Sensitivity of Frequent SARS-CoV-2 (COVID-19) Rapid Antigen Testing Regimen

Comparison of Screening for SARS-CoV-2 (COVID-19) in a Low Prevalence Setting Using Serial Antigen Testing Versus Serial Molecular (PCR) Testing

This study aims to assess how an at-home COVID-19 frequent testing regimen using the CoV-SCAN test kit and a paired phone application to help interpret the test result compares to once-a-week or three-times-a-week polymerase chain reaction (PCR) (molecular) testing to identify a SARS-CoV-2 infection.

Employees and cast members at Media and Entertainment Company and its affiliates will be recruited to test whether frequent use of CoV-SCAN will perform as well or better than weekly molecular testing and at least as well as three-times-a-week molecular testing.

Study Overview

• Status: Terminated
• Conditions: Covid19
• Intervention / Treatment: Device: CoV-SCAN rapid COVID-19 antigen test

Detailed Description

Antigen tests are simple to perform, have a rapid turn-around time of 15-30 minutes, and a lower cost than molecular tests. Because antigen tests do not incorporate an amplification step, they are intrinsically less sensitive than PCR molecular tests. Nevertheless, several investigators have examined the feasibility of screening populations of individuals in a low SARS-CoV-2 infection prevalence situation, such as the workplace or schools, with rapid antigen tests in place of the molecular tests. Using viral kinetics, knowledge of what level of viral load is required for transmission of culture-competent virus, test sensitivity and modeling, they have come to the conclusion that more frequent testing with a test with lower sensitivity that has a quick turn-around time is better than a test with high sensitivity with a longer turn-around time. Therefore, the goal of this study is to test the hypothesis that frequent testing with a relatively sensitive lateral flow antigen test performed at home using self-collected anterior nasal swabs will be superior to once a week or less PCR testing and non-inferior to three times a week PCR testing in an employment screening setting with a relatively low incidence of new SARS-CoV-2 infections. This study aims to assess how an at-home COVID-19 frequent testing regimen using a Rapid Antigen Screening Test (RAST) and a phone application to help interpret the test result compares to once-a-week or three-times-a-week PCR (molecular) testing to identify a SARS-CoV-2 infection. We expect to recruit up to 4,400 employees and cast members of Media and Entertainment Company and its affiliates to test whether frequent use of the RAST will perform as well or better than weekly molecular testing and at least as well as three-times-a-week molecular testing. Recruitment and the study will continue until at least 31 or at most 148 true positive SARS-CoV-2 molecular results are reached.

• Study Type: Observational
• Enrollment (Actual): 93

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10032
      • Columbia University Irving Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Employees and cast members of a Media and Entertainment Company

Description

Inclusion Criteria:

• Aged 18 years or older;
• Have a smartphone;
• Understand and read English;
• Will be on one production location for at least three weeks following enrollment to the study;
• Will be willing to be contacted by the Study Coordinator after leaving one production location to facilitate continued access to weekly molecular testing;

Exclusion Criteria:

• Have received any dose of COVID-19 vaccination;
• Have been diagnosed with COVID-19 infection.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sensitivity of CoV-SCAN daily testing regimen	To compare the sensitivity (the percentage of people with the disease who test positive) of the rapid antigen testing regimen to the gold standard PCR testing regimen	Baseline to 21 days
Specificity of CoV-SCAN daily testing regimen	To compare the specificity (the ability of the test to correctly identify those without the disease) of the rapid antigen testing regimen to the gold standard PCR testing regimen	Baseline to 21 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time from CoV-SCAN positive to PCR positive result	To compare time to diagnosis with the rapid antigen testing regimen to the gold standard PCR testing regimen	Baseline to 21 days

Collaborators and Investigators

• Sponsor: Columbia University
• Investigators: Principal Investigator: Kathrine Meyers, DrPH, MS, MPP, Assistant professor

Study record dates

Study Major Dates

• Study Start (Actual): February 19, 2021
• Primary Completion (Actual): June 2, 2021
• Study Completion (Actual): July 14, 2021

Study Registration Dates

• First Submitted: March 17, 2021
• First Submitted That Met QC Criteria: March 17, 2021
• First Posted (Actual): March 18, 2021

Study Record Updates

• Last Update Posted (Actual): November 18, 2021
• Last Update Submitted That Met QC Criteria: November 11, 2021
• Last Verified: November 1, 2021

More Information

Terms related to this study

• Keywords: SARS-CoV-2; Coronavirus; COVID-19; COVID
• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19
• Other Study ID Numbers: AAAT5233

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No