WHO is pleased to announce that a fourth MPXV IVD was listed on 6 March 2024 under the WHO Emergency Use Listing (EUL) procedure. The RADIONE Mpox Detection Kit manufactured by KH Medical Co., Ltd. is an automated PCR test intended to detect MPXV DNA (including clade I and clade II) in human skin lesion specimens obtained from patients with signs and symptoms of monkeypox infection. The kit is intended to be used with the RADIONE Universal DNA/RNA Extraction Kit on the RADIONE instrument to ensure accurate results.
IVD listed by WHO under the EUL procedure can be consulted here.
WHO continues performing EUL assessments of MPXV IVDs with the aim of providing options among several quality-assured tests meeting WHO EUL requirements. The status of active EUL applications is available here.