Status:
UNKNOWN
COVID-19 Diagnostic Self-testing Using Virtual Point-of-care
Lead Sponsor:
Neuroganics LLC
Collaborating Sponsors:
Neuroganics Diagnostics LLC
Artron Laboratories Inc
Conditions:
Communicable Disease
COVID-19
Eligibility:
All Genders
18-99 years
Phase:
NA
Brief Summary
The goal of the research is to assess candidate COVID-19 rapid diagnostic tests (e.g. immunodiagnostic antibody tests, like Cellex qSARS-CoV-2 IgG/IgM Rapid Test, or antigen tests, like Turklab Test-I...
Detailed Description
Two Nasopharyngeal (NP) swabs will be collected from opposite nares by health care professionals at the POC from minimally 500 subjects enrolled at a minimum of 2 point- of-care (POC) clinical sites. ...
Eligibility Criteria
Inclusion
- Individuals who have experienced symptoms of COVID-19 and have been tested using a CDC approved or FDA registered and listed nucleic acid based test within 1 year of Feb 1, 2020.
- Individuals who have been clinically diagnosed or suspected to have had COVID-19.
- Individuals who are at the time of enrollment in the study currently or in the recent past (3 weeks) exhibiting symptoms of COVID-19.
- Individuals capable of performing a finger stick blood drop draw or saliva collection and placing it in a sample collection tube.
- Individuals that have interacted with a COVID-19 positive individual and are still exhibiting symptoms will be tested by a CDC approved or FDA registered nucleic acid based device.
- Individuals must be capable of navigating a mobile device to take an image of the test using the camera and enter information into fields on the device and wireless/cellular capability to upload one or more images to a website server.
Exclusion
- Individuals incapable of pricking their finger and placing a drop of blood into a sample well.
- Individuals who cannot navigate a mobile device and see the screen to navigate and enter information in fields or align the camera with the test image.
- Pregnant woman are not excluded if they meet the inclusion criteria and age requirements.
- Individuals with a deviated septum
- Cognitively impaired individuals resulting in the inability to provide informed consent,
Key Trial Info
Start Date :
April 16 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2022
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT04348864
Start Date
April 16 2020
End Date
April 1 2022
Last Update
March 23 2022
Active Locations (1)
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1
Neuroganics
Northglenn, Colorado, United States, 80260