We are pleased to announce that two additional MPXV tests have been listed under WHO's Emergency use listing procedure. Mpox disease PHEIC - Emergency Use Listing Procedure (EUL) for IVDs | WHO - Prequalification of Medical Products (IVDs, Medicines, Vaccines and Immunization Devices, Vector Control)
The EasyNAT Monkeypox Virus Assay is an automated, in vitro nucleic acid amplification test used to quantitatively detect the DNA of monkeypox virus clade I and clade II (including Ib) in lesion swabs specimens from individuals suspected of monkeypox virus infection. The test kit can be used as an aid in the clinical diagnosis of monkeypox virus infection. The product is intended for professional use only. The product is manufactured by UStar Biotechnologies (Hangzhou) Ltd.
The PortNAT Monkeypox Virus Test is an in vitro diagnostics test for the qualitative detection of DNA of monkeypox virus clade I and clade II (including Ib) in lesion swabs specimens from individuals suspected of monkeypox virus infection. The product is intended for professional users with laboratory experience and non-laboratory professionals who received training on the use of this product. The product is manufactured by UStar Biotechnologies (Hangzhou) Ltd.
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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.