NCT04368260

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: University of Virginia · Academic / Other
• Sex: All
• Age: 0 Years – 99 Years
• Healthy volunteers: Accepted

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

Type	Name	Description
DEVICE	Control swab	FDA-cleared nasopharyngeal swab
DEVICE	Prototype swab	Injection molded polypropylene flocked nylon nasopharyngeal swab

Timeline

• Start date: 2020-04-24
• Primary completion: 2020-08-01
• Completion: 2020-08-01
• First posted: 2020-04-29
• Last updated: 2022-02-17
• Results posted: 2022-02-17

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study