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

Ambry Genetics

Status: Completed

Conditions: RNA Virus Infections

Treatments: Diagnostic Test: RT-PCR

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT04517682

COV_20_001

Details and patient eligibility

About

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.

Full 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

Enrollment: 67 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

67 participants in 2 patient groups

Positive for SARS-CoV-2

Description:

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.

Treatment:

Diagnostic Test: RT-PCR

Negative for SARS-CoV-2

Description:

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.

Treatment:

Diagnostic Test: RT-PCR