COVID-19 and SARS-CoV-2 Detection in Saliva

SARS -CoV-2 Detection in Saliva Samples: A Test Validation Protocol

This study aims to validate the use of human saliva as a substrate for an assay to detect SARS-CoV-2 and define accuracy, analytical sensitivity and specificity of the TaqPath RT-PCR test.

Study Overview

• Status: Completed
• Conditions: RNA Virus Infections
• Intervention / Treatment: Diagnostic test: RT-PCR

Detailed Description

Investigators will carry out validation of a laboratory assay to detect SARS-CoV-2 nucleic acids in human saliva samples. Data for the validation will include the test results from standard nasopharyngeal (NP) swabs (controls) AND matched saliva samples (experimental group) of individuals who are either known to be infected or at high risk of being infected. Investigators hypothesize that the performance of an assay designed specifically for saliva will not perform differently, as defined by a predetermined margin, from the standard assay performed on NP and other respiratory samples

• Study Type: Observational
• Enrollment (Actual): 67

Contacts and Locations

Study Locations

• United States
  • California
    • Aliso Viejo, California, United States, 92656
      • Ambry Genetics

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

The population will be comprised of individuals age 18 years or older who are willing and able to provide verbal consent to provide a saliva sample AND a NP swab. The number of participants required is estimated to be 300 individuals whose infection status is unknown or 50 infection positive individuals and 50 infection negative individuals. The population will generally be symptomatic for, or at high risk of COVID-19 disease by criteria set forth in local testing sites. In addition, investigators will collect paired NP swabs and saliva from an equivalent size cohort of individuals known or suspected to NOT be infected with SARS-CoV-2.

Description

Inclusion Criteria:

• Reads and understands English or Spanish
• Willing and able to provide consent
• Diagnosed with COVID-19 or at high risk of disease based on objective criteria

Exclusion Criteria:

• Unwilling or unable to provide consent.
• Pregnant female

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Positive for SARS-CoV-2; Individuals who are symptomatic for COVID 19 disease, at high risk of infection or part of a screening program will provide samples for analysis which may reveal a positive result.	Diagnostic test: RT-PCR; The RT-PCR assay will be performed on paired nasopharyngeal and saliva samples
Negative for SARS-CoV-2; Individuals who are symptomatic for COVID 19 disease, at high risk of infection or part of a screening program will provide samples for analysis which may reveal a negative result.	Diagnostic test: RT-PCR; The RT-PCR assay will be performed on paired nasopharyngeal and saliva samples

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Detection of COVID-19 SARs-CoV-2 in saliva samples versus nasopharyngeal samples	TaqPath RT-PCR assay performed on saliva compared to TaqPath RT-PCR performed on nasopharyngeal samples for assay accuracy, concordance, reproducibility/precision, analytical sensitivity and analytical specificity.	up to 7 days

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Reason for testing	Participants may be recruited from individuals presenting for various indications for testing including; followup testing after previous positive result, at risk healthcare worker, exposure to known positive or symptomatic, public facing worker or workplace hazards, employee based screening.	Baseline
Current symptom status	Participant is symptomatic or asymptomatic	Baseline
Current symptoms	Participant reports one or more of the following symptoms at baseline. Cough, Shortness of breath or difficulty breathing, fever, chills, muscle pain, sore throat, new loss of taste or smell, any nausea, vomiting or diarrhea.	Baseline
Prior symptoms	Participant reports one or more of the following symptoms at baseline. Cough, Shortness of breath or difficulty breathing, fever, chills, muscle pain, sore throat, new loss of taste or smell, any nausea, vomiting or diarrhea.	Baseline
Date of first symptom or number of days since first symptom.	Participant reports date of first symptom or number of days since first symptom.	Baseline
Previous test for COVID-19 and date of test.	Participant reported result (positive, negative, inconclusive) of previous test for COVID-19 and date of test .	Baseline

Collaborators and Investigators

• Sponsor: Ambry Genetics
• Collaborators: Crozer-Keystone Health System; St. Joseph Hospital of Orange; The Saratoga Hospital
• Investigators: Principal Investigator: Brigette Tippin Davis, PhD, Ambry Genetics

Study record dates

Study Major Dates

• Study Start (Actual): May 21, 2020
• Primary Completion (Actual): March 16, 2021
• Study Completion (Actual): August 5, 2021

Study Registration Dates

• First Submitted: May 19, 2020
• First Submitted That Met QC Criteria: August 17, 2020
• First Posted (Actual): August 18, 2020

Study Record Updates

• Last Update Posted (Actual): March 7, 2022
• Last Update Submitted That Met QC Criteria: March 4, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Keywords: Detection
• Additional Relevant MeSH Terms: Virus Diseases; Infections; RNA Virus Infections
• Other Study ID Numbers: COV_20_001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

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