Implementation of the US Department of Health and Human Services Zika Specimen Repository and Its Effect on Zika Diagnostic Test Development, 2016

摘要

This study describes the efforts and outcomes associated with the establishment of a clinical sample repository during the 2016 Zika virus epidemic. To overcome the challenge of limited access to clinical samples to support diagnostic test development, multiple US Department of Health and Human Services (HHS) agencies formed a partnership to create the HHS Zika Specimen Repository. In 2016-2017, the Biomedical Advanced Research and Development Authority and the Centers for Disease Control and Prevention collected patient specimens (4420 convalescent sera aliquots from 100 donors and 7171 plasma aliquots from 239 donors), confirmed Zika virus test results, assembled 1 panel for molecular testing (n = 25 sets) and 7 panels for serologic testing (n = 92), and distributed the panels to test developers. We manufactured 8 test panels and distributed 74 sets of panels to 32 commercial companies, public health partners, and research institutions. Manufacturers used these panels to generate data that supported 14 US Food and Drug Administration (FDA) emergency use authorizations and 1 FDA approval. To develop a repository that can respond immediately to future disease outbreaks, we recommend that organizations pre-position procedures, resources, and partnerships to optimize each partner's contribution.