Spartan COVID-19 System: Evaluation of Clinical Sample Collection

Spartan Bioscience

Status: Completed

Conditions: Covid19

Treatments: Device: Spartan COVID-19 System

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04473248

VNV-00552

Details and patient eligibility

About

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.

Full 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.

Enrollment: 27 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: Single Blind

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27 participants in 4 patient groups

Method 1- Nasopharyngeal Swab in transfer liquid

Experimental group

Description:

A nasopharyngeal swab will inoculate a proprietary solution which will be transferred to the Spartan COVID-19 System for analysis

Treatment:

Device: Spartan COVID-19 System

Method 2- Dipping of specialized swab in VTM

Experimental group

Description:

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.

Treatment:

Device: Spartan COVID-19 System

Method 3: Direct input of VTM

Experimental group

Description:

Using the VTM from Method 2, pipette 10uL of VTM, inoculated with sample, into the Spartan COVID-19 System for analysis.

Treatment:

Device: Spartan COVID-19 System

Method 4: Collection of nasal sample.

Experimental group

Description:

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.

Treatment:

Device: Spartan COVID-19 System