Zika Virus Donor Screening

Principle:

The flavivirus Zika virus can be transmitted through mosquito bites from Aedes aegypti and Aedes albopticus species.  The outbreaks have been associated with severe birth defects, especially CNS (microcephaly).  Although it is not clear if it can be definitely transmitted by blood transfusion, major international organizations, UK National Health Service,  World Health Organization, and the American Red Cross have instituted temporary deferrals for travelers from those affected areas.

Change Log:

This bulletin reflects recommendations made by the FDA Bulletin dated 1/3/16, FDA issues recommendations to reduce the risk of Zika virus transmission by human cell and tissue.

Policy:

  1. Travel History:

As part of the usual screening questionnaire, donors must be asked if they have travelled to an affected area (refer to http://www.cdc.gov/zika/geo/index.html or http://wwwnc.cdc.gov/travel/page/zika-information).

  1. If so, then they are to be temporarily deferred from blood donation for 28 days upon leaving that area.
    1. A specific question about Zika travel history is now active in the Medinfo Hematos IIG questionnaire.
  2. Clinical Symptoms:
    1. Donors should be asked if they have now or within the past 28 days had any of the following symptoms:
      1. Fever
      2. Rash
      3. Joint Pain
      4. Conjunctivitis (red eyes)
      5. Muscle Pain
      6. Headache
    2. If a donor has any of the above symptoms, they should be deferred for 28 days from blood donation after visiting the Blood Donor Center.
  3. Sexual History:
    1. Blood donors should be deferred for 28 days after the last sexual contact with a man who has been diagnosed with Zika virus or who traveled to or resided in an area with active transmission of Zika virus in the 3 months prior to that instance of sexual contact.
  4. Re-entry of blood donor after deferral:
    1. Defer for 4 weeks after the resolution of symptoms a donor with a history of Zika virus infection.
    2. A deferred donor may be considered eligible after the deferral period has lapsed provided that all donor eligibility criteria are met.
  5. Cellular product and other tissue donors:
    1. Living Donors of Cellular and Tissues:  Donors should be considered ineligible if they were diagnosed with Zika virus infection, were in an area of active Zika virus transmission, or had sex with a male with either of those risk factors within the past SIX (6) months.
    2. Donors of umbilical  cord, placenta, or other gestational tissues should be considered ineligible if they have any of the above risk factors at any point in their pregnancy
    3. Deceased (non-heart beating) donors:  Donors should be considered ineligible if they were diagnosed with Zika virus infection within the past SIX (6) months

References:

  1. Center for Biologics Evaluation and Research CBER Guidance for Industry Recommendations for Donor Screening, Deferral, and Product Management to Reduce the Risk of Transfusion-Transmission of Zika Virus, February 2016
  2. AABB Association Bulletin #16-03 Zika, Dengue, and Chikungunya Viruses,
  3. Blood Banks Establish Waiting Period For Prospective Donors Returning From Zika-Affected Areas, AABB Newsbrief, 4/2/16
  4. FDA Bulletin 1/3/16, FDA issues recommendations to reduce the risk of Zika virus transmission by human cell and tissue.
  5. Zika travel information. Centers for Disease Control and Prevention website. http://wwwnc.cdc.gov/travel/page/zika-travel-information, 16/2/16
  6. U.S. CDC Issues Zika Travel Advisory for 11 Southeast Asian Countries, Medscape, 1/10/16

Prepared By:

Zeyd Merenkov, MD, FCAP, FASCP

Senior Consultant/Head, Transfusion Medicine/LIS