Clinical Study Spartan COVID-19 V2 System (Canada Alternate)

Study Overview
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Brief Summary
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This multicentre prospective study will enroll a sufficient number of patients to afford approximately 30 positives and > 30 negatives (as determined by the SOC - Comparator method) in the United States and/or Canada. One to three sites in the Canada will participate over an approximate 6-week enrolment period. The actual enrolment period will be dependent upon prevalence of Covid-19, and site set up. Once positives sample size is achieved, expected SARC-CoV-2 negative subjects will be permitted. Once subjects are consented and recruited for the study, up to three (3) study-specific nasopharyngeal samples for each patient will be collected by trained operators at the clinical site: a single SOC swab, and two (2) Spartan swabs where the second swab is optional and used when the first Spartan swab test does not produce a positive or negative result (inconclusive). The first swab sample will be tested at the clinical site according to standard of care protocols currently in place for the sites' nasopharyngeal swab-based SARS-CoV-2 RT-PCR testing. The second nasopharyngeal sample will be tested at the site using the Spartan COVID-19 v2 System. A third, optional nasopharyngeal sample, if collected, will be tested using the Spartan COVID-19 v2 System only when the test conducted with the second nasopharyngeal swab does not produce a positive or negative result.

Official Title
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Assess the Performance of Spartan COVID-19 V2 System in a Clinical Setting in Comparison to a Laboratory (Standard of Care (SOC)) PCR Method (Canada Alternate)

Conditions
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Covid19

Intervention / Treatment
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* Diagnostic Test: Spartan COVID-19 v2 System


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Suspected SARS-CoV-2 infection by a healthcare provider, and whose first symptoms presented ≤ 7 days of onset; or Suspected SARS-CoV-2 infection from the same household of a person who tested positive for SARS-CoV-2 using an authorized test; or Known positive SARS-CoV-2 infection using an authorized test, and whose first symptoms presented ≤ 7 days of onset; or Expected negative SARS-CoV-2 infection - individuals with no symptoms or a recent negative result by an authorized test. Exclusion Criteria: Vulnerable populations (e.g., women with pregnancy, institutionalized individual) as deemed inappropriate for study by the site investigator Individuals with self-reported nosebleed within 24 hours of presentation

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Negative for COVID-19<br>Subject determined to be negative for COVID-19 by the standard of care nasopharyngeal swab-based SARS-CoV-2 RT-PCR test. | Diagnostic Test: Spartan COVID-19 v2 System<br>* A nasopharyngeal swab sample analyzed on the Spartan COVID-19 v2 System for the detection of SARS-CoV-2.<br>|
| Positive for COVID-19<br>Subject determined to be positive for COVID-19 by the standard of care nasopharyngeal swab-based SARS-CoV-2 RT-PCR test. | Diagnostic Test: Spartan COVID-19 v2 System<br>* A nasopharyngeal swab sample analyzed on the Spartan COVID-19 v2 System for the detection of SARS-CoV-2.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent Agreement between SOC test and Spartan COVID-19 test | Overall percent agreement between the test results generated by the Spartan COVID-19 v2 System and the nasopharyngeal swab-based SARS-Cov-2 test currently in use at the clinical site (SOC test) | 24 hours |