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

NCT04667442 | Completed FDA Device

• 1 other identifier: Nanomix CVAG-202
• Study Type: observational
• Target: 137
• Locations: 1 country
• Sites: 1

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.

Conditions

Covid19

Outcome Measures

Primary Outcomes (1)

• 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.

  Up to 1 year

Study Arms (2)

EUA RT-PCR positive

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

EUA RT-PCR negative

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

Interventions

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

COVID-19 Rapid Antigen Diagnostic Test

EUA RT-PCR negative; EUA RT-PCR positive

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

The study population will include both symptomatic and asymptomatic subjects. Although to enrich for COVID-19 positive subjects, the study will preferentially identify and enrolled subjects who have been or will be tested by EUA RT-PCR including those who are symptomatic or hospitalized with symptoms, specifically those within 7-days of symptom onset that meet the study enrollment inclusion and exclusion criteria.

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Nanomix: lead

Study Sites (1)

Nanomix

Emeryville, California, 94608, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Nasal sample (without cells/ RNA/DNA) will be aliquoted and stored at Sponsor for potential future analysis/ projects.

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Tina Landess

  Nanomix

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 10, 2020
• First Posted: December 14, 2020
• Study Start: December 1, 2020
• Primary Completion: December 14, 2021
• Study Completion: December 14, 2021
• Last Updated: December 27, 2021

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)