Covid19
Conditions
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.
Interventions
DIAGNOSTIC_TESTNanomix eLab® COVID-19 Rapid Antigen Panel (non-interventional)
COVID-19 Rapid Antigen Diagnostic Test
Sponsors
Nanomix
Study design
Observational model
OTHER
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Demonstrate clinical agreement between an EUA RT-PCR methodology and the Nanomix eLab® COVID-19 Rapid Antigen Panel | Up to 1 year | An analysis of the result from subjects who have been or will be tested by EUA RT-PCR will be performed to establish the sensitivity by positive percent agreement (PPA) and the specificity by negative percent agreement (NPA) of the Nanomix eLab® COVID-19 Rapid Antigen Panel and a confirmatory EUA RT-PCR method. |
Countries
United States
Outcome results
None listed