Get Started
Is your district interested in rapid antigen testing?
Contact our Training Strategist team to learn more about rapid antigen testing in California school districts.
How to get Started?
Identify a Testing Coordinator or “BinaxNOW Lead” in your School District, who will serve as the key liaison between CDPH and your school for updates on new testing guidelines and procedures. The Testing Coordinator can be anyone from your Principal, Superintendent, District Nurse, or a new hire.
Next Steps
- Submit CDPH Interest Form here
- Attend one-hour FAQ Meeting with CDPH
- Identify on-site Testing Staff
- Sign Memorandum of Understanding (MOU)
- Order Test Kits (due to an increase demand, expect delays in shipping and submit order as soon as possible).
- Sign up and attend (once test kits are received) the CDPH one-hour Virtual Training on performing the test (Monday - Friday 10am Registration Link, 3pm Registration Link or Monday/Wednesday, 5pm Registration Link)
- Complete CDPH Competency Quiz online (link provided following training).
- Attend Primary.Health Software Training for recording results, available Monday, Wednesday and Friday at 1pm. Register here.
Key Objectives
- Aim for 90% Consent Rate from families and staff (Ask about our best practices).
- Strategize on creating an operational plan for maximal screening and minimal class time disruption (SOS can support).
- Follow guidelines and regulations from your Local Health Department on COVID-19 response.
- Promote vaccination and routine testing for all unvaccinated students and staff.
- Continue use of masks for both vaccinated and unvaccinated persons while indoors.
Ongoing Support
The integration of testing in schools is new for many, Safely Opening Schools staff is available for ongoing support and sharing best practices learned from the SOS pilot.
You can learn from your peers by attending the Bi-Weekly CDPH Discussion Groups (invitation forthcoming upon completion of program enrollment.
If you have any questions regarding program implementation or need support with enrolling in the CDPH testing program, please contact [email protected].
Rapid Testing Videos
Please visit our YouTube Channel to view rapid testing promotional videos for parents/families.
CLIA Waivers for other Sites
To use rapid antigen tests in many settings you will need a Clinical Laboratory Improvement Amendment (CLIA) Waiver. A CLIA waiver allows you to carry out a low complexity test like Abbott’s BinaxNOW rapid antigen test outside of the traditional clinical laboratory setting but with some professional oversight. This is required by the FDA for use of most rapid antigen tests. The waiver process varies from state to state. The California Department of Public Health is offering an umbrella CLIA waiver for other types of facilities such as Homeless Shelters or Daycare Centers, see the Testing Taskforce website for more information. Locations can also apply for their own CLIA waiver, however, we recommend using the state’s CLIA if you are are eligible.
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To apply for your own waiver, you will need to follow the steps below:
- Identify a physician or clinical laboratory director who will act as your CLIA Director.
- Complete and submit the paperwork. Forms are all available on the CDPH website here. They are submitted as uploaded attachments to the online application. You will need:
- The new online waiver application
- The Federal CMS 116 completed by the CLIA Director
- The state LAB 183 form an attestation completed by the CLIA Director and the
- The state LAB182 attestation completed by the organization that will be testing.
- A full list of the sites where you plan to do the testing
- Pay the fees
- The state fee to submit the CLIA application is $113 payable plus $26 per testing site payable to CDPH at the time of application.
- The Federal fee is approximately $150 and will be invoiced later.
- Note: The site can start testing once the waiver request is submitted!
- Issue a standing order for testing: Have your CLIA Director or another physician issue a standing order for testing with the selected test at your institution. See an example here.
Training
SOS participants complete comprehensive on-site and virtual training.
Who can be trained?
Trainees do not need to be health professionals to implement this test. The California Department of Public Health has determined that school personnel “who are caring for students under their responsibility” are authorized to carry out this test. However, school nurses or other health professionals provide valuable oversight and are encouraged to participate.
