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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

67 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-05-21

Study Completion Date

2021-08-05

Brief Summary

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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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Detailed Description

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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

Conditions

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RNA Virus Infections

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

RT-PCR

Intervention Type DIAGNOSTIC_TEST

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.

RT-PCR

Intervention Type DIAGNOSTIC_TEST

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

Interventions

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RT-PCR

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

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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