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Overview - Rapid Antigen

  • Updated

To get started, take a look at the steps required to set up for your First Test Day. 

 

NOTE: This article (and other supporting articles on rapid antigen testing) is not intended to replace FDA guidance. Test Supervisors should perform all testing according to the FDA-authorized Instructions for Use and any other authorized labeling provided with the test kits.

 

A. Sign up 

  1. Tell us how many people you plan to test and how many school sites you have.
  2. Create a testing plan which includes the first test day and frequency of testing.
  3. Share your testing plan with us at least 10 days in advance and we’ll ensure you have the necessary testing materials prior to test day. 

B. Onboard

  1. Gather consents from parents/ guardians and staff, either digitally or through our paper consent process.
  2. Add team members to support with registering tests and test day set-up. You will need to add at least one Test Supervisor to your team in order to conduct testing (if you have staffing support from Concentric, you should add your assigned staff person as a Test Supervisor). If a Test Supervisor will enter results from Rapid Antigen, please ensure their account is enabled with this feature*. It is required that these individuals review the Instructions For Use and perform all necessary steps to become a trained operator prior to conducting any tests.
  3. Review materials and watch the Rapid Antigen Testing Onboarding & Training Videos.
  4. Receive test materials and set up for testing day.

C. Test

  1. Test Taker checks in; test kit is registered and assigned to a Test Taker BEFORE collecting the sample. 
  2. Run the test per the IFU. Be sure to follow each tests’ Instructions for Use to determine when to interpret test results. 
    • BinaxNOW™ COVID-19 Ag Card (IFU LINK) - Test cannot be interpreted any earlier than 15 minutes and no later than 30 minutes after starting the test.
    • CareStart COVID-19 Antigen test (IFU LINK) - Test cannot be interpreted any earlier than 10 minutes and no later than 15 minutes after starting the test.
    • GenBody COVID-19 Ag Card (IFU LINK) - Test cannot be interpreted any earlier than 15 minutes and no later than 20 minutes after starting the test.

D. Results

  1. The result is read, interpreted, and recorded in the portal within the appropriate time frame as indicated per the IFU.
  2. Should there be a positive test result, the Test Taker is identified  by the Test Supervisor and the Test Champion determines next steps to prevent or mitigate outbreaks. 

*For clients using medical support, please note that they will support with registering test tubes, swab collection (as needed), and reading & interpreting results. 

 

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