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

• 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

Study Timeline

• Study Start: 2020-12-01
• Study First Submitted: 2020-12-10
• Study First Submitted QC: 2020-12-11
• Study First Posted: 2020-12-14
• Status Verified: 2021-12
• Primary Completion: 2021-12-14
• Study Completion: 2021-12-14
• Last Update Submitted: 2021-12-22
• Last Update Posted: 2021-12-27

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

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.

Trial Locations

Locations (1)

Nanomix; 🇺🇸 Emeryville, California, United States