Evaluation of Clinical Sample Collection Project: Spartan COVID-19
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 27
- Locations
- 2
- Primary Endpoint
- Asses the % agreement between predicate results and Spartan COVID-19 results.
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Diagnostic
- Masking
- Single (Participant)
Masking Description
The results of the Spartan COVID-19 System tests will not be shared with the participant or the lab, but the lab results will be shared with Spartan once analysis of the Spartan System samples is complete.
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •must have tested positive for COVID-19 via the existing nucleic acid testing method.
Exclusion Criteria
- Not provided
Arms & Interventions
Method 4: Collection of nasal sample.
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.
Intervention: Spartan COVID-19 System (Device)
Method 1- Nasopharyngeal Swab in transfer liquid
A nasopharyngeal swab will inoculate a proprietary solution which will be transferred to the Spartan COVID-19 System for analysis
Intervention: Spartan COVID-19 System (Device)
Method 2- Dipping of specialized swab in VTM
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.
Intervention: Spartan COVID-19 System (Device)
Method 3: Direct input of VTM
Using the VTM from Method 2, pipette 10uL of VTM, inoculated with sample, into the Spartan COVID-19 System for analysis.
Intervention: Spartan COVID-19 System (Device)
Outcomes
Primary Outcomes
Asses the % agreement between predicate results and Spartan COVID-19 results.
Time Frame: 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.
Secondary Outcomes
No secondary outcomes reported