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OpenTrials
Completed

NCT Number: NCT04517682

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

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.

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Key information

Conditions

RNA Virus Infections Infections Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Ambry Genetics

Aliso Viejo, California, 92656, United States

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

RT-PCR

Diagnostic Test

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

Primary outcomes

  1. 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.

Other outcomes

  1. 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.

  2. Current symptom status

    Time frame: Baseline

    Participant is symptomatic or asymptomatic

  3. 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.

  4. 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.

  5. 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.

  6. 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 .

Sponsors and collaborators

Lead sponsor

Ambry Genetics

Industry

Collaborators

  • Crozer-Keystone Health System
  • St. Joseph Hospital of Orange
  • The Saratoga Hospital

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Aug 18, 2020
Registry last updated
Mar 7, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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