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

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

  • Covid19

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