Gold Standard Diagnostics Frankfurt announces the availability of its innovative PCR assay for the simultaneous qualitative detection of the mpox virus and its differentiation from other viruses from the orthopox family (smallpox, cowpox, buffalopox, etc.) - the Mplex Mpox, Orthopox assay.
European Centre for Disease Prevention and Control Director Pamela Rendi-Wagner has noted that the 2024 outbreak of mpox in several African countries, which WHO has declared a Public Health Emergency of International Concern[1], is likely to lead to “more sporadic imported cases to the European continent”[2], which will require monitoring, testing and diagnostics support.
Early detection, surveillance and data is essential to efficient infectious disease control. Mplex Mpox, Orthopox real-time PCR assay was developed by Gold Standard Diagnostics Frankfurt GmbH in response to the 2022 mpox epidemic. The PCR assay has been evaluated and validated by the Institute of Health Carlos III (ISCIII) in Spain and the French National Reference Center (CNR-LE) and is immediately available as an RUO assay.
This 2024 outbreak is linked to the MPXV Clade I sublineage, a virus variant that carries a genome deletion affecting binding sites for primers and probes in certain real-time PCR assays, potentially leading to assay failure. The Mplex Mpox, Orthopox assay remains unaffected by this deletion based on bioinformatic analysis.
For further information please contact: order@goldstandarddiagnostics.eu
[1] WHO declares mpox virus a public health emergency of international concern | UN News
[2] Mpox Africa Outbreak Needs More Testing, Europe CDC Chief Says - Bloomberg