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

Sponsor
Columbia University (Other)
Overall Status
Terminated
CT.gov ID
NCT04805840
Collaborator
(none)
93
Enrollment
1
Location
4.8
Actual Duration (Months)
19.5
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or DiseaseIntervention/TreatmentPhase
  • 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 Design

Study Type:
Observational
Actual Enrollment :
93 participants
Observational Model:
Ecologic or Community
Time Perspective:
Prospective
Official Title:
Comparison of Screening for SARS-CoV-2 (COVID-19) in a Low Prevalence Setting Using Serial Antigen Testing Versus Serial Molecular (PCR) Testing
Actual Study Start Date :
Feb 19, 2021
Actual Primary Completion Date :
Jun 2, 2021
Actual Study Completion Date :
Jul 14, 2021

Outcome Measures

Primary Outcome Measures

  1. Sensitivity of CoV-SCAN daily testing regimen [Baseline to 21 days]

    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

  2. Specificity of CoV-SCAN daily testing regimen [Baseline to 21 days]

    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

Secondary Outcome Measures

  1. Time from CoV-SCAN positive to PCR positive result [Baseline to 21 days]

    To compare time to diagnosis with the rapid antigen testing regimen to the gold standard PCR testing regimen

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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.

Contacts and Locations

Locations

SiteCityStateCountryPostal Code
1Columbia University Irving Medical CenterNew YorkNew YorkUnited States10032

Sponsors and Collaborators

  • Columbia University

Investigators

  • Principal Investigator: Kathrine Meyers, DrPH, MS, MPP, Assistant Professor

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Columbia University
ClinicalTrials.gov Identifier:
NCT04805840
Other Study ID Numbers:
  • AAAT5233
First Posted:
Mar 18, 2021
Last Update Posted:
Nov 18, 2021
Last Verified:
Nov 1, 2021
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
Keywords provided by Columbia University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Nov 18, 2021