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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04517682
Other study ID # COV_20_001
Secondary ID
Status Completed
Phase
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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