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

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

Completed

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Key information

Conditions

Infections, Respiratory Body Temperature Changes Cough Fever Infections Pathological Conditions, Signs and Symptoms Respiration Disorders Respiratory Tract Diseases Respiratory Tract Infections Signs and Symptoms Signs and Symptoms, Respiratory

Sex eligibility

All sexes

Study type

Observational

Primary location

Everett Clinic

Seattle, Washington, 98133, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Testing Sensitivity for SARS-CoV-2 Virus in Symptomatic Individuals

Diagnostic Test

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.

Primary outcomes

Accuracy of patient administered tests

Time frame: 2 weeks

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

Sponsors and collaborators

Lead sponsor

UnitedHealth Group

Industry

Collaborators

Bill and Melinda Gates Foundation
Quest Diagnostics-Nichols Insitute

Registry information

Important dates

Study start: 2020
Primary completion: 2020
Study completion: 2020
First posted: Mar 25, 2020
Registry last updated: May 4, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed