must not be taking: Antivirals, Covid treatments
Disqualifiers: Craniofacial injury, English illiteracy, others
No Placebo Group
Approved in 1 Jurisdiction
Trial Summary
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.
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.
12345Eligibility 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.
+2 more
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
+6 more
Trial 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
Participant Groups
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.
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.
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
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
AFC MontclairBirmingham, AL
PPU Mid CityBaton Rouge, LA
AFC MadisonMadison, AL
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Who Is Running the Clinical Trial?
Aptitude Medical SystemsLead Sponsor
Biomedical Advanced Research and Development AuthorityCollaborator
References
Portable RT-PCR System: a Rapid and Scalable Diagnostic Tool for COVID-19 Testing. [2021]Combating the ongoing coronavirus disease 2019 (COVID-19) pandemic demands accurate, rapid, and point-of-care testing with fast results to triage cases for isolation and treatment. The current testing relies on reverse transcriptase PCR (RT-PCR), which is routinely performed in well-equipped laboratories by trained professionals at specific locations. However, during busy periods, high numbers of samples queued for testing can delay the test results, impacting efforts to reduce the infection risk. Besides, the absence of well-established laboratories at remote sites and low-resourced environments can contribute to a silent spread of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). These reasons compel the need to accommodate point-of-care testing for COVID-19 that meets the ASSURED criteria (affordable, sensitive, specific, user-friendly, rapid and robust, equipment-free, and deliverable). This study assessed the agreement and accuracy of the portable Biomeme SARS-CoV-2 system against the gold standard tests. Nasopharyngeal and nasal swabs were used. Of the 192 samples tested using the Biomeme SARS-CoV-2 system, the results from 189 samples (98.4%) were in agreement with the reference standard-of-care RT-PCR testing for SARS-CoV-2. The portable system generated simultaneous results for nine samples in 80 min with high positive and negative percent agreements of 99.0% and 97.8%, respectively. We performed separate testing in a sealed glove box, offering complete biosafety containment. Thus, the Biomeme SARS-CoV-2 system can help decentralize COVID-19 testing and offer rapid test results for patients in remote and low-resourced settings.
VALCOR: a protocol for the validation of SARS-corona virus-2 assays. [2022]Testing for SARS-CoV-2, together with vaccination, is one of the most vital strategies in curbing the current COVID-19 pandemic. The pandemic has led to an unprecedented need for diagnostic testing and the rapid emergence of an abundance of commercial assays on the market. Due to the nature of the pandemic and in the interest of health protection, many of these assays received provisional authorisation for emergency use without thorough validation. To limit false negative and false positive results, it is key to define common criteria that SARS-CoV-2 assays need to fulfil. VALCOR or "VALidation of SARS-CORona Virus-2 assays" is a protocol designed to set up a framework for test validation of SARS-CoV-2 virus assays.
Comparison of Two Commercial Platforms and a Laboratory-Developed Test for Detection of Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) RNA. [2021]Mitigation of the ongoing coronavirus disease 2019 (COVID-19) pandemic requires reliable and accessible laboratory diagnostic services. In this study, the performance of one laboratory-developed test (LDT) and two commercial tests, cobas SARS-CoV-2 (Roche) and Amplidiag COVID-19 (Mobidiag), were evaluated for the detection of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) RNA in respiratory specimens. A total of 183 specimens collected from suspected COVID-19 patients were studied with all three methods to compare their performance. In relation to the reference standard, which was established as the result obtained by two of the three studied methods, the positive percent agreement was highest for the cobas test (100%), followed by the Amplidiag test and the LDT (98.9%). The negative percent agreement was lowest for the cobas test (89.4%), followed by the Amplidiag test (98.8%), and the highest value was obtained for the LDT (100%). The dilution series of positive specimens, however, suggests significantly higher sensitivity for the cobas assay in comparison with the other two assays, and the low negative percent agreement value may be due to the same reason. In general, all tested assays performed adequately. Clinical laboratories need to be prepared for uninterrupted high-throughput testing during the coming months to mitigate the pandemic. To ensure no interruption, it is critical that clinical laboratories maintain several simultaneous platforms in their SARS-CoV-2 nucleic acid testing.
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]We evaluated two SARS-CoV-2 antibody point-of-care tests (POCTs) (Abbott Panbio COVID-19 IgG/IgM and Roche SARS-CoV-2 Rapid Antibody tests) and compared the results to their respective chemiluminescent immunoassays (CLIAs) (Abbott Architect IgM, Architect IgG, Roche Cobas total antibody assays).
EUAdb: A resource for COVID-19 test development and comparison. [2022]Due to the sheer number of COVID-19 (coronavirus disease 2019) cases there is a need for increased world-wide SARS-CoV-2 testing capability that is both efficient and effective. Having open and easy access to detailed information about these tests, their sensitivity, the types of samples they use, etc. would be highly useful to ensure their reproducibility, to help clients compare and decide which tests would be best suited for their applications, and to avoid costs of reinventing similar or identical tests. Additionally, this resource would provide a means of comparing the many innovative diagnostic tools that are currently being developed in order to provide a foundation of technologies and methods for the rapid development and deployment of tests for future emerging diseases. Such a resource might thus help to avert the delays in testing and screening that was observed in the early stages of the pandemic and plausibly led to more COVID-19-related deaths than necessary. We aim to address these needs via a relational database containing standardized ontology and curated data about COVID-19 diagnostic tests that have been granted Emergency Use Authorizations (EUAs) by the FDA (US Food and Drug Administration). Simple queries of this actively growing database demonstrate considerable variation among these tests with respect to sensitivity (limits of detection, LoD), controls and targets used, criteria used for calling results, sample types, reagents and instruments, and quality and amount of information provided.