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

ArmDescriptionAssigned Intervention
Comparison to Rt-PCR
  • Device: Screening Device
    Screening device comparing Rt-PCR positive and negative results to HyperDetector results

Recruiting Locations

More Details

NCT ID
NCT05124496
Status
Suspended
Sponsor
HyperSpectral APD