WHO greenlights two new mpox tests to enhance detection efforts.

The World Health Organization (WHO) has added two new in vitro diagnostic tests for mpox to its Emergency Use Listing (EUL) procedure, aiming to enhance quality-assured testing options. This announcement was made in a statement on Wednesday.....Read Full Article>>

According to the WHO, the EUL is based on a thorough review of quality, safety, and performance data that adheres to international standards, particularly addressing the specific needs of low- and middle-income countries. The organization highlighted that Polymerase Chain Reaction (PCR) testing, which detects viral DNA, is regarded as the gold standard for diagnosing mpox infections.

One of the newly listed tests is the Xpert Mpox, a real-time PCR test developed by Cepheid. It was included in the EUL procedure on October 25 and is designed for use with compatible GeneXpert systems. The Xpert Mpox test is user-friendly and provides results within 40 minutes. Once the cartridge is inserted into the system, the entire process is automated, detecting the viral DNA of monkeypox virus clade II.

The GeneXpert system serves as a near-point-of-care testing option, supporting decentralized testing efforts.

Another PCR-based test, the cobas MPXV assay developed by Roche Molecular Systems, Inc., was listed on October 14 for use on the cobas 6800/8800 Systems. This real-time PCR test can detect both mpox clades and delivers results in two hours. It is capable of processing multiple samples simultaneously, making it suitable for clinical laboratories that manage large test volumes.

WHO emphasized that ensuring global access to mpox diagnostic tests is crucial for efficient testing in regions affected by mpox outbreaks. “Rapid access to these listed products is vital not only for prompt diagnosis and timely treatment but also for effectively containing the spread of the virus,” the organization stated.

Dr. Rogerio Gaspar, WHO Director for Regulation and Prequalification, noted that the Alinity m MPXV assay, manufactured by Abbott Molecular Inc., was previously listed under EUL on October 3. In 2024, 18 countries reported over 40,000 suspected mpox cases, with many remaining unconfirmed due to limited testing capacity, especially in low- and middle-income countries.

In the Democratic Republic of the Congo, the hardest-hit nation, testing significantly increased in 2024 following efforts to decentralize testing with support from WHO and partners. However, only 40-50% of suspected cases have been tested.

WHO is collaborating with manufacturers of EUL-listed products and national regulatory authorities in affected countries to facilitate domestic registration or emergency listing. “Fast-tracking approvals and applying reliance principles will enhance access to quality-assured mpox tests,” Gaspar stated.

Overall, WHO has received over 60 expressions of interest for the EUL review of mpox diagnostic tests, with seven progressing to EUL applications. Two products are currently under review, and two more are expected soon. The status of active applications and listed mpox diagnostics under WHO’s EUL procedure can be found on the WHO website.