Impact of Zika Virus (ZIKV) Risk on Public Cord Blood Banking

Abstract

Introduction Zika virus (ZIKV) is identified by the U.S. Food and Drug Administration (FDA) as a relevant communicable disease agent. Mothers at risk for ZIKV exposure are declared ineligible donors. Objective This study aimed to analyze the impact of ZIKV on public cord blood (CB) banking. Methods Cord blood units (CBU) were collected from healthy newborns at five collection sites of the National Cord Blood Program (NCBP), which serves diverse populations, in New York, Virginia, and Georgia. Detailed travel and residency information and all other risks for both parents, as well as maternal and infant hospital records were reviewed. Information was screened by an electronic eligibility assignment system and reviewed by our medical staff. Results From March 2016 to December 2018, 4,153 CBU were banked. Of those, 1,141 (27.5%) were from ineligible donors, and 851 (74.6%) of those ineligible were related to ZIKV; 803 had only ZIKV risk, and 48 had ZIKV and other risks. The monthly banking rates of all ineligible and ZIKV-ineligible CBU are shown in Fig. 1 (average: 20.5%). ZIKV-risk CBU were as high as 91% of all ineligible CBU in white Hispanic donors, and lower (67%-70%) in Asian, black, and white non-Hispanic donors. Potency evaluation showed no differences in the total nucleated cell count and colony-forming unit count among CBU from eligible donors, from donors with ZIKV-risk, and from donors with other risks, although CD34 counts tended to be lower in the ZIKV-risk donors. A follow-up questionnaire was sent 1 year after delivery to donor mothers; 196 of donors with ZIKV-risk have responded, and all infants are reported to be healthy. Five ZIKV-ineligible CBU have been provided for transplant (Urgent Medical Need). Discussion Ineligible donor CBU cannot be licensed or included in the National Cord Blood Inventory (NCBI) and funded. The uncertain ZIKV-risk may deter clinicians from using them for transplant; therefore, the impact of ZIKV-risk on CB banking is significant, indirectly increasing overall costs and affecting the social value of CB. Studies are needed to define more accurately the risk for the infant donor and the CBU. Furthermore, an FDA-approved screening test for CB donors is urgently needed.