COVID-19 and SARS-CoV-2 Detection in Saliva
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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Detailed 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
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| 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. |
Diagnostic Test: RT-PCR
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. |
Diagnostic Test: RT-PCR
The RT-PCR assay will be performed on paired nasopharyngeal and saliva samples
|
Outcome Measures
Primary Outcome Measures
- Detection of COVID-19 SARs-CoV-2 in saliva samples versus nasopharyngeal samples [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 Outcome Measures
- Reason for testing [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.
- Current symptom status [Baseline]
Participant is symptomatic or asymptomatic
- Current symptoms [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.
- Prior symptoms [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.
- Date of first symptom or number of days since first symptom. [Baseline]
Participant reports date of first symptom or number of days since first symptom.
- Previous test for COVID-19 and date of test. [Baseline]
Participant reported result (positive, negative, inconclusive) of previous test for COVID-19 and date of test .
Eligibility Criteria
Criteria
Inclusion Criteria:
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Reads and understands English or Spanish
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Willing and able to provide consent
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Diagnosed with COVID-19 or at high risk of disease based on objective criteria
Exclusion Criteria:
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Unwilling or unable to provide consent.
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Pregnant female
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Ambry Genetics | Aliso Viejo | California | United States | 92656 |
Sponsors and Collaborators
- Ambry Genetics
- The Saratoga Hospital
- St. Joseph Hospital of Orange
- Crozer-Keystone Health System
Investigators
- Principal Investigator: Brigette Tippin Davis, PhD, Ambry Genetics
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- COV_20_001