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COVID-19 Rapid Antigen Test Request Process
About the BinaxNOW™ and iHealth™ COVID-19 Tests
The BinaxNOW™ and iHealth™ COVID-19 tests are lateral flow tests that detect the presence of protein antigens from SARS-CoV-2 in individuals suspected of COVID-19 within the first seven days of symptom onset. These U.S. Food and Drug Administration (FDA)-authorized diagnostic tests do not require any instrumentation to test the samples and instead determine a COVID-19 negative or positive result in about 15 minutes using a test card.
Distribution of Rapid Antigen Tests: St. Clair 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™ and iHealth™ COVID-19 tests) to the Illinois Department of Public Health who is distributing tests to local health departments, including the St Clair County Health Department. SCCHD is distributing the rapid point-of-care tests (BinaxNOW™ and iHealth™ COVID-19 tests) to organizations for use in St Clair County. SCCHD is prioritizing distribution of rapid point-of-care tests to vulnerable and high-risk populations based on COVID-19 surveillance data for St Clair County, SCCHD’s COVID-19 Community Vulnerability Index, and State and Federal guidance. This includes congregate settings (e.g., long-term care facilities and shelters), schools, and areas with a lower testing capacity. SCCHD no longer distributes these tests to private organizations per the direction of the Illinois Dept of Public Health (IDPH).
- Schools are eligible for free SHIELD and BinaxNOW tests. Email DPH.COVIDSchool@illinois.gov or SHIELD signup via emailing Beth Heller, Senior Director of External Affairs for SHIELD, at bheller@uillinois.edu
- Long term care facilities can email Binax.Team@hhs.gov and request to be added to the direct distribution list.
- Federally Qualified Health Centers (FQHCs) that receive operational funding through HRSA’s Health Center Program are eligible for direct shipments. Eligible FQHCs should be able to request a supply of Quidel tests by following the instructions provided by HRSA. This is the same process and online platform that is used to request vaccines.
- Hospitals and First Responders should request tests directly from IDPH by emailing dph.antigentesting@illinois.gov
The Midwest Coordination Center (MCC) is another testing resource for schools, nursing homes, shelters, and child/youth care centers: https://testedandprotected.org
Any camp that serves K-12 aged children, even if not associated with a school, is eligible to receive free COVID-19 antigen tests. These tests are made available to camps in all States. To place Summer Camp orders for free COVID-19 antigen tests, email the Camp information and tests requested to DPH.AntigenTesting@illinois.gov
Organizations must meet the below requirements prior to submitting a request to SCCHD:
- TestingFees – While entities can charge for the service of delivering the test, no entity can charge for the BinaxNOW or iHealth test supplies themselves. No distribution of BinaxNOW or iHealth tests may result in the consumer being charged directly for COVID-19 testing above and beyond what their insurance will cover.
- Provider Order – All tests must be performed under the direction of a health care provider’s order.
- Trained Staff – Tests must be performed by individuals who complete the required BinaxNOW and iHealth training, including eligible nurses, medical assistants, other healthcare professionals, and other school staff. This is an update as of 9/7/2021, as previously only healthcare professionals were allowed to administer tests.
- Parental Consent if Testing Minors – Any entity testing minors must be prepared to obtain proper parental consent.
- 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 and CLIA application can be found here.
- Submit CLIA Application and Questions to Illinois Department of Public Health.
- If you need help, here is the CMS CLIA Quick Start Guide
- 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 or through SimpleReport 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).
- Training – Staff that will be administering the rapid antigen tests (BinaxNOW™ and iHealth™ COVID-19 tests) must complete a training.
- COVID-19 Education – Educate all testing recipients on CDC Guidance on What to Do if You are Sick.
Organizations in St Clair 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™ and iHealth™ COVID-19 tests) using the SCCHD COVID-19 Rapid Antigen Test Request Form.
Organizations should submit one application per site (e.g.one application per school, one application per hospital, etc.).
Please submit test requests as needed, but no more than one time 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 SCCHD’s resource prioritization process.
BinaxNOW 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)
iHealth Materials Provided Per Kit:
- COVID-19 Test Card(s) (2 ea/box)
- Nasal Swab(s) (2 ea/box)
- Tube(s) (2 ea/box)
- Lay User Instruction for Use (1 ea/box)
Below are training resources for use of COVID-19 Rapid Antigen Test: