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| Name | Class |
|---|---|
| The Saratoga Hospital | UNKNOWN |
| St. Joseph Hospital of Orange | OTHER |
| Crozer-Keystone Health System | OTHER |
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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.
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
| |
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RT-PCR | Diagnostic Test | The RT-PCR assay will be performed on paired nasopharyngeal and saliva samples |
|
| Measure | Description | Time Frame |
|---|---|---|
| Detection of COVID-19 SARs-CoV-2 in saliva samples versus nasopharyngeal samples | 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. | up to 7 days |
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| Measure | Description | Time Frame |
|---|---|---|
| Reason for testing | 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. | Baseline |
Inclusion Criteria:
Exclusion Criteria:
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The population will be comprised of individuals age 18 years or older who are willing and able to provide verbal consent to provide a saliva sample AND a NP swab. The number of participants required is estimated to be 300 individuals whose infection status is unknown or 50 infection positive individuals and 50 infection negative individuals. The population will generally be symptomatic for, or at high risk of COVID-19 disease by criteria set forth in local testing sites. In addition, investigators will collect paired NP swabs and saliva from an equivalent size cohort of individuals known or suspected to NOT be infected with SARS-CoV-2.
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| Name | Affiliation | Role |
|---|---|---|
| Brigette Tippin Davis, PhD | Ambry Genetics | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ambry Genetics | Aliso Viejo | California | 92656 | United States |
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| ID | Term |
|---|---|
| D012327 | RNA Virus Infections |
| ID | Term |
|---|---|
| D014777 | Virus Diseases |
| D007239 | Infections |
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| ID | Term |
|---|---|
| D000087123 | COVID-19 Nucleic Acid Testing |
| ID | Term |
|---|---|
| D000086742 | COVID-19 Testing |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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De-identified samples may be retained for 90 days.
| Current symptom status |
Participant is symptomatic or asymptomatic |
| Baseline |
| Current symptoms | 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. | Baseline |
| Prior symptoms | 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. | Baseline |
| Date of first symptom or number of days since first symptom. | Participant reports date of first symptom or number of days since first symptom. | Baseline |
| Previous test for COVID-19 and date of test. | Participant reported result (positive, negative, inconclusive) of previous test for COVID-19 and date of test . | Baseline |
| D008919 | Investigative Techniques |