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Rapid Antigen Test Request Process

About BinaxNOW™ COVID-19 Test

The BinaxNOW™ COVID-19 test is a lateral flow test that detects the presence of protein antigens from SARS-CoV-2 in individuals suspected of COVID-19 by their healthcare provider within the first seven days of symptom onset. This U.S. Food and Drug Administration (FDA)-authorized diagnostic test does not require any instrumentation to test the samples and instead determines a COVID-19 negative or positive result in about 15 minutes using a test card.

Distribution of Rapid Antigen Test in Suburban Cook County

The U.S. Department of Health and Human Services (HHS), in partnership with the Department of Defense (DOD), is providing rapid point-of-care tests (BinaxNOW™ COVID-19 test) to the Illinois Department of Public Health who will be distributing tests to local health departments, including the Cook County Department of Public Health (CCDPH), as well as directly to designated sites in suburban Cook County.

CCDPH will be distributing the rapid point-of-care tests (BinaxNOW™ COVID-19 test) to organizations for use in suburban Cook County. CCDPH will be prioritizing distribution of rapid point-of-care tests (BinaxNOW™ COVID-19 test) to vulnerable and high-risk populations based on COVID-19 surveillance data for suburban Cook County, CCDPH’s COVID-19 Community Vulnerability Index, and State and Federal guidance. This includes congregate settings like long-term care facilities and schools and areas known to have a lower capacity for testing.

Rapid Antigen Test Program Requirements

Organizations must meet the below requirements prior to submitting a request to CCDPH:

  1. Testing Fees – While entities can charge for the service of delivering the test, no entity can charge for the BinaxNOW test supplies themselves. No distribution of BinaxNOW tests may result in the consumer being charged directly for COVID-19 testing above and beyond what their insurance will cover.
  2. Provider Order – All tests must be performed under the direction of a health care provider’s order. These orders can be issued by health care providers on an individual basis, or health care providers or CCDPH can issue standing orders (Email standing order requests to CCDPH)
  3. Qualified Healthcare Professional – Tests must be performed by a qualified healthcare professional, which includes physicians, nurses, medical assistants, pharmacists, etc. (Non-Clinical Sites must name a Clinical Partner unless you are a school with a school nurse.)
  4. Parental Consent if Testing Minors – Any entity testing minors must be prepared to obtain proper parental consent.
  5. CLIA Certificate of Waiver – This test is authorized by FDA to be run in sites with a CLIA Certificate of Waiver, Certificate of Compliance, or Certificate of Accreditation. Under CLIA rules, persons who perform POC tests must be appropriately trained to perform the test and must use appropriate PPE when handling samples.
    • Please do not submit your application until you have your CLIA waiver.
    • More information on how to obtain a CLIA waiver can be found here.
    • CLIA Waiver application can be found here.
    • Submit CLIA Application and Questions to Illinois Department of Public Health.
    • If you need assistance obtaining a CLIA waiver, please contact CCDPH.
  6. Reporting Use – Sites who receive these tests must report data for all testing completed, for each individual tested. This data must be reported within 24 hours of test completion, on a daily basis, to IDPH. Register in IDPH’s reporting system with the entities’ CLIA certificate number.
    • You will need your CLIA number, ordering provider, entity name, address, phone number, the type of testing platform, and the point of contact email and phone number.
    • Once the registration has been processed, the individual who submitted the registration will receive an email with a link to begin reporting. This link is unique to the entity and can be shared with other staff who will be reporting results.
    • Each positive and negative test result must be reported to the IDPH system within 24 hours.
    • Entities must report all positive test results to their local health department (LHD).
  7. Training. Staff that will be administering the rapid antigen tests (BinaxNOW™ COVID-19 test) must complete the required trainings: BinaxNow COVID-19 Ag Card and Navica App Setup and Training  and  IDHP BinaxNow COVID-19 Antigen Training
  8. COVID-19 Education – Educate all testing recipients on CDC Guidance on What to Do if You are Sick.

Organizations can refer to the following links for more information about these requirements:

  1. Abbot BinaxNow COVID-19 Diagnostic Testing Fact Sheet
  2. IDPH Rapid Point-of-Care Testing for COVID-19 in Community Settings and Schools
  3. BinaxNow COVID-19 Ag Card and Navica App Setup and Training
  4. IDHP BinaxNow COVID-19 Antigen Training

COVID-19 Rapid Antigen Test Request Form

Organizations in suburban Cook County who are currently testing or have the capacity to use rapid antigen testing for COVID-19 are encouraged to request rapid point-of-care tests (BinaxNOW™ COVID-19 test) using the CCDPH COVID-19 Rapid Antigen Test Request Form.

Organizations should submit 1 application per site (e.g.1 application per school, 1 application per hospital, etc.). Organizations can submit test kit requests, as needed, but no more than one time per week. Currently, the maximum amount an organization can request per site is 1,000 tests (or 25 test kits) per week. Please note that organizations may not get the requested amount of test kits. The amount of test kits allocated is subject to available resources and CCDPH’s resource prioritization process. Recipients are currently expected to pick up their supply from a location in Oak Forest. If this is not possible, please contact CCDPH. Applications are only accepted for sites in suburban Cook County. Sites in the city of Chicago and sites in suburban Cook County areas with their own state-certified health department (Evanston, Oak Park, and Stickney Township) should submit to their respective health department. CCDPH will follow up with organizations about their request for COVID-19 Rapid Antigen Tests within 3-5 business days.

COVID-19 Rapid Antigen Test Materials Provided Per Kit

  • Test Cards (40): A cardboard, book-shaped hinged test card containing the test strip
  • Extraction Reagent (1): Bottle containing 10 mL of extraction reagent
  • Nasal Swabs (40): Sterile swabs for use with BinaxNOW COVID-19 Ag Card test
  • Positive Control Swab (1): Non-infectious recombinant SARS-CoV-2 nucleocapsid antigen dried onto a swab
  • Negative Control Swab: The use of a sterile patient swab ensures appropriate negative results are obtained
  • Product Insert (1)
  • Procedure Card (1)

 

 

 

Available Training Resources on COVID-19 Rapid Antigen Test

Below are training resources for use of COVID-19 Rapid Antigen Test:

  1. BinaxNow™ COVID-19 AG card and NAVICA™ app set-up and training
  2. Illinois Department of Public Health BinaxNow™ COVID-19 Antigen training

If you have any questions, please call: 708-836-4755 or email: [email protected]

Updated 11/6/2020

Resources

Cook County Resources

Cook County ShinyApp

IDPH

CDC