Impact of Swab Site and Sample Collector on Testing Sensitivity for COVID-19 Virus in Symptomatic Individuals

Study Overview
=================
Brief Summary
-----------------
Operational project to compare clinician collected nasopharyngeal (NP) samples to patient-obtained tongue, nasal and mid-turbinate (MT) samples in the detection of SARS-CoV-2 in an outpatient clinic setting

Detailed Description
-----------------
This work will serve both the Everett Clinic and broader UnitedHealth Group patient populations as well as advance the public health emergency (PHE) response to the community spread of SARS-CoV-2 virus, especially as the number of cases and deaths continues to rise in many geographies. Leveraging our presence in the Seattle/Puget Sound area with Everett Clinic, we intend to develop a model that can screen a large number of patients at varying levels of risk and manifestation of clinical symptoms while conserving personal protective equipment (PPE) and decreasing transmission risk to health care workers. This will also serve to support the enterprise and public health response. Towards this goal, we must first assess the equivalence between clinician-collected nasopharyngeal (NP) samples to patient-collected tongue, nasal, and mid-turbinate (MT) samples to detect SARS-CoV-2 across a broad cross-section of the population.

Official Title
-----------------
Impact of Swab Site and Sample Collector on Testing Sensitivity for COVID-19 Virus in Symptomatic Individuals

Conditions
-----------------
Infections, Respiratory, Fever, Cough

Intervention / Treatment
-----------------
* Diagnostic Test: Testing Sensitivity for SARS-CoV-2 Virus in Symptomatic Individuals


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Able to consent and agree to participate in the project after discussing the project Coming to The Everett Clinic during the operational project duration Evidence of upper respiratory symptoms suggesting higher risk of testing positive for SARS-CoV-2 virus. Exclusion Criteria: Not able to demonstrate understanding of the study Not willing to commit to having all four samples collected Medical history evidencing any of the following Active nosebleed in the past 24 hours Nasal surgery in the past two weeks Chemotherapy treatment with low platelet and low white blood cell counts Acute facial trauma
Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Intervention/Treatment |
| --- |
|Diagnostic Test: Testing Sensitivity for SARS-CoV-2 Virus in Symptomatic Individuals|This is an operational project. Patients will collect a sample from the tongue, nasal cavity and MT and then clinicians will collect a NP sample from the nostril corresponding to each participant's dominant hand.|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Accuracy of patient administered tests | compare clinician collected nasopharyngeal (NP) samples to patient-obtained tongue, nasal and mid-turbinate (MT) samples in the detection of SARS-CoV-2 in an outpatient clinic setting | 2 weeks |