Zika virus disease IVD EUAL status after PHEIC termination

On 18 November 2016, the Director-General declared the end of the Public Health Emergency of International Concern for Zika virus infection and to transition to a longer-term response mechanism. The WHO Prequalification Unit will no longer be assessing new applications under the Emergency Use Assessment and Listing Procedure procedure for Zika virus in vitro diagnostics (IVDs).

Consultation on the EUAL for ZIKA IVDs

A consultation with experts was held in Geneva on 14 and 15 March 2016. The purpose of the consultation was to identify and formalize the minimal technical requirements required for the documentary evidence and to invite expert review of the WHO protocols for the performance evaluations. Additionally, the consultation provided advice to WHO on how to best leverage available evidence of product safety and performance through an abbreviated EUAL assessment.