The SARS-CoV-2 BioMedomics Rapid Antigen Screening Test (COV-SCAN) is an at-home rapidantigen COVID-19 antigen screening test device. The primary objectives of this study areto 1) Evaluate the clinical performance of COV-SCAN; 2.) Assess the usability of COV-SCANand the paired app as an over-the-counter product to be used by lay persons in non-laboratory settings. The clinical performance and usability data will be submitted aspart of an application for Emergency Use Authorization (EUA) to the FDA. 3) Assessacceptability and feasibility of the COV-SCAN test, paired app, and frequent testingregimen in demonstration projects in university and workforce settings.
The study will be divided into three segments 1) Clinical Evaluation; 2) Human Usability;
3) Demonstration. The design of each of these is described below.
1. Clinical Evaluation Study:
The Clinical Evaluation Study will use standard methods for assessing clinical
agreement between the assay we are testing and comparator molecular assay that
already has EUA. Below, we provide greater detail on the methods and activities
within each component of the process, and then provide an explanation of our
analytic plan and approach.
2. Human Usability Study:
The Human Usability Study will be conducted using clinical ethnographic methods of
observation, semi-structured interviews, and survey review. In implementation
science, clinical ethnography has been used as a way to understand processes by
which interventions are delivered (including barriers and facilitators) as well as
fidelity to a given intervention model. Observation may be in person or via video
conferencing.
3. Demonstration Project:
Our demonstration project in the Columbia University community will offer COV-SCAN and
paired app to undergraduate students housed on the Columbia campus and to graduate
students living in Columbia-owned residences on the Morningside campus. Currently,
undergraduate students living on campus are required to get a weekly molecular based test
administered by Columbia Health through a surveillance testing site. Graduate students
are currently not required to routinely test, though maybe selected through a random
sample for testing, or may access testing voluntarily. They are required to do symptom
attestation through the ReOpen CU app in order to enter campus buildings. Through
recruitment methods detailed below, students will be invited to participate in the study.
Participation will entail every-other-day testing using the COV-SCAN kit and paired app
for a three month period and reporting on usability, acceptability, and feasibility at
timepoints.
Device: Rapid Antigen Screening Test
A point-of-care Rapid Antigen Screening Test (RAST) using a lateral flow immunoassay
platform with our partner, BioMedomics Inc. The BioMedomics RAST is a lateral flow
immunoassay that detects the nucleocapsid protein (NP) antigen of SARS-CoV-2 using a
double antibody sandwich assay. The test cassette contains one detection line (T) fixed
with anti-SARS-CoV-2 NP antibody and one quality control line (C) fixed with control
antibody. When the test sample is treated with lysis buffer and added to the sample well
of the test cassette, the fluid will move forward along the test strip via capillary
action. If the sample contains NP antigen at levels higher than the limit of detection,
the antigen will bind to the NP capture antibody as well as the immobilized detection
antibody on the membrane forming a red T line, indicating a positive result. A positive
signal at C line provides assurance that the fluid containing the sample material has
moved laterally in an appropriate fashion.
Inclusion Criteria:
Demonstration segment:
- Confirmed age of 18 years or older
- Current Columbia University student, matriculating through Spring 2020 (either
undergraduate or graduate)
- Affiliated with Columbia throughout study observation period and willingness to
provide consent
Exclusion Criteria:
Clinical Evaluation segment:
- Those unable or unwilling to provide consent to all aspects of the study
- Those who do not have the ability to speak and comprehend English or Spanish
Human Usability segment:
- Those with prior experience with self-collection or self-testing prior to COVID-19
- Those with prior medical or laboratory training
- Those unable or unwilling to provide consent to all aspects of the study
- Those who do not have the ability to speak and comprehend English or Spanish
Demonstration segment:
- Unable or unwilling to provide consent to all aspects of the study
- Any participant who will not be remaining affiliated with Columbia University for
the duration of the study
- Students who do not have the ability to speak and comprehend English or Spanish
- Students who do not own a smartphone.
Columbia University Medical Center
New York 5128581, New York 5128638, United States
Michael Yin, MD, MS, Principal Investigator
Columbia University