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Validation of HyperDetector for SARS-CoV-2

NCT ID: NCT05124496

Last Updated: 2021-11-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

SUSPENDED

Total Enrollment

10000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-12-11

Study Completion Date

2021-12-30

Brief Summary

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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.

Detailed Description

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Conditions

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SARS-COV2 Infection

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Comparison to Rt-PCR

Screening Device

Intervention Type DEVICE

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

Interventions

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Screening Device

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

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* Minors under the age of 5
Minimum Eligible Age

5 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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HyperSpectral APD

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Lauren Stack

Role: STUDY_DIRECTOR

HyperSpectral APD, LLC

Locations

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HyperSpectral APD, LLC

Alexandria, Virginia, United States

Site Status

Countries

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United States

Other Identifiers

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20204146

Identifier Type: -

Identifier Source: org_study_id