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| Name | Class |
|---|---|
| Humber River Hospital | OTHER |
| The Ottawa Hospital | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Method 1- Nasopharyngeal Swab in transfer liquid | Experimental | A nasopharyngeal swab will inoculate a proprietary solution which will be transferred to the Spartan COVID-19 System for analysis |
|
| Method 2- Dipping of specialized swab in VTM | Experimental | 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. |
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| Method 3: Direct input of VTM | Experimental | Using the VTM from Method 2, pipette 10uL of VTM, inoculated with sample, into the Spartan COVID-19 System for analysis. |
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| Method 4: Collection of nasal sample. | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Spartan COVID-19 System | Device | PCR analysis of patient samples using the Spartan COVID-19 System |
|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
-
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| Name | Affiliation | Role |
|---|---|---|
| Tara Linseman, MSc | Spartan Bioscience Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Humber River Hospital | North York | Ontario | M3M 0B2 | Canada | ||
| The Univeristy of Ottawa Heart Institute |
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| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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Each Patient enrolle dint he study will experience the same modes of sample collection and sample analysis.
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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.
| Ottawa |
| Ontario |
| K1Y4W7 |
| Canada |
| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |