On 25 October, WHO included the Xpert Mpox test, developed by Cepheid, in its EUL. On 25 October, WHO included the Xpert Mpox test, developed by Cepheid, in its EUL. On 25 October, WHO included the Xpert Mpox test, developed by Cepheid, in its EUL. In a bid to enhance quality-assured testing options, the World Health Organization (WHO) has added two additional monkeypox (mpox) in vitro diagnostics to its Emergency Use Listing (EUL) procedure. This initiative seeks to address the need for reliable diagnostic tools, particularly in low- and middle-income countries (LMICs).
WHO's EUL process is based on a thorough evaluation of quality, safety, and performance data, ensuring compliance with international standards to meet the specific healthcare needs of affected regions. The gold standard for diagnosing mpox, caused by the monkeypox virus, remains Polymerase Chain Reaction (PCR) testing, which detects viral DNA.
On 25 October, WHO included the Xpert Mpox test, developed by Cepheid, in its EUL. This real-time PCR test, designed for use with compatible GeneXpert systems, offers user-friendly operation and delivers results in under 40 minutes. Once the cartridge is inserted, the automated process enables real-time PCR to identify the viral DNA of monkeypox virus clade II, making it a suitable near-point-of-care testing option that supports decentralised testing initiatives.
Additionally, the cobas MPXV assay, produced by Roche Molecular Systems, Inc., was listed on 14 October 2024. Intended for the cobas 6800/8800 Systems, this real-time PCR test can detect both mpox clades and provides results in under two hours. It is capable of processing multiple samples simultaneously and is well-suited for clinical laboratories that handle large volumes of tests.
Dr Rogerio Gaspar, WHO Director for Regulation and Prequalification, highlighted the importance of global access to diagnostic tests that meet WHO standards. "Rapid access to those listed products is critical not only for prompt diagnosis and timely treatment but also for effectively containing the spread of the virus," he stated.
Earlier this month, the Alinity m MPXV assay, manufactured by Abbott Molecular Inc., was also added to the EUL on 3 October.
In 2024, more than 40,000 suspected mpox cases have been reported across 18 countries, with many remaining unconfirmed due to limited testing capacity, especially in LMICs. The Democratic Republic of the Congo, the hardest-hit nation, has seen an increase in testing this year, largely due to decentralisation efforts supported by WHO and its partners. However, the proportion of tested cases continues to be low, covering only 40-50% of suspected cases.
To improve access to quality-assured mpox tests, WHO is working with manufacturers of EUL-listed products and national regulatory authorities in affected countries. By fast-tracking approvals and applying reliance principles, the organisation aims to facilitate domestic registration or emergency listing of these vital diagnostic tools.
Overall, WHO has received over 60 expressions of interest for the EUL review of mpox diagnostic tests. Among these, seven have progressed to EUL applications, with two products currently under review and two more expected soon.