Use our Rise Online-Training Platform
Rise is an online training platform that outlines the CDPH Playbook, as well as a series of simple and accessible lessons for people who are being trained to implement rapid testing. Rise can also allow a site administrator track who has completed their training. Contact [email protected] to get access on the Rise Platform.
Video Trainings Available Online
- Abbot BinaxNOW Training modules 1 – 4 (11 minutes)
- Training for reading equivocal tests for all participants who will be reading or registering test results (8 minutes)
- HIPAA training (15 minutes) – only for those without certification for screening and test administrators who do not have a HIPAA certificate, you can receive one online after going through the online training course. There are a number of resources for HIPAA Training, for example this training with Accountable.
- Donning PPE (4 minutes)
- Doffing PPE (4 minutes)
Other key training materials
- California Department of Public Health K-12 School Rapid Testing Program’s Playbook. This is a comprehensive guide to most information for rapid antigen testing. It walks the reader through all key information on what is needed for a testing program. This guide is most useful for school district or school screening program coordinators overseeing the entire process
- Training Powerpoint: covers basic issues on the test, roles in the screening process, test interpretation and use of PCR. Some information is specific to the Primary data platform.
- Primary Learning Guide: covers basic steps for using the Primary data platform
- Material for laminated cards for tabletop use
- Guide to reading BinaxNOW tests
- Self-Swab instructions
- Test time calculator
- Algorithm for when follow-up PCR is needed
- AbbottBinaxNOW Notice of Extension of expiration dates for test kit lots
- Quality Control Log for BinaxNOW testing. Sites are required to perform the quality control tests once for each new shipment or lot received (not each box). Results should be logged.
- Training Log: sites should keep careful records of training of staff implementing rapid antigen testing.
Data Platforms
A data platform is essential to support large scale screening. Key functions for a data platform, include:
- Registering students, staff and teachers
- Collecting consent from staff and parents
- Scheduling tests if needed
- Providing appropriate language options for your community
- Recording test results linked to the individuals tested
- Carrying out mandatory public health reporting
- Notifying individuals or their parents of results
- Providing the district with a useful dashboard with which to understand findings and manage the process
- Connecting to PCR providers who can also carry out insurance billing
We are aware of these platforms:
- Primary.Health which is the SOS partner.
- Project Beacon which was created for Massachusetts and is being used in other states
- Abbott is offering the Navica App which is free but has fewer functions.
In general platforms require an onboarding fee and a per test processing fee based on testing volume.
Other Resources
California recommendations
- State of California Safe Schools for All Plan
- California Department of Education chart outlines sources of funding that can cover COVID-19 testing activities including rapid antigen testing.
National reports
- CDC school guidance
- Rockefeller Foundation’s Taking Back Control: A Resetting of America’s Response to COVID-19
- FDA list of approved diagnostics for COVID-19
Scientific articles
- Read about the science of BinaxNOW. For purposes of preventing transmission in schools, the most relevant comparison is looking at the sensitivity and specificity in relation to PCR tests. These indicate tests with a high level of the virus and the likelihood that the individual tested is infectious.
- Read about a strategy for containment in Rethinking Covid-19 Test Sensitivity (Harvard)
- Read about field performance and public health response using BinaxNOW (UCSF)
- Read about performance characteristics of rapid antigen detection at a public plaza testing site in San Francisco (UCSF)
- Read this evaluation of Abbott BinaxNOW Rapid Antigen Test at two community-based testing sites in Pima County, Arizona (CDC)
- Read about the analytical sensitivity of the Abbott BinaxNOW card (University of Washington)
- Learn more about the performance characteristics of BinaxNOW in this report about Screening Asymptomatic Individuals in a University Setting (University of Utah)
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Safely Opening Schools is a project of the Public Health Institute, (PHI) PHI has been a leader in public health and development for over 50 years. PHI is a 501(c)(3) non-profit organization with a vision of creating healthy communities where individuals reach their highest potential. Safely Opening Schools is part of PHIs Prevention Policy Group, which works on policy approaches involved in safely opening public schools after Covid-19.
