Trials / Suspended
SuspendedNCT05124496
Validation of HyperDetector for SARS-CoV-2
Validation of the HyperDetector Digital Solution Screening Assay for Rapid Screening for Potential SARS-CoV-2 (COVID-19) Infection
- Status
- Suspended
- Phase
- —
- Study type
- Observational
- Enrollment
- 10,000 (estimated)
- Sponsor
- HyperSpectral APD · Industry
- Sex
- All
- Age
- 5 Years
- Healthy volunteers
- Accepted
Summary
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Screening Device | Screening device comparing Rt-PCR positive and negative results to HyperDetector results |
Timeline
- Start date
- 2020-12-11
- Primary completion
- 2021-12-30
- Completion
- 2021-12-30
- First posted
- 2021-11-18
- Last updated
- 2021-11-18
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT05124496. Inclusion in this directory is not an endorsement.