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

NCT04628208 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 81

Last updated 2021-08-30

No results posted yet for this study

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.

Conditions

  • Covid19

Interventions

DIAGNOSTIC_TEST

Spartan COVID-19 v2 System

A nasopharyngeal swab sample analyzed on the Spartan COVID-19 v2 System for the detection of SARS-CoV-2.

Sponsors & Collaborators

  • Spartan Bioscience Inc.

    lead INDUSTRY

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-11-17
Primary Completion
2020-12-07
Completion
2020-12-07

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04628208 on ClinicalTrials.gov