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

Not Applicable

Completed

• Conditions: COVID19
• Interventions: Device: Prototype swab; Device: Control swab

• Registration Number: NCT04368260
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-04-24
• Study First Submitted: 2020-04-24
• Study First Submitted QC: 2020-04-27
• Study First Posted: 2020-04-29
• Primary Completion: 2020-08-01
• Study Completion: 2020-08-01
• Status Verified: 2022-02
• Results First Submitted: 2022-02-09
• Results First Submitted QC: 2022-02-09
• Last Update Submitted: 2022-02-09
• Results First Posted: 2022-02-17
• Last Update Posted: 2022-02-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Prototype swab	Prototype swab	Injection molded polypropylene flocked nylon NP swab
Control swab	Control swab	FDA cleared swab

Primary Outcome Measures

Name	Time	Method
Number of Subjects for Which the Prototype Swab and the Control Swab Provide the Same COVID-19 PCR Result	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.

Trial Locations

Locations (1)

University of Virginia; 🇺🇸 Charlottesville, Virginia, United States