Supply chain disruptions have led to shortages in test swabs which are used to collectrespiratory samples. Lack of these test swabs can reduce a hospital or state's ability totest patients for COVID-19.To address this shortage, many manufacturers, hospitals and individuals have designednon-traditional 3D printed swabs for COVID-19 diagnosis that could potentially meetdemands for nasal swabs. However, questions regarding the safety and effectiveness ofthese swabs remain.This study will provide additional, statistically supported evidence as to the safety andefficacy 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.
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
VA Puget Sound Health Care System Seattle Division, Seattle, WA
Seattle, Washington, United States
Joseph Iaquinto, PhD, Principal Investigator
VA Puget Sound Health Care System Seattle Division, Seattle, WA