WHO lists additional diagnostic tests for mpox for emergency use

As part of ongoing efforts to improve quality assurance testing capabilities, the World Health Organization (WHO) has included two additional mpox in vitro diagnostics in its Emergency Use List (EUL) procedure. The WHO EUL is based on a review of data on quality, safety and efficacy in line with international standards, while addressing the specific needs of low- and middle-income countries (LMICs).

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

On October 25, WHO listed Xpert Mpox, a real-time PCR test manufactured by Cepheid under its EUL procedure. This test is designed for use on compatible GeneXpert systems. The Xpert Mpox test is easy to use and gives results in less than 40 minutes. Once the cartridge is placed in the system, the process is fully automated, with real-time PCR detecting clade II monkeypox virus DNA. The GeneXpert system is a near-point-of-care testing option that can support decentralized testing.

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

“Ensuring global access to mpox diagnostic tests that meet WHO standards for quality, safety and performance is essential for effective and efficient testing in settings affected by mpox outbreaks,” said Dr Rogerio Gaspar, WHO Director of Regulation and retraining. “Quick access to these products is crucial not only for quick diagnosis and timely treatment, but also for effective suppression of the spread of the virus.”

WHO previously mentioned Alinity m MPXV test, manufactured by Abbott Molecular Inc. according to the EUL on October 3.

In 2024, 18 countries reported more than 40,000 suspected cases of measles, with the majority remaining unconfirmed due to limited testing capacity, particularly in LMICs. In the Democratic Republic of Congo — the worst-affected country — testing increased significantly in 2024, following efforts to decentralize testing with support from WHO and partners. However, the proportion of tested cases is still low and accounts for 40-50% of suspected cases.

WHO is working with manufacturers of EUL-listed products and national regulatory authorities in affected countries to facilitate domestic registration or urgent listing. Fast-track approvals and application of reliability principles will improve access to quality-assured mpox tests.

In total, WHO received more than 60 expressions of interest for the EUL review of diagnostic tests for mpox. Seven of these have progressed to EUL applications, with 2 products currently under review and 2 more expected soon.

You can see the status of active applications and specified mpox diagnostics according to the WHO EUL procedure at WHO website.

Editor's note

After WHO Director-General Dr. Tedros Adhanom Ghebreyesus declared mpox a Public Health Emergency of International Concern (PHEIC) on 14 August 2024, WHO invited manufacturers of mpox in vitro diagnostics to submit expression of interest for the emergency list on August 28, 2024.

The WHO EUL is a risk-benefit assessment designed to meet urgent needs during public health emergencies based on limited available data, accelerating the availability of life-saving medical products such as vaccines, tests and treatments. Assists in procurement decisions by the UN, partner agencies and Member States at the international, regional and national levels. Under the EUL, manufacturers must commit to continuing to generate any missing information to meet prequalification requirements. Once this information is available, a prequalification request should be submitted to complete the full process for obtaining a referral for international procurement in both emergency and non-emergency situations.