Spartan COVID-19 System: Evaluation of Clinical Sample Collection

S

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

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

Trial contacts and locations

2

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Data sourced from clinicaltrials.gov

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