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

NCT04517682 | Completed

• 1 other identifier: COV_20_001
• Study Type: observational
• Target: 67
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

RNA Virus Infections

Keywords

Detection

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Reason for testing

  Baseline

• Current symptom status

  Baseline

• Current symptoms

  Baseline

Study Arms (2)

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

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

Interventions

RT-PCR DIAGNOSTIC_TEST

The RT-PCR assay will be performed on paired nasopharyngeal and saliva samples

Negative for SARS-CoV-2; Positive for SARS-CoV-2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• Unwilling or unable to provide consent.
• Pregnant female

Sponsors & Collaborators

• Ambry Genetics: lead
• The Saratoga Hospital: collaborator
• St. Joseph Hospital of Orange: collaborator
• Crozer-Keystone Health System: collaborator

Study Sites (1)

Ambry Genetics

Aliso Viejo, California, 92656, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

De-identified samples may be retained for 90 days.

MeSH Terms

Conditions

RNA Virus Infections

Interventions

COVID-19 Nucleic Acid Testing

Condition Hierarchy (Ancestors)

Virus Diseases; Infections

Intervention Hierarchy (Ancestors)

COVID-19 Testing; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques

Study Officials

• Brigette Tippin Davis, PhD

  Ambry Genetics

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 19, 2020
• First Posted: August 18, 2020
• Study Start: May 21, 2020
• Primary Completion: March 16, 2021
• Study Completion: August 5, 2021
• Last Updated: March 7, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)