About 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 accepts healthy volunteersQualifiers
Participant or guardian understands and is able and willing to provide written informed consent, and assent where applicable, prior to study enrollment.
Male or female aged 2 years or older
Participant is currently exhibiting fever, or one or more symptoms of respiratory tract infection (such as, but not limited to, chills, cough, shortness of breath or difficulty breathing, fatigue, new loss of taste or smell, sore throat, congestion or runny nose, nausea or vomiting or diarrhea). Participant must still be exhibiting symptoms on the day of sample collection.
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.
Disqualifiers
Participant does not understand and/or is not able and willing to sign the study informed consent and/or assent.
Participant or guardian is not able to comply with nasal swab collection requirements following the QRI.
Participant has previously provided a sample for the study.
Participant is not able to tolerate sample collection.
Trial design
Single group
Treatments tested in this trial
Aptitude Medical Systems Metrix COVID Test
Diagnostic testThe Metrix COVID Test is a real-time reverse transcription loop-mediated isothermal amplification reaction (RT-LAMP) test that has been designed to detect viral RNA from SARS-CoV-2 via electrochemical detection using the Metrix Reader. Detection of SARS-CoV-2 gene targets will produce a positive SARS-CoV-2 result. If no target is detected and the internal control amplifies, the result is negative. If no amplification is detected in any of the channels, an invalid result is displayed.
Treatment groups
Trial outcomes
Primary outcomes
Qualitative detection of RNA from SARS-CoV-2 and Measurement of Positive/Negative Percent Agreement with FDA-cleared comparator test
Qualitative detection of RNA from SARS-CoV-2 in unprocessed AN swab samples. Primary objective of this study is to evaluate the performance (positive percent agreement, negative percent agreement and 95% confidence intervals for upper and lower bounds) of the Metrix COVID/Flu Test for the qualitative detection of SARS-CoV-2 viral RNA using AN swab samples. Comparator testing will be performed to determine the status of each sample for comparison to results produced by the candidate test. 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 that detects SARS-CoV-2.
Sponsors and contacts
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Aptitude Medical Systems
Lead sponsor
Biomedical Advanced Research and Development Authority
Collaborator