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NCT04690413 Clinical Trial

NOWDx Test for the Detection of Antibodies to COVID-19

COVID-19 Clinical Trial

Official title:
NOWDx Test for the Detection of Antibodies to COVID-19

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04690413
Other study ID # NOWDx COVID-19 Antibody POC
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date September 1, 2020
Est. completion date December 31, 2020

Study information
Verified date October 2022
Source NOWDiagnostics, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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).

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.

Recruitment information / eligibility
Status Completed
Enrollment 129
Est. completion date December 31, 2020
Est. primary completion date December 31, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Persons =18 years old; - Persons who have tested positive or negative (within 6 days) for COVID-19 with an emergency use authorized molecular (PCR) test and can furnish said test report. Exclusion Criteria: - Persons <18 years old; - Persons who have previously participated in a NOWDx study.

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• NOWDx COVID-19 Test
The investigational device is the NOWDx COVID-19 Test.

Locations
Country Name City State
United States Clinical Research Solutions, LLC Jackson Tennessee
United States Del Sol Research Management, LLC Tucson Arizona
United States Comprehensive Clinical Research, LLC West Palm Beach Florida

Sponsors (1)
Lead Sponsor Collaborator
NOWDiagnostics, Inc.

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Percentage of Clinical Agreement Between NOWDx COVID-19 Test and Emergency Use Authorized or FDA Cleared Comparator. Calculate positive percent agreement (PPA) and negative percent agreement (NPA) between NOWDx COVID-19 Test and emergency use authorized or FDA cleared COVID-19 PCR Test. 1 day
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