NOWDx Test for the Detection of Antibodies to COVID-19

Status Completed

Clinical Trial Summary

Clinical Trial Description

This study is designed to compare the performance of the NOWDx COVID-19 Test to an emergency use authorized PCR test result. The intent is to show the rapid test device is comparable to a currently marketed device. The NOWDx COVID-19 Test is an in vitro lateral flow immunoassay intended for qualitative detection of total antibodies to SARS-CoV-2 in human whole blood (venous and fingerstick). The NOWDx COVID-19 Test is intended for use as an aid in identifying individuals with an adaptive immune response to SARS-CoV-2, indicating recent or prior infection. At this time, it is unknown for how long antibodies persist following infection and if the presence of antibodies confers protective immunity. Testing of human venous whole blood (EDTA) and fingerstick specimens are intended to be conducted in patient care settings authorized to perform CLIA waived tests. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT04690413
Study type	Interventional
Source	NOWDiagnostics, Inc.
Contact
Status	Completed
Phase	N/A
Start date	September 1, 2020
Completion date	December 31, 2020

View Details

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