WHO approves first monkeypox diagnostic test for emergency use. Everything you need to know about the EUL procedure

The World Health Organization (WHO) has included the first mox in vitro diagnostic (IVD) under its Emergency Use Listing (EUL) procedure, marking significant progress in improving global access to mpox testing.

In an official statement, WHO said emergency use approval for the Alinity m MPXV assay, produced by Abbott Molecular Inc., is critical to expanding diagnostic capacity in countries facing mpox outbreaks, where the need for testing fast and accurate has increased considerably.

Also read: India reports first ‘suspected’ case of monkeypox, Center says ‘no cause for undue concern’

What is the Emergency Use Listing (EUL) procedure?

The Alinity m MPXV assay is a real-time PCR test that allows the detection of monkeypox virus (clade I/II) DNA from swabs of human skin lesions. 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 healthcare workers can confirm suspected cases of mox efficiently and effectively,” the WHO stated.

Also read: Monkeypox is now a public health emergency of international concern | Know 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).

Previously, on August 28, 2024, WHO asked mpox IVD manufacturers to submit an expression of interest for EUL, recognizing the urgent need to bolster global testing capabilities as the virus continued to spread.

Additionally, the EUL process evaluates 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-sensitive emergency procurement. limited.

Also read: Mpox: Key facts about the monkeypox virus and how it is transmitted as WHO declares a global health emergency

“This first mpox diagnostic test included in the Emergency Use Listing procedure represents an important milestone in expanding testing availability in affected countries,” said Dr. Yukiko Nakatani, Deputy Director General for Access to Medicines and WHO Health Products. “Guaranteed medical products are critical to our efforts to help countries contain the spread of the virus and protect their people, especially in underserved regions.”

Early diagnosis of mpox facilitates timely treatment and care, which helps control the virus, the WHO said.

Limited testing capacity and delays in confirming mox 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 the Congo, only 37% of suspected cases have been tested this year.

Also read: Can Mpox bring another Covid-like pandemic? Experts say: “We should worry…”

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

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