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

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

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.

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

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