COVID-19 Antibody Self-testing Using Virtual Point-of-care
Clara Health

COVID-19 Antibody Self-testing Using Virtual Point-of-care

Sponsored by Neuroganics


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.

About 
COVID-19

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.

How is this study designed?

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

Who is this study for?

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 are at the time of enrollment in the study currently or in the recent past (3 weeks) exhibiting symptoms of COVID-19.
  • Individuals that have interacted with a COVID-19 positive individual and are still exhibiting symptoms will be tested by the Colorado Department of Public Health with a CDC approved or FDA registered nucleic acid based device.

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.

* Additional criteria apply. Please speak with the study team for further information.

What should I expect?

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.

Other: Telemedicine 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

Connect with the study team

Thank you for your interest in advancing COVID-19 treatments.

Please fill out this contact form to be connected to a member of the study team. The following information that you enter will only be authorized to be shared with the research team conducting this specific study.

If you have any difficulties or questions, please contact our support specialists at [email protected]

Have questions or need help?

For general questions about COVID-19 clinical trials, please email [email protected] For study specific inquiries, submit the interest form and you'll be connected to the team.