COVID-19 Diagnostic Self-testing Using Virtual Point-of-care
Communicable Disease, COVID-19, Sars-CoV2
About this trial
This is an interventional diagnostic trial for Communicable Disease focused on measuring COVIDscanDX, Antigen test, LAMP test, Diagnostic reader
Eligibility Criteria
Inclusion Criteria:
- 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,
Sites / Locations
- NeuroganicsRecruiting
Arms of the Study
Arm 1
Arm 2
Experimental
Sham Comparator
Positive-Antigen swab test for SARS-COV-2
Negative-Antigen swab test for SARS-COV-2
Subjects who have tested positive for the presence of SARS-COV-2 viral antigen using a rapid test or LAMP/PCR-based molecular test from nasal pharyngeal self-swab or a swab administered in a clinical setting at the point of care by a trained clinician. Parallel PCR-based testing occurs in an advanced laboratory to obtain Ct values for positive test results.
Subjects who have tested negative for the presence of SARS-COV-2 viral antigen using a rapid test or LAMP/PCR-based molecular nasal pharyngeal self-swab or a swab administered in a clinical setting by a trained clinician. PCR-based testing occurs in an advanced laboratory.