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

Status
Completed
Conditions
COVID19
Interventions

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

COVID-19 Rapid Antigen Diagnostic Test

Eligibility Criteria

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

Eligibility Gender
All
Eligibility Age
Minimum: 18 Years ~ Maximum: N/A
Countries
United States
Locations

Nanomix
Emeryville, California, United States

Investigators

Tina Landess, Study Director
Nanomix

Sponsors / Collaborators
Nanomix
NCT Number
NCT04667442
MeSH Terms
COVID-19