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

Study Overview
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Brief Summary
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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.

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

Conditions
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COVID19

Intervention / Treatment
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* Device: Control swab
* Device: Prototype swab


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 0 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: The primary objective of this study is to determine whether the newly designed nasopharyngeal swabs perform acceptably compared to standard swabs.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Control swab<br>FDA cleared swab | Device: Control swab<br>* FDA-cleared nasopharyngeal swab<br>|
| Experimental: Prototype swab<br>Injection molded polypropylene flocked nylon NP swab | Device: Prototype swab<br>* Injection molded polypropylene flocked nylon nasopharyngeal swab<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Subjects for Which the Prototype Swab and the Control Swab Provide the Same COVID-19 PCR Result | 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. | at time of enrollment |