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

Nanomix

Status: Completed

Conditions: Covid19

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

Study type: Observational

Funder types: Industry

Identifiers

NCT04667442

Nanomix CVAG-202

Details and patient eligibility

About

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

Enrollment: 137 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

137 participants in 2 patient groups

EUA RT-PCR positive

Treatment:

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

EUA RT-PCR negative

Treatment:

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