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Validation of HyperDetector for SARS-CoV-2

NCT05124496 · Status: SUSPENDED · Type: OBSERVATIONAL · Enrollment: 10000

Last updated 2021-11-18

No results posted yet for this study

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

  • SARS-COV2 Infection

Interventions

DEVICE

Screening Device

Screening device comparing Rt-PCR positive and negative results to HyperDetector results

Sponsors & Collaborators

  • HyperSpectral APD

    lead INDUSTRY

Principal Investigators

  • Lauren Stack · HyperSpectral APD, LLC

Eligibility

Min Age
5 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-12-11
Primary Completion
2021-12-30
Completion
2021-12-30
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05124496 on ClinicalTrials.gov