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| ID | Type | Description | Link |
|---|---|---|---|
| 1I01RX003767 | U.S. NIH Grant/Contract | View source |
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Supply chain disruptions have led to shortages in test swabs which are used to collect respiratory samples. Lack of these test swabs can reduce a hospital or state's ability to test patients for COVID-19.
To address this shortage, many manufacturers, hospitals and individuals have designed non-traditional 3D printed swabs for COVID-19 diagnosis that could potentially meet demands for nasal swabs. However, questions regarding the safety and effectiveness of these swabs remain.
This study will provide additional, statistically supported evidence as to the safety and efficacy of novel swabs.
This is a prospective, multi-site, non-inferiority study providing a comparison between the performance of traditional, standard of care (SoC) and alternative (ALT) nasal swabs. Nasal swabs and swabbing site of interest for this study is the nasopharynx (NP swab). The primary outcomes of this study are the rate of adverse events and the agreement in laboratory viral detection between SoC and ALT swabs.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard of Care / Standard of Care | Initial cohort to identify the effect of order on swab result. Swab order (standard of care first) was set to preserve clinical test result in case there was an impact to swab order. | ||
| 1st Alt Swab / Standard of Care | Evaluation of 1st alternatively sourced swab to the standard of care swab | ||
| 2nd Alt Swab / Standard of Care | Evaluation of 2nd alternatively sourced swab to the standard of care swab |
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| Measure | Description | Time Frame |
|---|---|---|
| Sensitivity | Ability for the alternative swab to correctly predict a positive test result from the standard of care swab (1st swab) | Day 1 |
| Specificity | Ability for the alternative swab to correctly predict a negative test result from the standard of care swab (1st swab) | Day 1 |
| Measure | Description | Time Frame |
|---|---|---|
| Epistaxis rate | Rate of nosebleed, described as any detectable presence of blood on either swab | Day 1 |
| Sensitivity | Effect of order on the ability of a second swab, a standard of care swab, to correctly predict a positive test result from the first swab, also standard of care swab. |
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Inclusion Criteria:
Exclusion Criteria:
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Employees and patients with recent (<2 weeks) COVID-19 diagnosis for themselves or a member of their home, or who are symptomatic with one or more COVID-19 symptoms are eligible.
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| Name | Affiliation | Role |
|---|---|---|
| Joseph Iaquinto, PhD | VA Puget Sound Health Care System Seattle Division, Seattle, WA | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| VA Puget Sound Health Care System Seattle Division, Seattle, WA | Seattle | Washington | 98108-1532 | United States |
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No samples retained
| Day 1 |
| Specificity | Effect of order on the ability of a second swab, a standard of care swab, to correctly predict a negative test result from the first swab, also standard of care swab. | Day 1 |