The World Health Organization (WHO) has taken a critical step in improving global access to MPox testing by listing the first in vitro diagnostic (IVD) test under its Emergency Use Listing (EUL) procedure. The test, known as the Alinity m MPXV assay, is manufactured by Abbott Molecular Inc. and is set to enhance diagnostic capacity in countries facing MPox outbreaks. With the surge in cases, especially in regions like Africa, quick and accurate testing is crucial for early diagnosis, timely treatment, and virus control.
In 2024, over 30,000 suspected MPox cases have been reported across Africa, with the highest numbers in the Democratic Republic of the Congo, Burundi, and Nigeria. Alarmingly, only 37% of suspected cases have been tested in the Democratic Republic of the Congo, underscoring the urgent need for expanded testing capacity. Limited resources and testing delays have allowed the virus to spread more widely, making access to reliable diagnostic tools a priority.
The Alinity m MPXV assay is a real-time PCR test that detects monkeypox virus (MPXV) DNA from human skin lesion swabs, helping lab technicians confirm suspected cases quickly and effectively. This test is designed for use by trained laboratory personnel, and its ability to detect DNA from pustular or vesicular rash samples makes it a valuable tool in the fight against MPox.
Dr. Yukiko Nakatani, WHO Assistant Director-General, emphasized the significance of this milestone, stating, “This first MPox diagnostic test listed under the Emergency Use Listing procedure represents a significant milestone in expanding testing availability in affected countries.” Increasing access to reliable, quality-assured tests is key to helping countries control the spread of the virus.
As the EUL process continues, WHO has received three more submissions for evaluation, and ongoing discussions with other manufacturers aim to ensure a broader range of diagnostic options.
The approval of the Alinity m MPXV assay will remain valid as long as the Public Health Emergency of International Concern (PHEIC) is in effect, ensuring countries have access to critical diagnostic tools.
Reference:
https://www.who.int/news/item/03-10-2024-who-approves-first-MPox-diagnostic-test-for-emergency-use–boosting-global-access
