Nasal Swab Objective and Statistical Evaluation (NOSE Study)

VA Office of Research and Development1,179 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

1,179

Conditions

SARS Coronavirus 2 RT-PCR Testing

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

VA Puget Sound Health Care System Seattle Division, Seattle, WA

Seattle, Washington, United States

Outcomes

Primary Outcomes

Sensitivity

Ability for the alternative swab to correctly predict a positive test result from the standard of care swab (1st swab)

Time frame: Day 1

Specificity

Ability for the alternative swab to correctly predict a negative test result from the standard of care swab (1st swab)

Time frame: Day 1

Secondary Outcomes

Epistaxis rate

Rate of nosebleed, described as any detectable presence of blood on either swab

Time frame: 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.

Time frame: 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.

Time frame: Day 1

Data from ClinicalTrials.gov

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