On 14 October 2024 WHO listed the second mpox IVD under the WHO Emergency Use Listing (EUL) procedure. The cobas® MPXV manufactured by Roche Molecular Systems, Inc., is a PCR test intended to detect DNA from Monkeypox virus in human lesion swab specimens from individuals suspected of monkeypox infection. The cobas® MPXV is intended for use on the cobas® 6800/8800 Systems.
On 28 October 2024 WHO listed the third mpox IVD under the WHO Emergency Use Listing (EUL) procedure. The Xpert Mpox manufactured by Cepheid is a is a a real-time PCR test intended for the qualitative detection of DNA from monkeypox virus clade II and non-variola Orthopoxvirus DNA in human lesion swab specimens (i.e., swabs of acute pustular or vesicular rash) from individuals suspected of mpox by their healthcare provider.
On 6 March 2025 WHO listed the fourth mpox IVD 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 mpox 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.