Spartan COVID-19 System: Evaluation of Clinical Sample Collection

Study Overview
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Brief Summary
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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
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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.

Official Title
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Evaluation of Clinical Sample Collection Project: Spartan COVID-19

Conditions
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Covid19

Intervention / Treatment
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* Device: Spartan COVID-19 System


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: must have tested positive for COVID-19 via the existing nucleic acid testing method. Exclusion Criteria: -

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Interventional Model Description: Each Patient enrolle dint he study will experience the same modes of sample collection and sample analysis.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Method 1- Nasopharyngeal Swab in transfer liquid<br>A nasopharyngeal swab will inoculate a proprietary solution which will be transferred to the Spartan COVID-19 System for analysis | Device: Spartan COVID-19 System<br>* PCR analysis of patient samples using the Spartan COVID-19 System<br>|
| Experimental: Method 2- Dipping of specialized swab in VTM<br>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. | Device: Spartan COVID-19 System<br>* PCR analysis of patient samples using the Spartan COVID-19 System<br>|
| Experimental: Method 3: Direct input of VTM<br>Using the VTM from Method 2, pipette 10uL of VTM, inoculated with sample, into the Spartan COVID-19 System for analysis. | Device: Spartan COVID-19 System<br>* PCR analysis of patient samples using the Spartan COVID-19 System<br>|
| Experimental: Method 4: Collection of nasal sample.<br>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. | Device: Spartan COVID-19 System<br>* PCR analysis of patient samples using the Spartan COVID-19 System<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Asses the % agreement between predicate results and Spartan COVID-19 results. | 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. | Through study completion; anticipated to be less than 6 months. |