Guidance on Zika transmission
Monday, March 14, 2016
As you are likely aware, we are in the midst of a Zika virus outbreak in the Americas. Zika is transmitted by mosquitos and is an asymptomatic or self-limited illness in the vast majority of infected persons. Relatively little is known about how the virus behaves in immunosuppressed persons. However, Zika is an emerging infectious disease and we need to consider its impact on transplant recipients and organ donors. There exists a potential for donor-derived Zika virus infectious with unknown consequencces for recipients.
The FDA issued the following guidance for industry on donor screening recommendations to reduce the risk of transmission of Zika virus by human cells, tissues, and cellular and tissue-based products.
Additionally, the OPTN/UNOS Ad Hoc Disease Transmission Advisory Committee (DTAC) developed the following guidance document with collaboration from the AST and ASTS in February 2016. It also provides expert advice on organ donor screening and recipient testing for Zika virus.
Availability of DRAI Addenda to Assist with Screening for Risk of Zika Virus Infection
To assist with screening donors for risk of Zika virus (ZIKV) infection, an addendum and relevant flowcharts are available for use with any of the three Uniform Donor Risk Assessment Interview (DRAI) forms. These are adaptable for use with any DRAI form style. Separate tools have been created for a "Deceased Donor" and for a "Living Donor – Delivery Mother – Birth Tissue." Documents can be accessed at these links on the AATB website:
NOTE: As knowledge is gained regarding risk of ZIKV infection associated with donation of organs, tissues or eyes, be aware that updates to the addenda and/or the flowcharts can occur. Contact Scott Brubaker if you have questions after carefully reviewing all documents and published guidance.
Check these links frequently to receive the most up-to-date information.