Please find following an urgent announcement from the Virginia Department of Health (VDH) about the availability of a significant supply of COVID-19 rapid antigen tests.   These tests are provided at no cost by the government and are not eligible for reimbursement.  Please direct all questions to the VDH (see contact information in this notice).

 

The purpose of this notice is to inform providers about point-of-care (POC) COVID-19 antigen tests that the Virginia Department of Health has and would like to distribute quickly to medical providers throughout the state.  The U.S. Department of Health and Human Services (HHS) sent Abbott BinaxNOWTM COVID-19 Antigen (Ag) Cards at no cost to the Commonwealth, and also directly to long-term care facilities, assisted-living facilities and other organizations.  VDH, in turn, has distributed many Abbott BinaxNOW COVID-19 Antigen Cards to organizations throughout Virginia. 

 

This notice addresses:

 

  • Abbott’s extension of critical expiration dates for rapid antigen tests

 

  • Becton Dickinson (BD) Veritor Rapid COVID-19 Antigen test devices – Devices expire between April 1 and early May

 

  • Requirements and other information 
    • Clinical Laboratory Improvement Amendments (CLIA)
    • Training
    • Prescriptive authority
    • Ordering antigen tests
    • Reporting antigen test results to VDH
    • Additional comments

 

  • Contact for questions

 

Abbott’s extension of critical expiration dates for rapid antigen tests


The Commonwealth continues to have a supply of drug maker Abbott’s BinaxNOW COVID-19 Ag cards on hand which were originally set to expire in mid-April 2021.
  Abbott has continued product testing for product stability to extend the expiration date of its product to support a shelf-life (expiration date) of up to nine months.  The drug maker shared these results with the Food and Drug Administration (FDA).  With the product’s extension, the BinaxNOW COVID-19 Ag Card product that providers may have in their possession may now have a longer than labeled product expiration date.  For Abbott’s product expiration update along with a listing of BinaxNOW COVID-19 Ag Card lots impacted by the extension, we urge providers to visit the Virginia Department of Health’s website at: https://www.vdh.virginia.gov/content/uploads/sites/8/2021/03/120008145-v1-BinaxNOW-COVID-19-Product-Expiry-Extension-March-2021.pdf

 

Becton Dickinson (BD) Veritor Rapid COVID-19 Antigen test devices – Devices expire between April 1 and early May


In addition, VDH has a supply of Becton Dickinson (BD) Veritor Rapid COVID-19 Antigen test devices and analyzer machines available for distribution to medical providers in the state at no cost.  The Becton Dickinson test devices have an expiration date between April 1 and early May 2021.  Both the Abbott BinaxNOW COVID-19 Ag Cards and BD Veritor Rapid Antigen tests are prescription only items.

 

Requirements and other information

In order to use either the Abbott BinaxNOW COVID-19 Antigen Cards or the BD Veritor Rapid Antigen test system, the following items must be completed by the test provider:

 

  1. The facility, medical practice, etc., where the test will be performed needs a current Clinical Laboratory Improvement Amendments (CLIA) Certificate of Waiver, CLIA Certificate of Compliance, or a CLIA Certificate of Accreditation.  Both the BinaxNOW Antigen Card and BD Veritor tests are CLIA-waived. A CLIA certificate must be obtained before BinaxNOW or BD Veritor supplies can be shipped to the receiving facility.  If a practice doesn’t have a current CLIA certificate, a CMS-116 form needs to be competed. This form can be found online at https://www.cms.gov/Medicare/CMS-Forms/CMS-Forms/Downloads/CMS116.pdf.  Once completed, the form requires an original signature, so it will need to be mailed to:

 

Virginia Department of Health

Office of Licensure and Certification

9960 Mayland Drive, Suite 401

Richmond, Virginia 23233

 

For medical practices, facilities, etc., that already have a current CLIA certificate, another one is NOT needed.  Please email the VDH Office of Licensure and Certification at CLIALAB@vdh.virginia.gov and inform them you will be doing POC COVID-19 antigen testing and indicate the test you are using.

 

  1. Training to use either the Abbott BInaxNOW COVID-19 Antigen Card or the BD Veritor system must be completed.  Both companies offer online training. Abbott BinaxNOW training can be found at https://www.globalpointofcare.abbott/en/support/product-installation-training/navica-brand/navica-binaxnow-ag-training.html. Abbott also offers a webinar led by a company representative.  BD Veritor training is located at www.bdveritor.com/training/. The BD training site offers a certificate of completion for the user.  We recommend that people using the BD Veritor system complete this program and obtain the certificate.  Regardless of whether an individual completes the Abbott or BD training, we also recommend that a written record be maintained of all training courses completed.  We recommend the employer and employee keep a copy of this record.

 

  1. Prescriptive authority. Both the Abbott BinaxNOW Ag Card and BD Veritor tests are prescription only items. In order for persons to be tested, they must have an order from a medical provider with prescriptive authority.  This professional does not need to be a physician— he or she can be another provider with prescriptive authority such as a nurse practitioner, physicians’ assistant, etc.  Another option is for a prescriber to write a standing order for the practice, facility, etc.  The standing order should specify what groups of people it applies to, and who will perform the actual antigen test.  For example, a standing order might state that any patients with symptoms consistent with COVID-19 should be offered antigen testing that will be performed by certain trained staff at the practice, facility, etc.  The standing order can be customized according to the needs of the practice.  A signed, dated hard copy of the order should be kept at each location where the standing order will be used.

 

  1. Ordering antigen tests. To order BinaxNOW COVID-19 Ag Cards or BD Veritor tests, please email Brooke Rossheim, MD, MPH (Public Health Physician Specialist, VDH COVID-19 Testing Team) at Brooke.Rossheim@vdh.virginia.gov. Abbott BinaxNOW Ag Cards come in boxes of 40 tests and BD Veritor tests come in boxes of 30.  Our suggestion is that one medical provider order 120 tests at a time.  If a practice has multiple providers, please adjust the order accordingly.  VDH has an ample supply of tests on hand, so the provider or practice should order what is needed.

 

  1. Reporting antigen test results to VDH. Once antigen testing has started, all test results (both positive and negative) must be reported within 24 hours to VDH through an online test result portal located at: https://apps.vdh.virginia.gov/pocreporting/login/login.aspx.

 

  1. Additional comments. Please note that VDH does not have a mechanism in place to transfer cards from a practice, facility, etc., back to VDH, or to another medical provider. Please keep this in mind when ordering tests.  If a practice or facility has too many tests, please keep them and use to the extent you are able.  

 

Contact for questions

 

For clinical questions regarding antigen testing, please contact Dr. Brooke Rossheim by email at Brooke.Rossheim@vdh.virginia.gov.  For logistical questions about antigen testing, please email your question(s) to antigeninfo@vdh.virginia.gov.

 

In closing, thank you for your interest in COVID-19 antigen testing using the Abbott BinaxNOW or BD Veritor platforms.  We look forward to working with you and providing antigen tests to benefit both you and your patients.  On a broader level, we want to thank you for your continued dedication and hard work during the COVID-19 pandemic.  This has been and continues to be a very challenging time for everyone in healthcare.  At VDH, we are very appreciative of your work in supporting the healthcare needs of all people in Virginia.

 

Contact:

Brooke Rossheim, MD, MPH

Public Health Physician Specialist

COVID-19 Testing Team

Virginia Department of Health

247-0321-EM-VA



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