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Clinical Validation of New Injection Molded Flocked Nasopharyngeal Swabs in Response to the COVID-19 Pandemic

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT04368260
Recruitment Status : Recruiting
First Posted : April 29, 2020
Last Update Posted : April 29, 2020
Information provided by (Responsible Party):
University of Virginia

Brief Summary:

The SARS-CoV-2 pandemic has resulted in an international shortage of the nasopharyngeal (NP) swabs used to collect sample for virological testing. This shortage has become a crisis as testing capacity is growing, and threatens to become the bottleneck at University of Virginia Health System and in the Commonwealth of Virginia, as it already is in other testing centers. To resolve this crisis, a team in the Clinical Microbiology Laboratories at University of Virginia Medical Center has been working closely with biomedical engineers in the University of Virginia (UVA), School of Engineering and with high volume domestic manufacturers developing injection molded polypropylene flocked nylon NP swab.

This prototype will be tested for non-inferiority relative to existing, already validated NP swabs ("control swab") for purposes of molecular microbiology: i.e. the polymerase chain reaction (PCR) tests used for virological testing for SARS-CoV-2. Specifically, the nasopharynx of patients with Covid-19 and patients under investigation (PUI) for Covid-19, the disease caused by SARS-CoV-2, will be swabbed using a prototype swab and a control swab (the standard of care swab), and test for concordance of SARS-CoV-2. In all cases the swab will be transported in validated FDA cleared viral transport medium (VTM) as per standard operating procedure at University of Virginia Medical Center.

Condition or disease Intervention/treatment Phase
COVID19 Device: Control swab Device: Prototype swab Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: The primary objective of this study is to determine whether the newly designed nasopharyngeal swabs perform acceptably compared to standard swabs.
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Clinical Validation of New Injection Molded Flocked Nasopharyngeal Swabs in Response to the COVID-19 Pandemic
Actual Study Start Date : April 24, 2020
Estimated Primary Completion Date : July 31, 2020
Estimated Study Completion Date : July 31, 2020

Arm Intervention/treatment
Active Comparator: Control swab
FDA cleared swab
Device: Control swab
FDA-cleared nasopharyngeal swab

Experimental: Prototype swab
Injection molded polypropylene flocked nylon NP swab
Device: Prototype swab
Injection molded polypropylene flocked nylon nasopharyngeal swab

Primary Outcome Measures :
  1. Number of subjects for which the prototype swab and the control swab provide the same COVID-19 PCR result [ Time Frame: at time of enrollment ]
    Both the prototype and control nasopharyngeal swabs will be utilized in each subject. The rate of agreement between the swabs will be determined by the number of subjects for which both swabs provide the same COVID-19 PCR result.

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 99 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Individuals presenting to the site for clinical care will be evaluated for clinical screening for Covid-19 testing or other respiratory infection testing.
  • Individuals felt identified clinically as needing Covid-19 testing may be approached for study participation.
  • Individuals already under clinical care that have tested positive for Covid-19 will be approached for study participation.
  • Volunteer health care workers who have approached the Principal Investigator

Exclusion Criteria:

  • Known thrombocytopenia of <50,000 platelets/μl (risk of mild bleeding).
  • Individuals presenting with an anatomically altered nasal cavity.
  • Pregnant (self-reported)
  • No other patients will be specifically excluded.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT04368260

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Contact: Limor Steinberg 434-243-9873

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United States, Virginia
University of Virginia Recruiting
Charlottesville, Virginia, United States, 22903
Contact: Limor Steinberg    434-243-9873   
Sponsors and Collaborators
University of Virginia
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Principal Investigator: Amy Mathers, MD University of Virginia
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Responsible Party: University of Virginia Identifier: NCT04368260    
Other Study ID Numbers: HSR200127
First Posted: April 29, 2020    Key Record Dates
Last Update Posted: April 29, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: All individual participant data (IPD) that underlie results in a publication will be shared.
Time Frame: Starting 6 months after publication
Access Criteria: Requests to made to Principal Investigator

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Product Manufactured in and Exported from the U.S.: No