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.
Two Nasopharyngeal (NP) swabs will be collected from opposite nares by health care
professionals at the POC from minimally 500 subjects enrolled at a minimum of 2 point-
of-care (POC) clinical sites. One swab will be tested for the presence of SARS-CoV-2
responsible for COVID -19 using antigen-based tests. A second swab will be placed in
transport media and transferred to a laboratory for testing using a high sensitivity EUA
real-time (RT) PCR assay as the comparator method and the Ct values used to determine
positive or negative. The order of sample collection will be randomized.
Serial testing for home use of the Test-It (Turklab) COVID-19 Rapid Antigen test will be
tested in symptomatic and asymptomatic subjects.
Positive tests will be tested for SARS-CoV-2 variant using Whole Genome Sequencing Method by
Amplicon-Based NGS (Quest Diagnostics).
Two to 4 health care professional operators per site, with a range of education and training,
at a point of care setting will perform a COVID-19 Rapid test assay utilizing the
Instructions for Use and/or Quick Reference Instruction.
Sample Population: Males and females, age 2 and older, with or without symptoms consistent
with SARS-CoV-2 infection (COVID-19).
Outcome measures: 1) Sensitivity and specificity will be calculated for comparison of results
between the Rapid test and the high sensitivity EUA real-time (RT) PCR assay comparator. 2)
Evidence that a Health Care Professional (HCP) at Point of Care (POC) can safely and
effectively utilize the Rapid test and the COVIDscanDX reader after reading the Instructions
For Use (IFU) and/or brief instruction video.
Antibody testing will be performed after PCR/antigen testing or after vaccination with and
FDA EUA allowed SARS-CoV-2 vaccine. A finger-stick blood drop, nasopharyngeal swab or saliva
sample in buffer is applied to a lateral flow test to measure either SARS-CoV-2 antigen or
IgM and IgG antibodies either once or up to five times separated by a week for 35 days after
vaccination. Follow-up tests may be performed to measure the longevity of the antibody
response over time up to a year.
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 Name: COVID-19 diagnostic rapid testing reader and software validation
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).
Other Name: virtual point-of-care
- 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,
- 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
- 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
- Individuals with a deviated septum
- Cognitively impaired individuals resulting in the inability to provide informed
Northglenn, Colorado, United States
Investigator: Donald Cooper, Ph.D.
Donald Cooper, Ph.D., Principal Investigator