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

NCT04368260 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2022-02-17

Study results available
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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.

Conditions

  • COVID19

Interventions

DEVICE

Control swab

FDA-cleared nasopharyngeal swab

DEVICE

Prototype swab

Injection molded polypropylene flocked nylon nasopharyngeal swab

Sponsors & Collaborators

  • University of Virginia

    lead OTHER

Principal Investigators

  • Amy Mathers, MD · University of Virginia

Study Design

Allocation
NON_RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
0 Years
Max Age
99 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-04-24
Primary Completion
2020-08-01
Completion
2020-08-01
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04368260 on ClinicalTrials.gov