GENEVA, Switzerland – The World Health Organization (WHO) has officially invited manufacturers of mpox in vitro diagnostics (IVDs) to express their interest in Emergency Use Listing (EUL). This initiative underscores the ongoing dialogue concerning the need for effective diagnostics, especially in low-income regions.
Timely testing is crucial for early treatment and care, aiding in the prevention of further outbreaks. Since 2022, WHO has distributed approximately 150,000 mpox diagnostic tests worldwide, with over 25% allocated to African countries. An additional 30,000 tests are set to be delivered to African nations in the near future.
Notably, the Democratic Republic of the Congo has reported up to 1,000 suspected mpox cases this week, leading to a heightened demand for diagnostic tests. In response, WHO, along with its partners, is enhancing diagnostic capacity to tackle the surge in cases.
In a significant development, six new laboratories have been equipped for mpox diagnosis since May 2024, facilitating the decentralization of testing from urban centers to affected provinces. Two of these labs are located in South Kivu, targeting the outbreak of a newly identified viral strain, known as Ib. As a result of these initiatives, testing rates in the country have seen a fourfold increase in 2024 compared to the previous year.
To combat the new strain, WHO has revised its diagnostic testing guidelines and is collaborating with nations to implement these updates. Additionally, WHO has issued target product profiles to guide manufacturers in developing new diagnostic tests.
On August 14, 2024, WHO director-general Dr. Tedros Adhanom Ghebreyesus announced that the recent rise in mpox cases in the Democratic Republic of the Congo and other African countries represents a public health emergency of international concern (PHEIC) under the International Health Regulations (2005).
IVD manufacturers are encouraged to submit quality, safety, and performance data to WHO promptly. These tests, critical for laboratory pathogen detection, utilize PCR (Polymerase Chain Reaction) for accurate mpox diagnosis by identifying viral DNA in samples from skin lesions, while blood tests are not recommended for routine diagnosis.
The EUL process allows WHO to approve medical products like vaccines, tests, and treatments for emergency use, enabling procurement for countries lacking national approval. This initiative is particularly vital for ensuring access to essential products through UN agencies and partners during critical times.
Mpox, caused by the monkeypox virus, a member of the Orthopoxvirus genus, can spread to humans through contact with infected individuals, contaminated materials, or infected animals.
The urgent expansion of diagnostic services is essential as testing is integral to enhancing laboratory capacity, effective case investigations, contact tracing, and real-time surveillance. Ultimately, the establishment of Emergency Use Listing procedures for mpox diagnostic tests is a significant step towards enhancing public health responses.
