COVID-19 SARS-CoV-2 RAST Study

NCT06452056 | Completed FDA Device

• 1 other identifier: AAAT4238
• Study Type: observational
• Target: 337
• Locations: 1 country
• Sites: 1

Brief Summary

The SARS-CoV-2 BioMedomics Rapid Antigen Screening Test (COV-SCAN) is an at-home rapid antigen COVID-19 antigen screening test device. The primary objectives of this study are to 1) Evaluate the clinical performance of COV-SCAN; 2.) Assess the usability of COV-SCAN and 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 as part of an application for Emergency Use Authorization (EUA) to the FDA. 3) Assess acceptability and feasibility of the COV-SCAN test, paired app, and frequent testing regimen in demonstration projects in university and workforce settings.

Conditions

SARS-CoV2 Infection

Outcome Measures

Primary Outcomes (3)

• Clinical Evaluation of COV-SCAN

  Evaluate the clinical performance of COV-SCAN; Determine the accuracy of the COV-SCAN test compared to the RT-PCR test.

  1 year

• Usability of COV-SCAN

  The usability of COV-SCAN will be analyzed using the Systems Usability Scale (SUS). The SUS is a validated, 10-item questionnaire with a 5-point Likert scale (1="strongly disagree" to 5="strongly agree"). The distribution of responses to each of the ten items will be visualized and summarized. Using standard scoring methodology, a SUS score ranging from 0 to 100 will be calculated, with a higher score indicating higher usability. The study will average individual SUS scores to obtain an average SUS score across study participants.

  2 years

• Feasibility of COV-SCAN

  Feasibility will be measured by the Acceptability of Intervention Measure (AIM), a four-item validated measure of perceived intervention acceptability with items scored from "Completely Disagree" to "Completely Agree" on a 5-point Likert scale. A higher score indicates higher feasibility.

  2 years

Study Arms (3)

Clinical Evaluation

Participants (N=170) will be divided into three categories: known to be COVID+ symptomatic (n=50); known to be COVID+ asymptomatic (n=20) and not known to have COVID n=100

Device: Rapid Antigen Screening Test

Human Usability

Participants not known to have COVID (n=180) will be observed by a trained observer either in person or by videomonitoring when performed in non laboratory, actual or simulated use environments. We will split our usability study into two sections including participants testing themselves (n=90) and participants testing another person (child or adult) (n=90).

Device: Rapid Antigen Screening Test

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.

Device: Rapid Antigen Screening Test

Interventions

Rapid Antigen Screening Test DEVICE

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.

Clinical Evaluation; Demonstration Project; Human Usability

Eligibility Criteria

• Age: 2 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Clinical Evaluation and Human Usability: Participants will be of varying education levels, race/ethnicities, genders and health statuses. Demonstration: Participants will be undergraduate students housed on Columbia University campus and graduate students living in Columbia Residential properties. CUIMC residential housing will not be included.

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Columbia University: lead

Study Sites (1)

Columbia University Medical Center

New York, New York, 10032, United States

Location

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Michael Yin, MD, MS

  Columbia University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 30, 2024
• First Posted: June 11, 2024
• Study Start: January 7, 2021
• Primary Completion: December 30, 2022
• Study Completion: December 30, 2022
• Last Updated: June 11, 2024

Record last verified: 2024-06

Locations

US (1)