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

RNA Virus Infections Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04517682
• Other study ID #: COV_20_001
• Status: Completed
• Start date: May 21, 2020
• Est. completion date: August 5, 2021

Study information

• Verified date: March 2022
• Source: Ambry Genetics
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 67
• Est. completion date: August 5, 2021
• Est. primary completion date: March 16, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• RNA Virus Infections

Intervention

Diagnostic Test:
• RT-PCR
The RT-PCR assay will be performed on paired nasopharyngeal and saliva samples

Locations

Country	Name	City	State
United States	Ambry Genetics	Aliso Viejo	California

Sponsors (4)

Lead Sponsor	Collaborator
Ambry Genetics	Crozer-Keystone Health System, St. Joseph Hospital of Orange, The Saratoga Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	Current symptom status	Participant is symptomatic or asymptomatic	Baseline
Other	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
Other	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
Other	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
Other	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
Primary	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