Kenya has gained access to additional diagnostic tools for mpox, a disease that has led to the death of one individual in the country. This development follows the World Health Organization's (WHO) listing of two new mpox in vitro diagnostic tools under its Emergency Use Listing (EUL) procedure.
Currently, Kenya has confirmed 13 cases of mpox across various counties, including Nakuru, Kajiado, Bungoma, Taita Taveta, Busia, Nairobi, Mombasa, Makueni, and Kericho.
Among the newly approved tools is the Xpert mpox, a real-time PCR test developed by Cepheid, which was listed by the WHO on October 25. Designed for use on compatible GeneXpert systems, the Xpert mpox test is user-friendly and provides results in under 40 minutes, utilizing a fully automated process to detect the viral DNA of the monkeypox virus clade II.
Another diagnostic tool, the cobas MPXV assay from Roche Molecular Systems, Inc., was added to the EUL on October 14. This real-time PCR test, suitable for the cobas 6800/8800 Systems, can deliver results in approximately two hours and process multiple samples simultaneously, making it ideal for high-volume clinical laboratories.
Dr. Rogerio Gaspar, WHO’s director for regulation and pre-qualification, emphasized the importance of ensuring global access to quality diagnostic tests. "Rapid access to these listed products is essential for prompt diagnosis, timely treatment, and effectively containing the spread of the virus," he stated.
Earlier in the month, the Alinity m MPXV assay by Abbott Molecular Inc. was also included in the EUL, marking an expanded arsenal of testing options for mpox. The ongoing mpox outbreak has prompted countries worldwide to report over 40,000 suspected cases this year, many of which remain unconfirmed due to limited testing resources, particularly in low- and middle-income countries.
In response to the outbreak, WHO has also donated significant amounts of medicines to support Kenya’s healthcare system, including over 15 million tablets aimed at combating neglected tropical diseases (NTDs) and aiding mpox diagnostics. This donation, valued at Sh213 million, is intended for a mass drug administration campaign targeting more than 15 million people across 15 counties, particularly in regions with the highest disease burden. The tablets include Mebendazole, Praziquantel, Diethylcarbamazine Citrate, and Albendazole, aimed at addressing conditions such as Schistosomiasis and Soil-Transmitted Helminthiases.