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

Overview

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.

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Non-Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Other
    • Masking: None (Open Label)
  • Study Primary Completion Date: July 31, 2020

Interventions

  • Device: Control swab
    • FDA-cleared nasopharyngeal swab
  • Device: Prototype swab
    • Injection molded polypropylene flocked nylon nasopharyngeal swab

Arms, Groups and Cohorts

  • Active Comparator: Control swab
    • FDA cleared swab
  • Experimental: Prototype swab
    • Injection molded polypropylene flocked nylon NP swab

Clinical Trial Outcome Measures

Primary Measures

  • 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.

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: N/A

Maximum Age: 99 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • University of Virginia
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Amy Mathers, MD, Principal Investigator, University of Virginia
  • Overall Contact(s)
    • Limor Steinberg, 434-243-9873, LIS5AY@virginia.edu

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