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WHO approves first mpox diagnostic test for emergency use, increasing global access
The World Health Organization (WHO) has included the first mpox in vitro diagnostic (IVD) in its Emergency Use List (EUL) procedure, an important step in improving global access to mpox testing. Approval for emergency use Alinity m MPXV test, manufactured by Abbott Molecular Inc.will be instrumental in expanding diagnostic capacity in countries facing measles outbreaks, where the need for rapid and accurate testing has skyrocketed. Early diagnosis of mpox enables timely treatment and care and control of the virus.
Limited testing capacity and delays in confirming measles cases persist in Africa, contributing to the continued spread of the virus. In 2024, more than 30,000 suspected cases were reported across the region, with the highest numbers in the Democratic Republic of the Congo, Burundi and Nigeria. In the Democratic Republic of Congo, only 37% of suspected cases were tested this year.
The presence of monkeypox virus is confirmed by nucleic acid amplification testing (NAAT), such as real-time or conventional polymerase chain reaction (PCR), as outlined in WHO interim guidelines on diagnostic testing for monkeypox virus (MPXV). And the recommended specimen type for diagnostic confirmation of monkeypox virus (MPXV) infection in suspected cases is lesional material.
The Alinity m MPXV test is a real-time PCR test that allows the detection of monkeypox virus (clade I/II) DNA from human skin lesion swabs. It is specifically designed for use by trained clinical laboratory personnel skilled in PCR techniques and IVD procedures. By detecting DNA from pustular or vesicular rash samples, laboratory and healthcare workers can efficiently and effectively confirm suspected cases of mpox.
“This first mpox diagnostic test listed in the emergency list process represents a significant milestone in expanding the availability of testing in affected countries,” said Dr Yukiko Nakatani, WHO's Assistant Director-General for Access to Medicines and Health Products. “Increasing access to quality-secured medical products is critical to our efforts to help countries contain the spread of the virus and protect their people, especially in underserved regions.”
The EUL process accelerates the availability of life-saving medical products, such as vaccines, tests and treatments, in the context of an International Public Health Emergency (PHEIC). On August 28, 2024, WHO invited manufacturers of mpox IVDs submit an expression of interest for EULrecognizing the urgent need to strengthen global testing capacity as the virus continues to spread. The EUL process assesses the quality, safety and efficacy of essential health products, such as diagnostic tests, to guide procuring agencies and WHO Member States in making informed decisions for time-limited emergency procurement.
To date, WHO has received three additional submissions for EUL evaluation, and discussions are ongoing with other manufacturers of mpox IVDs to provide a wider range of quality-assured diagnostic options. This will support countries that have not approved medical products through their own approval processes to procure critically needed tests through UN agencies and other procurement partners.
The EUL for the Alinity m MPXV test, which allows its use, will remain valid as long as the PHEIC, which justifies the emergency use of mpox in vitro diagnostics, is in place.
Information on active EUL applications for mpox IVDs can be found on these pages WHO website.
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Sources 2/ https://www.who.int/news/item/03-10-2024-who-approves-first-mpox-diagnostic-test-for-emergency-use–boosting-global-access The mention sources can contact us to remove/changing this article |
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