NOWDx Test for the Detection of Antibodies to COVID-19

Not Applicable

Completed

• Conditions: COVID-19; SARS-CoV-2; Coronavirus
• Interventions: Device: NOWDx COVID-19 Test

• Registration Number: NCT04690413
• Lead Sponsor: NOWDiagnostics, Inc.

Brief 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).

Detailed 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 Timeline

• Study First Submitted: 2020-08-31
• Study Start: 2020-09-01
• Study First Submitted QC: 2020-12-29
• Study First Posted: 2020-12-30
• Primary Completion: 2020-12-31
• Study Completion: 2020-12-31
• Results First Submitted: 2022-04-04
• Status Verified: 2022-10
• Results First Submitted QC: 2022-10-26
• Results First Posted: 2022-10-28
• Last Update Submitted: 2024-02-28
• Last Update Posted: 2024-03-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 129

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Persons tested with investigational device	NOWDx COVID-19 Test	Persons tested with investigational device who previously tested positive or negative for COVID-19 with an emergency use authorized or FDA cleared COVID-19 test

Primary Outcome Measures

Name	Time	Method
Percentage of Clinical Agreement Between NOWDx COVID-19 Test and Emergency Use Authorized or FDA Cleared Comparator.	1 day	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.

Trial Locations

Locations (3)

Comprehensive Clinical Research, LLC; 🇺🇸 West Palm Beach, Florida, United States

Clinical Research Solutions, LLC; 🇺🇸 Jackson, Tennessee, United States

Del Sol Research Management, LLC; 🇺🇸 Tucson, Arizona, United States