Q: Does my agency need a CLIA Certificate of Waiver?

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.

Question 1

How do I report my agency's test results?

Accepted Answer

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

Question 2

Can providers self-collect?

Accepted Answer

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

Question 3

What is the minimum training for antigen testing?

Accepted Answer

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

Question 4

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

Accepted Answer

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.

Question 5

How does the test work?

Accepted Answer

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.

Question 6

When should someone be tested?

Accepted Answer

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

Question 7

Is this test for EMS patients?

Accepted Answer

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

Question 8

Does my agency need a CLIA Certificate of Waiver?

Accepted Answer

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.

Question 9

What are the Follow-Up Testing Procedures?

Accepted Answer

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

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

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