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Investigational Performance Evaluation of the Nanomix eLab® COVID-19 Rapid Antigen Panel With Samples From COVID-19 Positive and Negative Human Subjects

NCT ID: NCT04667442

Last Updated: 2021-12-27

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

COMPLETED

Total Enrollment

137 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-12-01

Study Completion Date

2021-12-14

Brief Summary

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Prospective samples will be collected to evaluate the agreement between a EUA RT-PCR test as the comparator method against the Nanomix eLab® system.

Detailed Description

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Conditions

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Covid19

Study Design

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Observational Model Type

OTHER

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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EUA RT-PCR positive

Nanomix eLab® COVID-19 Rapid Antigen Panel (non-interventional)

Intervention Type DIAGNOSTIC_TEST

COVID-19 Rapid Antigen Diagnostic Test

EUA RT-PCR negative

Nanomix eLab® COVID-19 Rapid Antigen Panel (non-interventional)

Intervention Type DIAGNOSTIC_TEST

COVID-19 Rapid Antigen Diagnostic Test

Interventions

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Nanomix eLab® COVID-19 Rapid Antigen Panel (non-interventional)

COVID-19 Rapid Antigen Diagnostic Test

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

* 18 years of age or older
* Male or Female
* Willing and able to provide informed consent
* Symptomatic or asymptomatic
* The EUA RT-PCR sample must be collected within one (1) day of the sample collected for testing by the Nanomix eLab® COVID-19 Rapid Antigen Panel.

Exclusion Criteria

* Subjects without both a valid EUA RT-PCR test result and a valid Nanomix eLab® COVID-19 Rapid Antigen results will be excluded
* Subjects not being able to provide consent
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Nanomix

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Tina Landess

Role: STUDY_DIRECTOR

Nanomix

Locations

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Nanomix

Emeryville, California, United States

Site Status

Countries

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United States

Other Identifiers

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Nanomix CVAG-202

Identifier Type: -

Identifier Source: org_study_id