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

Covid19 Clinical Trial

Official title: 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)

Status Completed

Clinical Trial Summary

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.

Clinical Trial Description

n/a

Related Conditions & MeSH terms

• Covid19

• NCT number: NCT04628208
• Study type: Observational
• Source: Spartan Bioscience Inc.
• Status: Completed
• Start date: November 17, 2020
• Completion date: December 7, 2020