Mpox has been reported in the Democratic Republic of the Congo (DRC) for more than a decade, and the number of cases reported each year has increased steadily over that period. In July 2022, the multi[1]country outbreak of mpox was declared a Public Health Emergency of International Concern (PHEIC) as it spread rapidly via sexual contact across a range of countries where the virus had not been seen before. That PHEIC was declared over in May 2023 after there had been a sustained decline in global cases. However, last year, reported cases again increased significantly in DRC, and mpox continues to affect people around the world. The detection and rapid spread of a new clade (Clade Ib) of Monkeypox virus in eastern DRC, its detection in neighbouring countries that had not previously reported mpox, and the potential for further spread within Africa and beyond has prompted the renewal of its classification as a PHEIC as of 14 August 2024. 

On 28 August 2024 WHO published an invitation to manufacturers of Monkeypox virus IVDs:  

• Invitation to manufacturers of Monkeypox virus IVDs
• Instructions and requirements for manufacturers for EUL submission: IVD detecting Monkeypox virus nucleic acid

Please contact the In vitro diagnostics assessment team for further information at diagnostics@who.int