In an effort to improve quality-assured testing options, the World Health Organization (WHO) has added two additional in vitro diagnostics for monkeypox (mpox) to its listing process. emergency use (EUL). This initiative aims to address the need for reliable diagnostic tools, particularly in low- and middle-income countries (LMICs).

The WHO EUL process is based on a thorough assessment 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 the polymerase chain reaction (PCR) test, which detects viral DNA.

On October 25, the WHO included in its EUL the Xpert Mpox test, developed by Cepheid. This real-time PCR test, designed for use with compatible GeneXpert systems, offers user-friendly operation and provides results in less than 40 minutes. Once the cartridge is inserted, the automated process allows real-time PCR to identify monkeypox virus clade II viral DNA, making it a suitable point-of-care testing option that supports supports decentralized testing initiatives.

Additionally, the cobas MPXV test, produced by Roche Molecular Systems, Inc., was listed on October 14, 2024. Intended for cobas 6800/8800 systems, this real-time PCR test can detect both mpox clades and provides results in less than two hours. . It is capable of processing multiple samples simultaneously and is ideal for clinical laboratories that process large volumes of tests.

Dr Rogerio Gaspar, WHO Director for Regulation and Prequalification, highlighted the importance of global access to diagnostic tests meeting WHO standards. “Rapid access to these listed products is essential not only for rapid diagnosis and rapid treatment, but also to effectively contain the spread of the virus,” he said.

Earlier this month, the Alinity m MPXV test, manufactured by Abbott Molecular Inc., was also added to the EUL on October 3.

In 2024, more than 40,000 suspected cases of mpox have been reported in 18 countries, many of which remain unconfirmed due to limited testing capacity, particularly in LMICs. The Democratic Republic of Congo, the hardest-hit country, has seen an increase in testing this year, largely due to decentralization efforts supported by WHO and partners. However, the proportion of cases tested remains low, covering only 40 to 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 expediting approvals and applying reliability principles, the organization aims to facilitate national registration or emergency listing of these life-saving diagnostic tools.

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