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Purpose

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

Eligibility

Eligible Ages
Between 0 Years and 99 Years
Eligible Genders
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.

Study Design

Phase
N/A
Study Type
Interventional
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.
Primary Purpose
Other
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
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

Recruiting Locations

More Details

NCT ID
NCT04368260
Status
Completed
Sponsor
University of Virginia

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.