The World Health Organization (WHO) has approved its first Mpox diagnostic test for emergency use, allowing early diagnosis to facilitate timely treatment and virus control. The test, developed by Abbott Molecular Inc., is a real-time PCR test that detects monkeypox virus DNA in human skin lesion swabs. This approval, granted under WHO’s Emergency Use Listing (EUL) procedure, aims to improve global access to Mpox testing, particularly in countries dealing with outbreaks where the need for rapid and accurate testing is critical.
The Mpox diagnostic test, known as the Alinity m MPXV assay, is designed for trained laboratory personnel and enables the efficient confirmation of suspected Mpox cases. The WHO emphasized that this test is crucial for expanding diagnostic capacity in affected regions, helping to contain the virus and protect vulnerable populations. Dr. Yukiko Nakatani, WHO Assistant Director-General for Access to Medicines and Health Products, highlighted the importance of increasing access to quality medical products to assist countries in their virus containment efforts.
The approval comes amid ongoing challenges with limited testing capacity in Africa, where over 30,000 suspected Mpox cases were reported in 2024. However, only a fraction of these cases have been confirmed due to delays in testing. The WHO’s EUL procedure accelerates the availability of life-saving medical products, such as vaccines and tests, during public health emergencies. WHO has received additional submissions from other manufacturers to expand the range of Mpox diagnostic tools, ensuring broader access to quality-assured tests globally.
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