COVID-19 Diagnostic Self-testing Using Virtual Point-of-care
Status unconfirmed · Not applicable
Conditions studied: Communicable Disease, COVID-19, Sars-CoV2, Infectious Disease, Coronavirus, Virus
In brief
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-It COVID-19 Home Test, AllBio Science Inc. and Artron Laboratories Inc. rapid COVID-19 antigen tests in order to judge their clinical accuracy compared to Centers for Disease Control (CDC)-recommended molecular genetic testing and clinical diagnosis. Second, it is our goal to determine if self-testing assisted by COVIDscanDX mobile device camera acquisition software platform and telemedicine clinical/technical support (virtual point-of-care) improves the ease of use and immediate interpretation of the tests, thus making self-testing comparable in accuracy and safety to testing in a clinical setting. Third, we are testing antibodies to SARS-CoV-2 after diagnosis with COVID-19 or following vaccination to measure the onset and time course of detectable antibodies from finger-stick blood drops and rapid antibody lateral flow tests. The overall purpose of the study is to dramatically increase the capacity of COVID-19 testing by establishing the safety, ease-of-use and validity of self-testing assisted by mobile device imaging and telemedicine remote support and provide evidence of antibody time-course response to vaccination.
Key facts
- Study ID
- NCT04348864
- Run by
- Neuroganics LLC
- People needed
- 200
- Starts
- 2020-04-16
- Expected to finish
- 2022-04-01
- Last updated by the study team
- 2022-03-23
Who can join
Age: 18 and older, up to 99. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 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 Criteria: 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,
Where it is running
- Neuroganics — Northglenn, Colorado, United States (enrolling)
Full record on ClinicalTrials.gov
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