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

Nanomix137 enrolled

Overview

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

Study Type

OBSERVATIONAL

Enrollment

137

Conditions

Covid19

Interventions

Nanomix eLab® COVID-19 Rapid Antigen Panel (non-interventional)DIAGNOSTIC_TEST

COVID-19 Rapid Antigen Diagnostic Test

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Nanomix

Emeryville, California, United States

Outcomes

Primary Outcomes

Demonstrate clinical agreement between an EUA RT-PCR methodology and the Nanomix eLab® COVID-19 Rapid Antigen Panel

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.

Time frame: Up to 1 year

Data from ClinicalTrials.gov

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