The World Health Organization (WHO) has approved the first mpox diagnostic test for emergency use. The Alinity m MPXV assay, manufactured by Abbott Molecular Inc., has been listed under the Emergency Use Listing (EUL) procedure, paving the way for improved global access to mpox testing.
This development is crucial in expanding diagnostic capacity in countries facing mpox outbreaks, particularly in Africa, where over 30,000 suspected cases have been reported this year. The Democratic Republic of the Congo, Burundi, and Nigeria have been hit the hardest, with only 37% of suspected cases tested in the Democratic Republic of the Congo.
Early diagnosis of mpox is vital for timely treatment and care, and control of the virus. The Alinity m MPXV assay is a real-time PCR test that detects monkeypox virus DNA from human skin lesion swabs. This test is designed for use by trained clinical laboratory personnel and enables efficient and effective confirmation of suspected mpox cases.
According to Dr. Yukiko Nakatani, WHO Assistant Director-General for Access to Medicines and Health Products, “This first mpox diagnostic test listed under the Emergency Use Listing procedure represents a significant milestone in expanding testing availability in affected countries.” She emphasized that increasing access to quality-assured medical products is crucial in containing the spread of the virus and protecting people, especially in underserved regions.
The EUL process accelerates the availability of life-saving medical products, such as vaccines, tests, and treatments, during public health emergencies. WHO has received three additional submissions for EUL evaluation and is working with other manufacturers to ensure a wider range of quality-assured diagnostic options.
This approval is a vital step towards controlling the spread of mpox globally. With the EUL valid until the Public Health Emergency of International Concern (PHEIC) is lifted, countries can now access critically needed tests through UN agencies and other procurement partners.
WHO/Ruth Abla ADJORLOLO
