Status:

COMPLETED

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

Lead Sponsor:

Ambry Genetics

Collaborating Sponsors:

The Saratoga Hospital

St. Joseph Hospital of Orange

Conditions:

RNA Virus Infections

Eligibility:

All Genders

18+ years

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.

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 nasopharyn...

Eligibility Criteria

Inclusion

  • 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

  • Unwilling or unable to provide consent.
  • Pregnant female

Key Trial Info

Start Date :

May 21 2020

Trial Type :

OBSERVATIONAL

Allocation :

ACTUAL

End Date :

August 5 2021

Estimated Enrollment :

67 Patients enrolled

Trial Details

Trial ID

NCT04517682

Start Date

May 21 2020

End Date

August 5 2021

Last Update

March 7 2022

Active Locations (1)

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Ambry Genetics

Aliso Viejo, California, United States, 92656