NCT04805840

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

• Status: Terminated
• Phase: —
• Study type: Observational
• Enrollment: 93 (actual)
• Sponsor: Columbia University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

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.

Conditions

• Covid19

Interventions

Type	Name	Description
DEVICE	CoV-SCAN rapid COVID-19 antigen test	SARS-CoV-2 rapid antigen screening test

Timeline

• Start date: 2021-02-19
• Primary completion: 2021-06-02
• Completion: 2021-07-14
• First posted: 2021-03-18
• Last updated: 2021-11-18

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study