Status:
COMPLETED
Investigational Performance Evaluation of the Nanomix eLab® COVID-19 Rapid Antigen Panel With Samples From COVID-19 Positive and Negative Human Subjects
Lead Sponsor:
Nanomix
Conditions:
Covid19
Eligibility:
All Genders
18+ years
Brief Summary
Prospective samples will be collected to evaluate the agreement between a EUA RT-PCR test as the comparator method against the Nanomix eLab® system.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 1 2020
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 14 2021
Estimated Enrollment :
137 Patients enrolled
Trial Details
Trial ID
NCT04667442
Start Date
December 1 2020
End Date
December 14 2021
Last Update
December 27 2021
Active Locations (1)
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1
Nanomix
Emeryville, California, United States, 94608