Validation of HyperDetector for SARS-CoV-2

HyperSpectral APD

Status: Suspended

Conditions: SARS-COV2 Infection

Treatments: Device: Screening Device

Study type: Observational

Funder types: Industry

Identifiers

NCT05124496

20204146

Details and patient eligibility

About

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.

Enrollment: 10,000 estimated patients

Sex: All

Ages: 5+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Subjects at COVID-19 testing site for Rt-PCR test.

Exclusion criteria

• Minors under the age of 5

Trial design

10,000 participants in 1 patient group

Comparison to Rt-PCR

Treatment:

Device: Screening Device