Regional Abbott BinaxNOW COVID-19 Antigen Cards Distribution

Documents & Submissions

Clinical performance characteristics of BinaxNOW™ COVID-19 Ag Card, including specificity and sensitivity, can be found starting on page 9.


Overview:

The U.S. Department of Health and Human Services (HHS) provided VDH Local Health Districts (LHDs) 100,000 BinaxNOW tests in late November to address their immediate community needs. Based on the expected receipt of additional BinaxNOW test kits from HHS, VDH Central Office will send LHDs a second supply of tests in late December. This shipment will be approximately 1-3 times the initial shipment sent.

Other partnerships that the testing team is actively working on as of December 1 include:

  • Distribution to a Retail Pharmacy, TBA (15 locations) (90,000)
  • Statewide EMS Councils (Varied amounts, 1500 or less)
  • Additional shipment to Free Clinics (~5,000 tests)

The state will retain approximately 10% of its existing supplies to help support emergent needs or outbreak response.

To access the VDH’s clinical and public health recommendations on use of antigen tests including the BinaxNOW, please see the Antigen Testing Recommendations. For any questions, please contact antigeninfo@vdh.virginia.gov.

The Regional Council Process

In late December 2020, Old Dominion EMS Alliance (ODEMSA) will receive a shipment of Abbott BinaxNOW COVID-19 Antigen Cards. These antibody tests will then be distributed throughout the region.

Allocation Methodology

Following the notice that that antigen tests would need to be distributed, ODEMSA devised a method of initial distribution based upon the number of tests promised and the number of providers primarily affiliated with each agency based out of health planning districts 13, 14, 15, and 19. Using the fractional number for each agency the number of tests were divided up to each agency evenly.

Opt-In Period

On December 17, 2020, following the first ODEMSA Regional COVID-19 Information Meeting, documents were sent to all parties that registered as attending said meeting.

Each agency has until December 31, 2020, to have their agency Operational Medical Director (OMD) review and comply with the steps needed to administer tests to patients in accordance with the laws and regulations of the Commonwealth of Virginia.

Once all requirements have been met to comply with regulations and training has been completed, the agency OMD (or their authorized agent) must submit “Appendix A” found on page 5 of the OEMS Antigen Testing Process. This document must be completed and signed by the OMD and all participants before submission to ODEMSA.

Agencies that choose not to participate or are unable to complete the needed steps by the deadline listed above, shall forfeit their guaranteed allocation of test kits, which shall be returned to the ODEMSA test kit pool.

Deferred Opt-In Period

Agencies that are unable to complete the needed steps before the deadline may still receive antigen test kits from ODEMSA. Agencies must complete the same steps and meet the same requirements as listed in the OEMS Antigen Testing Process document.

Distribution

In early January 2021, agencies that completed the needed steps and have been approved to distribution will receive their allocation of test kits. They will be distributed in one of three ways:

  1. By scheduled pickup at the ODEMSA Executive Office
  2. At locations and times across the region that will be scheduled based upon the needs of agencies
  3. By prepaid delivery by the agency’s courier of choice (i.e. USPS, UPS, FedEx, etc.)

For questions about Antigen Test Distribution please call 804.560.3300 extension 104 or email: rscarbrough@vaems.org.

No, if your agency is based in health planning districts 13, 14, 15, and 19. ODEMSA carries a regional CLIA waiver and it has been updated to include the Abbott BinaxNOW COVID-19 Antigen Cards.

Maybe, if your agency is based in another portion of the state outside of the ODEMSA health planning districts, you will need to check with your regional council. Your agency’s regional council is dependent upon the address on file with OEMS for the agency license.

The following link provides additional information for follow-up testing procedures.

https://www.cdc.gov/coronavirus/2019-ncov/lab/resources/antigen-tests-guidelines.html

Appropriate reporting of results is required for anyone participating in antigen testing. The below links provide access to resources for reporting results. Agencies should work with their Local Health District to ensure they develop an adequate and appropriate reporting process.

If instructed by the Local Health District, please create an account in advance of testing as it can take 2-3 day to be granted access to the reporting portal:

https://www.vdh.virginia.gov/clinicians/covid-19-update-for-virginia-7/

https://apps.vdh.virginia.gov/pocreporting/login/login.aspx

The links on the below page (located about halfway down the page) must be completed by EMS providers (EMT-I and EMT-P) interested in conducting Antigen Testing.

https://www.globalpointofcare.abbott/en/support/product-installation-training/navica-brand/navica-binaxnow-ag-training.html

No. The Abbott BinaxNOW COVID-19 Antigen Card is for testing for antigen proteins to determine if a person is actively infected. If you believe that you have already had COVID you can take an Antibody test which will screen for the antibodies found after being infected.

The BinaxNOWTM COVID-19 Ag Card is a lateral flow immunoassay intended for the qualitative detection of nucleocapsid protein antigen from SARS-CoV-2 in direct anterior nasal (nares) swabs from individuals suspected of COVID-19 by their healthcare provider within the first seven days of symptom onset. Testing is limited to laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, that meet the requirements to perform moderate, high or waived complexity tests. This test is authorized for use at the Point of Care (POC), i.e., in patient care settings operating under a CLIA Certificate of Waiver, Certificate of Compliance, or Certificate of Accreditation.

To perform the test, a nasal swab specimen is collected from the patient, 6 drops of extraction reagent from a dropper bottle are added to the top hole of the swab well. The patient sample is inserted into the test card through the bottom hole of the swab well, and firmly pushed upwards until the swab tip is visible through the top hole. The swab is rotated 3 times clockwise and the card is closed, bringing the extracted sample into contact with the test strip. Test results are interpreted visually at 15 minutes based on the presence or absence of visually detectable pink/purple colored lines. Results should not be read after 30 minutes.

For more information please visit the FDA website:

https://www.fda.gov/media/141570/download#:~:text=To%20perform%20the%20test%2C,read%20after%2030%20minutes.

It is recommended that test should be performed within seven days of the onset of symptoms.

No, the tests allocated through the regional EMS council are intended to be used as a screening tool for agencies and their providers.

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