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The World Health Organization (WHO) has added two additional mpox in vitro diagnostic products to its Emergency Use Listing (EUL) as part of ongoing efforts to improve quality-assured testing options. The WHO EUL is based on the analysis of quality, safety and efficacy data in accordance with international standards and takes into account the specific needs of low- and middle-income countries (LMIC).

The polymerase chain reaction (PCR) test, which detects viral DNA, is considered the gold standard for diagnosing MPO infection.

Tests are already included

October 25, The WHO included Xpert Mpox, a real-time PCR test manufactured by Cepheid, in its watchlist for the use of the vaccine. This test is intended for use on compatible GeneXpert systems. The Xpert Mpox test is easy to use and provides results in less than 40 minutes. Once the cartridge is installed in the system, the process is fully automated and real-time PCR detects monkeypox virus clade II viral DNA. The GeneXpert system is a point-of-care testing option that can support decentralized testing.

Another PCR-based option is the cobas MPXV assay developed by Roche Molecular Systems.Inc. was registered on October 14, 2024. It is intended for use on cobas 6800/8800 systems. This tool is a real-time PCR test capable of detecting both mpox clades and providing results in less than 2 hours. It can process multiple samples simultaneously and is suitable for clinical laboratories performing high volume tests.

“Ensuring global access to mpox diagnostic tests that meet WHO standards for quality, safety and efficacy is essential for efficient and effective testing in settings affected by mpox outbreaks.said Rogerio Gaspar, Director of Regulatory Affairs and Prequalification at WHO. “Rapid access to these listed products is essential not only for rapid diagnosis and timely treatment, but also to effectively contain the spread of the virus,” he added.

WHO previously EUL listed the Alinity m MPXV assay, manufactured by Abbott Molecular Inc., on October 3.

Several screening tests

In 2024 18 countries have reported more than 40,000 suspected cases of smallpox, most of which remain unconfirmed due to limited testing capacity, especially in low- and middle-income countries.. In the Democratic Republic of the Congo (the worst affected country), testing volumes increased significantly in 2024 due to efforts to decentralize testing supported by WHO and its partners. However, the proportion of cases analyzed remains low, ranging from 40 to 50% of suspected cases.

WHO andworks with manufacturers of products listed as potentially hazardous substances, as well as with national regulatory authorities in affected countries, to facilitate national registration or listing of hazardous substances.. Simplifying assertions and applying trust principles will improve access to quality-assured mpox tests.

In total, WHO received more than 60 expressions of interest to consider mpox diagnostic tests under the EUL. Seven of these have been converted to EUL applications, two products are currently under review and two more are expected to be introduced soon.

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