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ISDH Provides Antigen Testing Guidance - IHCA

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ISDH Provides Antigen Testing Guidance

Posted Sep 25, 20206 min Read

Regulatory & Clinical
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On September 25, 2020, the Indiana State Department of Health provided guidance on the use of antigen tests, which applies to the Quidel Sofia and BD Veritor point of care (POC) machines and the Abbott BinaxNow Cards.  The entirety of the guidance can be found here and outlines when a PCR is or is not needed following a positive antigen test and the applicable protocols.  The guidance also notes that to determine routine testing frequency, nursing facilities should utilize the county positivity rate data on the CDC’s website.  As a reminder, nursing facilities should select the same day each week to check the CDC’s data file and maintain or update the frequency of the facility’s routine testing accordingly.

True Positives

If a facility has a staff member or resident who tests positive on an antigen test and meets any of the below criteria, then the positive is to be considered a true positive, and a PCR test is not recommended or needed:

  • Person being tested is symptomatic with COVID-19 symptoms;
  • Person being tested is a close contact of someone who tested positive for COVID-19;
  • The facility is undergoing outbreak testing; and/or
  • The county positivity rate (according to the CDC positivity data) is greater than 10%.

When there is a true positive, the following should occur:

  • If the true positive is an employee, the person should be sent home for isolation and adhere to the CDC’s Return to Work criteria.  For IHCA/INCAL’s summary on the CDC’s Return to Work criteria, please click here.
  • If the true positive is a resident, the person should be placed in Transmission-Based Precautions.  For IHCA/INCAL’s summary on the CDC’s criteria for Discontinuation of Transmission-Based Precautions, please click here.
  • Outbreak testing should be initiated, if it is not already occurring.  CMS’s QSO 20-38 defines outbreak as any new case among staff or any new nursing home-onset case in a resident; under an outbreak, all staff and residents should be tested, and all staff and residents who tested negative should be tested every 3-7 days until no new cases are identified among staff or residents for a period of at least 14 days since the most recent positive result.
  • The antigen test should be reported through the POC REDCap survey.

Probable Positives

If a resident or staff tests positive on an antigen test and none of the above true positive criteria are met, then the person should be considered probable positive, and a follow-up PCR test is recommended. Additionally:

  • While waiting for the confirmatory results:
    • If the probable positive is an employee, the employee should stay home and isolate until the results are received.  If the employee is contacted by a contact tracer, the employee should inform the contact tracer that he/she has a pending PCR test after a low suspicion antigen positive.
    • If the probable positive is a resident, the resident should be placed in Transmission-Based Precautions.  The resident does not need to be moved to a red zone, but the resident should be moved to an individual room and proper PPE should be utilized.
  • The facility:
    • Should wait to report the case in the POC REDCap survey until the PCR test results are confirmed.
    • Proceed with placing the antigen test results in the test reporting REDCap form.
    • Wait to initiate outbreak testing until the PCR test result is received.

If the follow-up PCR test is positive from the probable positive antigen test:

  • Outbreak testing should be initiated.
  • If the positive is an employee, the person should be sent home for isolation and adhere to the CDC’s Return to Work Criteria.  The employee should also be encouraged to contact the state’s contact tracing program (1-833-670-0067) if he/she had previously notified the state of a pending status.
  • If the positive is a resident, the person should be placed in Transmission-Based Precautions.
  • The positive PCR test should be reported into the regular REDCap survey.

If the follow-up PCR test is negative from the probable positive antigen test, then the person will be considered negative (employees may return to work and residents may return to activities), but the facility should continue to monitor for symptoms.  The facility does not need to initiate outbreak testing and does not need to report the case in REDCaps.

Please note, assisted living communities are not required to utilize antigen tests or conduct routine testing, as required of nursing facilities under QSO 20-38.  However, the antigen tests can be utilized by assisted living communities for baseline or outbreak testing.  As a reminder, any antigen tests that are conducted (both positive and negative results) must be reported through the POC REDCap survey.