The goal of the research is to assess candidate COVID-19 rapid (5-15 min) antibody 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 a mobile device camera acquisition software and telemedicine clinical/technical support (virtual point-of-care) improves the ease of use and interpretation of the tests, thus making self-testing comparable in accuracy and safety to testing in a clinical setting.
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 finger-stick capillary blood self-testing assisted by mobile device imaging and telemedicine remote support.
Coronavirus disease 2019 (COVID-19) is a respiratory illness that can spread from person to person. The virus that causes COVID-19 is a novel coronavirus that was first identified during an investigation into an outbreak in Wuhan, China.
Study Type: Interventional (Clinical Trial)
Estimated Enrollment: 100 participants
Primary Purpose: Diagnostic
Actual Study Start Date: April 16, 2020
Estimated Study Completion Date: April 2021
* Additional criteria apply. Please speak with the study team for further information.
Subjects who have tested positive for the presence of SARS-COV-2 viral antigen using nasal pharyngeal self-swab or a swab administered in a clinical setting by a trained clinician. PCR-based testing occurs in an advanced laboratory.
Diagnostic Test: COVID-19 IgM/IgG Rapid Testing, mobile device image capture and telemedicine support
An immunodiagnostic rapid (5-20 minute) test detects circulating antibodies (IgM and IgG) in the blood, serum or plasma of individuals who have been infected with the novel coronavirus SARS-COV-2 in the past.
Imaging of the test and upload to server by the subject and phone, video or messaging consult with a clinician for interpretation and instructions establishes the telemedicine (i.e. virtual point-of-care).
Other Name: virtual point-of-care
Thank you for your interest in advancing COVID-19 treatments.
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