NOWDx Test for the Detection of Antibodies to COVID-19

February 28, 2024 updated by: NOWDiagnostics, Inc.
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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

129

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Tucson, Arizona, United States, 85712
        • Del Sol Research Management, LLC
    • Florida
      • West Palm Beach, Florida, United States, 33409
        • Comprehensive Clinical Research, LLC
    • Tennessee
      • Jackson, Tennessee, United States, 38305
        • Clinical Research Solutions, LLC

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Persons tested with investigational device
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
Device: NOWDx COVID-19 Test
The investigational device is the NOWDx COVID-19 Test.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Clinical Agreement Between NOWDx COVID-19 Test and Emergency Use Authorized or FDA Cleared Comparator.
Time Frame: 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.
1 day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

NOWDiagnostics, Inc.

Investigators

  • Principal Investigator: Beth L Cobb, NOWDiagnostics, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2020

Primary Completion (Actual)

December 31, 2020

Study Completion (Actual)

December 31, 2020

Study Registration Dates

First Submitted

August 31, 2020

First Submitted That Met QC Criteria

December 29, 2020

First Posted (Actual)

December 30, 2020

Study Record Updates

Last Update Posted (Actual)

March 1, 2024

Last Update Submitted That Met QC Criteria

February 28, 2024

Last Verified

October 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NOWDx COVID-19 Antibody POC

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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