Zika virus (ZIKV)

A total of 60 countries and territories were currently reporting continuing mosquito-borne transmission of the Zika virus as of June 1, 2016.1

An increase in cases of microcephaly and other neurological disorders potentially associated with Zika virus infection, like Guillain-Barré syndrome, has prompted concern of transmission of the Zika virus through blood transfusions.

The FDA issued guidance to blood establishments to reduce the risk of transfusion-transmitted Zika virus that establishments in areas with active Zika transmission may collect locally if a licensed or investigation test for screening donated blood is available.2

The FDA has approved the testing of blood samples for the Zika virus using the cobas® Zika test under a specific protocol by U.S. blood screening laboratories.2 For use on cobas® 6800/8800 Systems, the cobas® Zika test under a specific protocol by U.S. blood screening laboratories.

The cobas® Zika test has not been FDA cleared or approved and is not commercially available. The  cobas® 6800/8800 Systems and cobas omni reagents are not approved in the U.S. for use in blood screening and are under FDA review.

References:

  1. World Health Organization (WHO). Situation Report on Zika Virus, Microcephaly, Guillain-Barre Syndrome. Accessed June 7, 2016.
  2. Food and Drug Administration. Recommendations for donor screening, deferral, and product management to reduce the risk of transfusion-transmission of Zika virus. Silver Spring, MD: US Department of Health and Human Services, Food and Drug Administration; 2016. Download the report here.