WHO approves the first monkeypox diagnostic test for emergency use. All you need to know about the EUL process peppermint

The World Health Organization (WHO) has listed the first mPox in vitro diagnostic (IVD) under its Emergency Use Listing (EUL) process, an important advancement in increasing global access to mPox testing.

In an official statement, WHO said the emergency use approval for the Alinity M MPOXV assay, manufactured by Abbott Molecular Inc., is important in expanding diagnostic capacity in countries facing MPOX outbreaks, where rapid and accurate testing is needed. The need has increased rapidly.

Also read: First ‘suspected’ case of monkeypox reported in India, Center assures ‘no cause for undue concern’

What is the Emergency Use Listing (EUL) process?

The Alinity M MPXV assay is a real-time PCR test that enables 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 who are proficient in PCR techniques and IVD procedures.

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

Also read: Monkeypox is now a public health emergency of international concern. Know the causes, symptoms, treatment

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 had called on MPOX IVD manufacturers to submit expressions of interest for EUL, recognizing the urgent need to increase global testing capacities as the virus continues to spread.

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

Also read: Monkeypox: Key facts about monkeypox virus and how it spreads as WHO declares global health emergency

“This first mPox diagnostic test listed under the Emergency Use Listing procedure represents an important milestone in expanding testing availability in affected countries,” said Dr. Yukiko Nakatani, WHO Assistant Director-General for Access to Medicines and Health Products. “Ensure medical products are at the heart of our efforts to help countries stop the spread of the virus and protect their people, especially in disadvantaged areas.”

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

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

Also read: Could Mpox bring about another Covid-like pandemic? ‘We should be worried,’ experts say…

To date, WHO has received three additional submissions for emergency use listing (EUL) evaluation, and discussions are ongoing with other manufacturers of the MPOX IVD to provide a broader range of quality-assured clinical options. This effort aims to assist countries that have not yet approved these medical products through their processes, enabling them to obtain the necessary testing through UN agencies and other procurement partners.

WHO stated that 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 mPXV in in vitro diagnostics is in effect.