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Purpose

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

Condition

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
Yes

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

Study Design

Phase
Study Type
Observational
Observational Model
Other
Time Perspective
Cross-Sectional

Arm Groups

ArmDescriptionAssigned Intervention
EUA RT-PCR positive
  • Diagnostic Test: Nanomix eLab® COVID-19 Rapid Antigen Panel (non-interventional)
    COVID-19 Rapid Antigen Diagnostic Test
EUA RT-PCR negative
  • Diagnostic Test: Nanomix eLab® COVID-19 Rapid Antigen Panel (non-interventional)
    COVID-19 Rapid Antigen Diagnostic Test

Recruiting Locations

More Details

NCT ID
NCT04667442
Status
Completed
Sponsor
Nanomix

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.