Spartan COVID-19 System: Evaluation of Clinical Sample Collection

Not Applicable

Completed

• Conditions: Covid19
• Interventions: Device: Spartan COVID-19 System

• Registration Number: NCT04473248
• Lead Sponsor: Spartan Bioscience Inc.

Brief Summary

This study will evaluate the efficacy of various sample collection methods for use with the Spartan COVID-19 System. It will compare the results from the Spartan COVID-19 System with results that are obtained using a predicate lab-based COVID-19 test that uses a nasopharyngeal swab sample. The goal is to determine which sample collection methods are most effective in capturing SARS-CoV-2 virus.

Detailed Description

Once the subject is recruited,two nasopharyngeal swabs using the standard method will be taken from the patient. Additionally, two nasal swab samples will be taken using the Spartan COVID-19 swabs with an adjusted tip. All samples will be analyzed using the Spartan COVID-19 System.

The lab-based predicate test will be taken at the same time, with results reported back to Spartan to be compared with results obtained from the Spartan COVID-19 System.

Study Timeline

• Study Start: 2020-06-28
• Status Verified: 2020-07
• Study First Submitted: 2020-07-14
• Study First Submitted QC: 2020-07-14
• Study First Posted: 2020-07-16
• Primary Completion: 2020-08-30
• Study Completion: 2020-08-30
• Last Update Submitted: 2020-11-11
• Last Update Posted: 2020-11-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 27

Inclusion Criteria

• must have tested positive for COVID-19 via the existing nucleic acid testing method.

Exclusion Criteria

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Method 2- Dipping of specialized swab in VTM	Spartan COVID-19 System	A nasopharyngeal swab will inoculate VTM solution. A modified traditional Spartan Swab will be dipped into the inoculated VTM solution and then transferred to the Spartan COVID-19 System for analysis.
Method 4: Collection of nasal sample.	Spartan COVID-19 System	Using a modified tip of the Spartan swab, a nasal sample will be taken from the patient and directly placed into the Spartan COVID-19 System for analysis.
Method 3: Direct input of VTM	Spartan COVID-19 System	Using the VTM from Method 2, pipette 10uL of VTM, inoculated with sample, into the Spartan COVID-19 System for analysis.
Method 1- Nasopharyngeal Swab in transfer liquid	Spartan COVID-19 System	A nasopharyngeal swab will inoculate a proprietary solution which will be transferred to the Spartan COVID-19 System for analysis

Primary Outcome Measures

Name	Time	Method
Asses the % agreement between predicate results and Spartan COVID-19 results.	Through study completion; anticipated to be less than 6 months.	The purpose of this study is to evaluate which method has the best % agreement between the lab-based predicate results and Spartan COVID-19 System results.

Trial Locations

Locations (2)

Humber River Hospital; 🇨🇦 North York, Ontario, Canada

The Univeristy of Ottawa Heart Institute; 🇨🇦 Ottawa, Ontario, Canada