Summary

Eurofins Scientific has launched the Mplex Mpox, Orthopox real-time PCR assay for the qualitative detection and differentiation of the mpox virus from other orthopoxviruses.

Takeaways

  1. Global Outbreak Response: The real-time PCR assay supports early detection and monitoring of the 2024 mpox outbreak declared a Public Health Emergency by the WHO.
  2. Technical Robustness: The assay remains effective despite genetic variations in the virus that can affect other PCR assays.
  3. International Support: Eurofins is distributing the assay globally and providing kits to African health authorities in need.

Eurofins Scientific, a global provider bioanalytical testing, has announced the availability of its real-item PCR assay for the simultaneous qualitative detection of the mpox virus and its differentiation from other viruses from the orthopox family, 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 Concern1, is likely to lead to “more sporadic imported cases to the European continent”2, which will require monitoring, testing and diagnostics support.

Real-Time PCR Assay Aids Early Detection

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, part of the international network of Eurofins companies, in response to the 2022 mpox epidemic. The real-time 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 Gold Standard Diagnostics Mplex Mpox, Orthopox assay remains unaffected by this deletion based on bioinformatic analysis.

Eurofins is making this new real-time PCR assay available to its laboratories serving health authorities around the world where required and applicable and has set aside test kit contingents for donation to African countries’ health authorities who may need these tests.

References
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