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
Diagnostic Test: RT-PCR
The RT-PCR assay will be performed on paired nasopharyngeal and saliva 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
Ambry Genetics
Aliso Viejo, California, United States
Brigette Tippin Davis, PhD, Principal Investigator
Ambry Genetics