Trials / Completed
CompletedNCT04517682
COVID-19 and SARS-CoV-2 Detection in Saliva
SARS -CoV-2 Detection in Saliva Samples: A Test Validation Protocol
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 67 (actual)
- Sponsor
- Ambry Genetics · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Accepted
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.
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
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DIAGNOSTIC_TEST | RT-PCR | The RT-PCR assay will be performed on paired nasopharyngeal and saliva samples |
Timeline
- Start date
- 2020-05-21
- Primary completion
- 2021-03-16
- Completion
- 2021-08-05
- First posted
- 2020-08-18
- Last updated
- 2022-03-07
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT04517682. Inclusion in this directory is not an endorsement.