Geneva: The World Health Organization (WHO) announced on Friday the approval of the first diagnostic test for mpox, formerly known as monkeypox, for emergency use. This decision aims to enhance diagnostic capabilities in countries grappling with outbreaks of the disease.
The Alinity m MPXV assay, developed by Abbott Molecular Inc., is a real-time polymerase chain reaction (PCR) test designed to detect monkeypox virus DNA from swabs taken from human skin lesions. The test is intended for use by trained clinical laboratory personnel.
Dr. Yukiko Nakatani, WHO Assistant Director-General for Access to Medicines and Health Products, described the approval as “a significant milestone” in expanding testing access in affected regions. “This first mpox diagnostic test listed under the Emergency Use Listing procedure represents a significant milestone in expanding testing availability in affected countries,” she stated.
PCR testing is considered the gold standard for diagnosing mpox, and early detection is crucial for timely treatment and control of the virus. However, WHO highlighted ongoing challenges, particularly in Africa, where limited testing capacity and delays in case confirmations have exacerbated the spread of the disease. This year alone, over 30,000 suspected cases have been reported on the continent, with the Democratic Republic of the Congo (DRC), Burundi, and Nigeria accounting for the highest numbers. Alarmingly, only 37% of suspected cases in the DRC have been tested.
Mpox is an infectious disease caused by the monkeypox virus (MPXV), characterized by symptoms including a painful rash, enlarged lymph nodes, fever, headache, and muscle ache. A global outbreak began in May 2022, leading the WHO to declare a public health emergency of international concern (PHEIC).
The current surge in mpox cases in Africa is unprecedented, particularly in the DRC, and is driven by two distinct strains of the virus. Following the rapid spread of the virulent clade 1b strain, which has been detected beyond Africa, the WHO reaffirmed mpox as a PHEIC on August 14.
The Emergency Use Listing (EUL) procedure allows for the accelerated availability of critical medical products, including vaccines, tests, and treatments, during public health emergencies. On August 28, the UN agency called on manufacturers to submit expressions of interest for EUL, recognizing the urgent need to bolster global testing capacities.
To date, the WHO has received three additional submissions for EUL evaluation and is engaged in discussions with other manufacturers.
