Investigational Performance Evaluation of the Nanomix eLab® COVID-19 Rapid Antigen Panel With Samples From COVID-19 Positive and Negative Human Subjects
Completed
- Conditions
- Covid19
- Interventions
- Diagnostic Test: Nanomix eLab® COVID-19 Rapid Antigen Panel (non-interventional)
- Registration Number
- NCT04667442
- Lead Sponsor
- Nanomix
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 137
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
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description EUA RT-PCR negative Nanomix eLab® COVID-19 Rapid Antigen Panel (non-interventional) - EUA RT-PCR positive Nanomix eLab® COVID-19 Rapid Antigen Panel (non-interventional) -
- Primary Outcome Measures
Name Time Method 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.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Nanomix
🇺🇸Emeryville, California, United States