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

March 4, 2022 updated by: Ambry Genetics

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
67

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Detection of COVID-19 SARs-CoV-2 in saliva samples versus nasopharyngeal samples
Time Frame: up to 7 days
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

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Reason for testing
Time Frame: Baseline
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
Time Frame: Baseline
Participant is symptomatic or asymptomatic
Baseline
Current symptoms
Time Frame: Baseline
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
Time Frame: Baseline
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.
Time Frame: Baseline
Participant reports date of first symptom or number of days since first symptom.
Baseline
Previous test for COVID-19 and date of test.
Time Frame: Baseline
Participant reported result (positive, negative, inconclusive) of previous test for COVID-19 and date of test .
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Ambry Genetics

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Crozer-Keystone Health System
St. Joseph Hospital of Orange
The Saratoga Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Brigette Tippin Davis, PhD, Ambry Genetics

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 21, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 16, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 5, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 19, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 17, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 18, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 7, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 4, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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