SARS Coronavirus 2 RT-PCR Testing
Conditions
Keywords
Nasopharyngeal Swab, COVID-19 Screening
Brief summary
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.
Detailed description
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.
Interventions
None listed
Sponsors
VA Office of Research and Development
Study design
Observational model
OTHER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Symptomatic or COVID-19 positive (within the past 2 weeks) * Has a COVID-19 positive household member * Female and male Veterans or female and male VHA employees * Able and willing to give informed consent
Exclusion criteria
* Self-reported history of frequent nosebleeds or a diagnosis of coagulopathy or any bleeding disorders * Unsuitability for mid-turbinate or nasopharyngeal swabbing due to prior surgery * Need for legally authorized representative for purpose of giving consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Sensitivity | Day 1 | Ability for the alternative swab to correctly predict a positive test result from the standard of care swab (1st swab) |
| Specificity | Day 1 | Ability for the alternative swab to correctly predict a negative test result from the standard of care swab (1st swab) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Epistaxis rate | Day 1 | Rate of nosebleed, described as any detectable presence of blood on either swab |
| Sensitivity | Day 1 | 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. |
| Specificity | Day 1 | 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. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORJoseph Iaquinto, PhD
VA Puget Sound Health Care System Seattle Division, Seattle, WA
Outcome results
None listed