REGULATORY UPDATE: Circular of Information Web Page Revised to Include Zika Testing Language Update

AABB has updated the Circular of Information web page to reflect Food and Drug Administration’s withdrawal of the July 2018 Zika virus (ZIKV) testing guidance following the agency’s determination that ZIKV is no longer a relevant transfusion-transmitted infection (RTTI) under FDA’s regulations because the virus no longer has sufficient incidence and/or prevalence to affect the potential donor population. As stated in the withdrawal, “testing for ZIKV, or pathogen reduction as an alternative to testing for ZIKV, is not necessary to comply with the requirements of 21 CFR 610.40(a)(3).”

To assist centers in updating their Circular of Information for the Use of Human Blood and Blood Components, AABB consulted with FDA regarding the least burdensome approach to satisfy FDA’s expectations. AABB recommends that blood centers add this statement to their Circular at the time testing is discontinued:

“Blood components collected between [insert date-date] were tested with a licensed nucleic acid test (NAT) for Zika Virus RNA and found to be nonreactive.”

At the time a blood center no longer has ZIKV-tested units in your distributed inventory, the center can opt to delete this statement from its Circular of Information.

The withdrawal also noted that when licensed blood establishments discontinue testing, the change must be reported to FDA in their annual report under 21 CFR 601.12(d), noting the date testing was discontinued and corresponding changes to the Circular must also be reported in the annual report.