COVID-19 Tests With Saliva Specimens

Upper respiratory swabs, such as the nasopharyngeal (NP) swab, have so far been major specimen sources used for the SARS-COV-2 molecular test. However, due to the discomfort and invasiveness of NP collection, and the expense of personal protective equipment, alternative sampling sources such as saliva are desired. The purpose of this proposed study is: 1) to examine whether saliva can be used as an specimen for the SARS-COV-2 molecular test; 2) to test if gingival crevicular fluids is a reliable specimen for the SARS-COV-2 antibodies.

Study Overview

• Status: Unknown
• Conditions: Covid19
• Intervention / Treatment: Other: Saliva collection

• Study Type: Interventional
• Enrollment (Anticipated): 2000
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Tucson, Arizona, United States, 85712
      • Paradigm Laboratories

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Persons referred for COVID-19 testing including those with COVID-19 symptoms and/or a suspected SARS-COV-2 infection or undergoing surveillance testing and

  • Is able to give informed consent
  • Is able to understand oral or written instructions, and
  • Is able to mentally and physically perform self-collection of saliva using the provided collection device.

Exclusion Criteria:

• - Adults unable to consent
• Individuals who are not yet adults (infants, children, teenagers)
• Employees of Paradigm lab and the assisted living facilities involved in the study
• Members of other vulnerable populations

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Saliva and NP paired specimen collection	Other: Saliva collection; Use Spectrum Solutions SDNA1000 or Orasure collection kit or dry tube to collect 1-3 ml of saliva

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The clinical evaluation of saliva as specimen for COVID-19 molecular test	We will evaluate the positive and negative agreement of saliva with nasopharyngeal swab as specimens for COVID-19 molecular test.	1 hour

Collaborators and Investigators

• Sponsor: Paradigm Laboratories LLC
• Investigators: Principal Investigator: Wenli Zhou, PhD, Paradigm Laboratories

Study record dates

Study Major Dates

• Study Start (Actual): July 28, 2020
• Primary Completion (Anticipated): January 30, 2021
• Study Completion (Anticipated): June 27, 2021

Study Registration Dates

• First Submitted: September 25, 2020
• First Submitted That Met QC Criteria: September 25, 2020
• First Posted (Actual): September 29, 2020

Study Record Updates

• Last Update Posted (Actual): September 29, 2020
• Last Update Submitted That Met QC Criteria: September 25, 2020
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19
• Other Study ID Numbers: PLRD202001

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No