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

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-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.

Conditions

• Communicable Disease
• COVID-19
• Sars-CoV2
• Infectious Disease
• Coronavirus
• Virus

Interventions

DIAGNOSTIC_TEST

COVID-19 Antigen/Antibody Rapid Testing, mobile device image capture and telemedicine support

An immunodiagnostic rapid (5-20 minute) test detects circulating antibodies in the blood, serum or plasma of individuals who have been infected with the novel coronavirus SARS-COV-2 as detected by rapid antigen test or LAMP/PCR-based molecular test taken from nasopharyngeal swab samples in the recent past.

OTHER

Telemedicine

Imaging of the test using the software application COVIDscanDX 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).

Sponsors & Collaborators

• Neuroganics Diagnostics LLC

  collaborator UNKNOWN

• Artron Laboratories Inc

  collaborator UNKNOWN

• AllBio Science Inc.

  collaborator UNKNOWN

• Turklab

  collaborator UNKNOWN

• Neuroganics LLC

  lead INDUSTRY

Principal Investigators

• Donald Cooper, Ph.D. · Neuroganics LLC

Study Design

Allocation

NON_RANDOMIZED

Purpose

DIAGNOSTIC

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

99 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2020-04-16

Primary Completion

2022-04-30

Completion

2022-04-30

FDA Device

Yes

Countries

• United States

Study Locations