COVID19
Conditions
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.
Interventions
DEVICEControl swab
FDA-cleared nasopharyngeal swab
DEVICEPrototype swab
Injection molded polypropylene flocked nylon nasopharyngeal swab
Sponsors
University of Virginia
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Intervention model description
The primary objective of this study is to determine whether the newly designed nasopharyngeal swabs perform acceptably compared to standard swabs.
Eligibility
Sex/Gender
ALL
Age
0 Years to 99 Years
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| All Study Participants 40 subjects with either presumed positive COVID-19 status or presumed negative COVID-19 status were included in this study. Control and prototype nasopharyngeal swabs were collected from each subject. | 40 |
| Total | 40 |
Baseline characteristics
| Characteristic | All Study Participants | — |
|---|---|---|
| Age, Categorical <=18 years | 0 Participants | — |
| Age, Categorical >=65 years | 9 Participants | — |
| Age, Categorical Between 18 and 65 years | 31 Participants | — |
| Presumed COVID-19 Status Presumed COVID-19 Negative | 20 Participants | — |
| Presumed COVID-19 Status Presumed COVID-19 Positive | 20 Participants | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment United States | 40 participants | — |
| Sex: Female, Male Female | 20 Participants | — |
| Sex: Female, Male Male | 20 Participants | — |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 40 | 0 / 40 |
| other Total, other adverse events | 0 / 40 | 0 / 40 |
| serious Total, serious adverse events | 0 / 40 | 0 / 40 |
Outcome results
Primary
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.
Time frame: at time of enrollment
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Control Swab | Number of Subjects for Which the Prototype Swab and the Control Swab Provide the Same COVID-19 PCR Result | Positive Sample | 18 participants |
| Control Swab | Number of Subjects for Which the Prototype Swab and the Control Swab Provide the Same COVID-19 PCR Result | Negative Sample | 22 participants |
| Prototype Swab | Number of Subjects for Which the Prototype Swab and the Control Swab Provide the Same COVID-19 PCR Result | Positive Sample | 17 participants |
| Prototype Swab | Number of Subjects for Which the Prototype Swab and the Control Swab Provide the Same COVID-19 PCR Result | Negative Sample | 23 participants |