WHO Approves First Mpox Diagnostic Test for Emergency Use

The test is designed to detect monkeypox virus (clade I/II) DNA using real-time PCR technology from human skin lesion swabs

The World Health Organization (WHO) has announced the emergency use approval of the first mpox in vitro diagnostic (IVD) test under its Emergency Use Listing (EUL) procedure. The Alinity m MPXV assay, developed by Abbott Molecular Inc., has been approved to aid in addressing the rising demand for Mpox testing, especially in outbreak regions.

The test is designed to detect monkeypox virus (clade I/II) DNA using real-time PCR technology from human skin lesion swabs. It is expected to enhance diagnostic capacity in countries experiencing high case numbers, where timely and accurate testing is crucial for effective treatment and virus control. Mpox outbreaks in regions like the Democratic Republic of the Congo, Burundi, and Nigeria have seen delayed testing due to limited resources. WHO reported that only 37% of suspected cases in the Democratic Republic of the Congo have been tested in 2024, contributing to the virus’s continued spread. "This first mpox diagnostic test listed under the EUL procedure represents a significant milestone in expanding testing availability in affected countries,” said Dr. Yukiko Nakatani, WHO Assistant Director-General for Access to Medicines and Health Products.

Additionally, three more submissions for EUL review have been received by WHO, and discussions are underway with other manufacturers to make sure a greater variety of diagnostic choices. The approval remains valid as long as the Public Health Emergency of International Concern (PHEIC) is in effect.