WHO approves first monkeypox diagnostic test for emergency use. All you need to know about EUL procedure | Mint

The World Health Organization (WHO) has listed the first mpox in vitro diagnostic (IVD) under its Emergency Use Listing (EUL) procedure, marking a significant advancement in enhancing global access to mpox testing.

In an official statement, WHO said that the emergency use approval for the Alinity m MPXV assay, produced by Abbott Molecular Inc., pivotal in expanding diagnostic capacity in countries facing mpox outbreaks, where the need for quick and accurate testing has risen sharply.

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What is Emergency Use Listing (EUL) procedure?

The Alinity m MPXV assay is a real-time PCR test that enables detection of monkeypox virus (clade I/II) DNA from human skin lesion swabs. It is specifically designed for use by trained clinical laboratory personnel who are proficient in PCR techniques and IVD procedures.

“By detecting DNA from pustular or vesicular rash samples, laboratory and health workers can confirm suspected mpox cases efficiently and effectively,” said WHO.

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The EUL process accelerates the availability of life-saving medical products, such as vaccines, tests and treatments, in the context of a Public Health Emergency of International Concern (PHEIC).

Earlier on 28 August 2024, WHO called on mpox IVDs manufacturers to submit an expression of interest for EUL, recognizing the urgent need to bolster global testing capacities as the virus continued to spread.

Moreover, the EUL process assesses the quality, safety, and performance of essential health products, such as diagnostic tests, to guide procurement agencies and WHO Member States in making informed decisions for time-limited emergency procurement.

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“This first mpox diagnostic test listed under the Emergency Use Listing procedure represents a significant milestone in expanding testing availability in affected countries,” said Dr Yukiko Nakatani, WHO Assistant Director-General for Access to Medicines and Health Products. “Increasing access to quality-assured medical products is central to our efforts in assisting countries to contain the spread of the virus and protect their people, especially in underserved regions.”

Early diagnosis of mpox facilitates timely treatment and care, helping to control the virus, WHO noted.

Limited testing capacity and delays in confirming mpox cases persist in Africa, contributing to the continued spread of the virus. In 2024, over 30 000 suspected cases have been reported across the region, with the highest numbers in the Democratic Republic of the Congo, Burundi, and Nigeria. In the Democratic Republic of the Congo, only 37% of suspected cases have been tested this year.

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So far, the WHO has received three additional submissions for Emergency Use Listing (EUL) evaluation, and discussions are underway with other manufacturers of mpox IVDs to provide a broader range of quality-assured diagnostic options. This effort aims to assist countries that have not yet approved these medical products through their own processes, enabling them to obtain essential tests via UN agencies and other procurement partners.

The EUL for the Alinity m MPXV assay will remain valid as long as the Public Health Emergency of International Concern (PHEIC) justifying the emergency use of mpox in vitro diagnostics is in effect, said WHO.