Zika virus disease (IVDs) emergency use assessment and listing (EUAL) status after PHEIC termination
On 18 November 2016, the Director-General declared the end of the Public Health Emergency of International Concern (PHEIC) for Zika virus infection and to transition to a longer-term response mechanism. The WHO Prequalification Team will no longer be accepting new applications under the Emergency Use Assessment and Listing Procedure (EUAL) procedure for Zika virus IVDs. However, all IVD applications accepted prior to this announcement will continue to be assessed by WHO under the EUAL procedure.
The EUAL procedure was developed to expedite the availability of IVDs needed in public health emergency situations. It is intended to assist interested procurement agencies and Member States on the suitability for use of a specific IVD, based on a minimum set of available quality, safety, and performance data.
The assessment process may include the following sequential steps:
- step 1: review of the manufacturer’s Quality Management System documentation;
- step 2: review of the documentary evidence of safety and performance, including labelling and product performance specifications, and associated verification and validation studies;
- step 3: performance evaluation of limited scope to verify critical analytical and clinical performance characteristics.
Public Reports: WHO list of IVDs for Zika virus disease accepted for procurement through the EUAL Procedure for IVDs.
Public report for the AccuPower® ZIKV (DENV, CHIKV) Multiplex Real-Time RT-PCR Kit (EAZ 0006-004-00)
Public report for RealStar® Zika Virus RT-PCR Kit 1.0 (EAZ 0003-002-00)
Instructions on compilation of documentary evidence and QMS requirements for EUAL review
The manufacturer should compile documentary evidence as part of their submission for EUAL review as prescribed in the following documents:
- For IVDs detecting antibodies to Zika Virus:
Document PQDx_239 Instructions for Submission Requirements: In Vitro Diagnostics (IVDs) Detecting Antibodies to Zika Virus
New! The above document has been revised to include a requirement for additional testing of P falciparum positive specimens.
- For IVDs detecting Zika Virus nucleic acid or antigen:
WHO will review all documentation submitted in order to assess available evidence in support of the product’s safety, quality and performance.
EUAL Zika Update
Consultation on the EUAL for ZIKV IVDs
A consultation with experts was held in Geneva on 14 and 15 March 2016. The purpose of the consultation was to identify and formalise the minimal technical requirements required for the documentary evidence (refer Step 2) and to invite expert review of the WHO protocols for the performance evaluations (refer Step 3). Additionally, the consultation provided advice to WHO on how to best leverage available evidence of product safety and performance through an abbreviated EUAL assessment.