Validation of HyperDetector for SARS-CoV-2
Purpose
To evaluate the HyperDetector as a method to rapidly screen SARS-CoV-2 To determine the sensitivity and specificity of the screening assay performed on oral swab and saliva specimens, compared to a validated RT-PCR COVID-19 method using nasal or nasopharyngeal swabs and to separately collected nasal swabs, oral swabs, oral rinse and saliva samples. To determine the best workflow for using such an assay to reflex suspicious/positive samples to a validated RT-PCR COVID-19 assay.
Condition
- SARS-COV2 Infection
Eligibility
- Eligible Ages
- Over 5 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- Subjects at COVID-19 testing site for Rt-PCR test.
Exclusion Criteria
- Minors under the age of 5
Study Design
- Phase
- Study Type
- Observational
- Observational Model
- Case-Only
- Time Perspective
- Cross-Sectional
Arm Groups
Arm | Description | Assigned Intervention |
---|---|---|
Comparison to Rt-PCR |
|
Recruiting Locations
More Details
- NCT ID
- NCT05124496
- Status
- Suspended
- Sponsor
- HyperSpectral APD