WHO lists the first MPXV IVD under the emergency use listing procedure

Today WHO listed the first MPXV in vitro diagnostic under the Emergency Use Listing (EUL) Procedure. The Alinity m MPXV assay manufactured by Abbott Molecular Inc., a real-time PCR test intended for the qualitative detection of DNA from monkeypox virus, was assessed by WHO following the abridged EUL assessment procedure.

eul-mpxv_list-of-mpxv-ivds.pdf (who.int)

A dedicated WHO press release is available: WHO approves first mpox diagnostic test for emergency use, boosting global access

The EUL procedure for IVDs to detect Monkeypox virus is intended to expedite the availability of IVDs needed in PHEIC situations and, in that context, to assist interested UN procurement agencies and Member States in determining the acceptability of using specific products for time limited procurement.

Mpox disease Pandemic - Emergency Use Listing Procedure (EUL) for IVDs | WHO - Prequalification of Medical Products (IVDs, Medicines, Vaccines and Immunization Devices, Vector Control)

To date manufacturers of three other MPXV assays have submitted their applications for WHO EUL assessment. The status of each EUL application can be consulted on the WHO website:

eul-mpxv_status-of-ongoing-applications.pdf (who.int)