Impact of Swab Site and Sample Collector on Testing Sensitivity for SARS-CoV-2 Virus in Symptomatic Individuals

Overview

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

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Retrospective
  • Study Primary Completion Date: March 23, 2020

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.

Interventions

  • 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.

Clinical Trial Outcome Measures

Primary Measures

  • 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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: N/A

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Dr. Deneen Vojta
  • Collaborator
    • Quest Diagnostics
  • Provider of Information About this Clinical Study
    • Sponsor-Investigator: Dr. Deneen Vojta, Executive Vice President and Chief Medical Officer, UHG R&D – UnitedHealth Group
  • Overall Official(s)
    • Ethan Berke, MD, Principal Investigator, UnitedHealth Group

Citations Reporting on Results

Coronavirus Disease 2019 (COVID-19) in the US. Centers for Disease Control and Prevention, accessed March 13, 2020. https://www.cdc.gov/coronavirus/2019-ncov/cases-in-us.html

Personal communication per Dr. Scott Lindquist, MD State of Washington Epidemiologist (March 2020

Anderson RM, Heesterbeek H, Klinkenberg D, Hollingsworth TD. How will country-based mitigation measures influence the course of the COVID-19 epidemic? Lancet. 2020 Mar 21;395(10228):931-934. doi: 10.1016/S0140-6736(20)30567-5. Epub 2020 Mar 9.

Frazee BW, Rodríguez-Hoces de la Guardia A, Alter H, Chen CG, Fuentes EL, Holzer AK, Lolas M, Mitra D, Vohra J, Dekker CL. Accuracy and Discomfort of Different Types of Intranasal Specimen Collection Methods for Molecular Influenza Testing in Emergency Department Patients. Ann Emerg Med. 2018 Apr;71(4):509-517.e1. doi: 10.1016/j.annemergmed.2017.09.010. Epub 2017 Nov 24.

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