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Antigen Testing For EMS Agencies

The Southwest Virginia EMS Council maintains a CLIA laboratory waive to allow for Antigen Testing by EMS agencies in our region.  We maintain a stockpile of Abbott BinaxNOW COVID-19 Antigen Cards for this purpose.  Licensed EMS agencies located in the LENOWISCO, Cumberland Plateau, or Mount Rogers health districts may, if completing necessary requirements, participate in an antigen testing program utilizing our regional CLIA waiver.

Program Participation

EMS agencies wishing to participate must work with their Operational Medical Director (OMD) to develop a testing plan and protocol and submit required documentation. Working under the Council’s CLIA waiver, an Operational Medical Director (OMD)/EMS Physician serves as the “prescriber” identified in the Code of Virginia, and as the supervising physician for the EMS providers administering tests. The OMD is ultimately responsible for the supervision of the testing program. In addition, the OMD must ensure they approve each provider who will administer tests has received training in the necessary areas. These include handling of the test, specific testing protocols, and reading and recording of test administration and test results.

  • The OMD/Agency will keep a written record of those providers approved to administer tests: an example is provided in Appendix A.
  • The OMD must report test results to the appropriate individuals, including, but not limited to, the local health district.
  • A record of tests administered and the results of those tests must be maintained by the Agency
  • Ensure reporting of test results as required by the Local Health District

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 the Southwest Virginia EMS Council, Inc.  Upon receipt of this documentation, EMS agencies may request BiNax Antigen Testing Kits from the Council by emailing our office at . Include your agency name, contact information, and the number of kits needed.

Frequently Asked Questions:

Does this test tell me if I have already had COVID?

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.

How does the test work?

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.

When should someone be tested?

It is recommended that test should be performed within the following timer periods:

  • IF ASYMPTOMATIC: 5-8 days from exposure
  • IF SYMPTOMATIC: 7 days or less from exposure

Is this test for EMS patients?

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

 

Does my agency need a CLIA Certificate of Waiver?

No, if your agency is based in one of the health districts outlined above, the Southwest Virginia EMS Council carries a regional CLIA waiver and it has been updated to include the Abbott BinaxNOW COVID-19 Antigen Cards.

 

What are the Follow-Up Testing Procedures?

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

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

How do I report my agency’s test results?

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:

Can providers self-collect?

The following link provides information on the procedure for self-collection.

https://www.fda.gov/medical-devices/letters-health-care-providers/recommendations-providing-clear-instructions-patients-who-self-collect-anterior-nares-nasal-sample?utm_medium=email&utm_source=govdelivery

What is the minimum training for antigen testing?

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.

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