Validation of HyperDetector for SARS-CoV-2
Sponsor
HyperSpectral APD (Industry)
Overall Status
Suspended
CT.gov ID
NCT05124496
Collaborator
(none)
10,000
1
12.6
792.6
Study Details
Study Description
Brief 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Study Design
Study Type:
Observational
Anticipated Enrollment
:
10000 participants
Observational Model:
Case-Only
Time Perspective:
Cross-Sectional
Official Title:
Validation of the HyperDetector Digital Solution Screening Assay for Rapid Screening for Potential SARS-CoV-2 (COVID-19) Infection
Actual Study Start Date
:
Dec 11, 2020
Anticipated Primary Completion Date
:
Dec 30, 2021
Anticipated Study Completion Date
:
Dec 30, 2021
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Comparison to Rt-PCR
|
Device: Screening Device
Screening device comparing Rt-PCR positive and negative results to HyperDetector results
|
Outcome Measures
Primary Outcome Measures
- Sensitivity [By 12/30/2022]
To determine the sensitivity of the screening assay
- Specificity [By 12/30/2022]
To determine the specificity of the screening assay
Eligibility Criteria
Criteria
Ages Eligible for Study:
5 Years
and Older
Sexes Eligible for Study:
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | HyperSpectral APD, LLC | Alexandria | Virginia | United States | 22314 |
Sponsors and Collaborators
- HyperSpectral APD
Investigators
- Study Director: Lauren Stack, HyperSpectral APD, LLC
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
HyperSpectral APD
ClinicalTrials.gov Identifier:
NCT05124496
Other Study ID Numbers:
- 20204146
First Posted:
Nov 18, 2021
Last Update Posted:
Nov 18, 2021
Last Verified:
Nov 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
Yes
Product Manufactured in and Exported from the U.S.:
Yes
Additional relevant MeSH terms: