Nasal Swab Objective and Statistical Evaluation (NOSE Study) (Nasal Swab)

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.

Study Overview

• Status: Completed
• Conditions: SARS Coronavirus 2 RT-PCR Testing

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.

• Study Type: Observational
• Enrollment (Actual): 1179

Contacts and Locations

Study Locations

• United States
  • Washington
    • Seattle, Washington, United States, 98108-1532
      • VA Puget Sound Health Care System Seattle Division, Seattle, WA

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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.	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

Collaborators and Investigators

• Sponsor: VA Office of Research and Development
• Investigators: Principal Investigator: Joseph Iaquinto, PhD, VA Puget Sound Health Care System Seattle Division, Seattle, WA

Study record dates

Study Major Dates

• Study Start (Actual): April 5, 2021
• Primary Completion (Actual): August 16, 2022
• Study Completion (Actual): August 16, 2022

Study Registration Dates

• First Submitted: February 25, 2026
• First Submitted That Met QC Criteria: March 10, 2026
• First Posted (Actual): March 13, 2026

Study Record Updates

• Last Update Posted (Actual): March 13, 2026
• Last Update Submitted That Met QC Criteria: March 10, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Nasopharyngeal Swab; COVID-19 Screening
• Other Study ID Numbers: F3767-I; 1I01RX003767 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No