WHO approves first mpox diagnostic test for emergency use

The World Health Organisation has listed the first mpox in vitro diagnostic test under its Emergency Use Listing procedure, marking an important step in improving global access to mpox testing.

In a statement released on Thursday, WHO announced that the emergency use approval of the Alinity m MPXV assay, manufactured by Abbott Molecular Inc., will be crucial in expanding diagnostic capacity in countries experiencing mpox outbreaks, where the demand for rapid and accurate testing has significantly increased.

The global health body noted that early diagnosis of mpox enables timely treatment, care, and control of the virus.

“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 per cent of suspected cases have been tested this year.”

According to WHO’s Interim Guidance on Diagnostic Testing for the Mpox Virus, confirmation of the virus is achieved through Nucleic Acid Amplification Testing, such as real-time or conventional Polymerase Chain Reaction (PCR), with lesion material being the recommended specimen type for diagnosis.

The Alinity m MPXV assay is a real-time PCR test designed to detect the monkeypox virus (clade I/II) DNA from human skin lesion swabs. It is intended for use by trained clinical laboratory personnel proficient in PCR techniques and in vitro diagnostic (IVD) procedures. By detecting DNA from pustular or vesicular rash samples, health workers can confirm suspected mpox cases efficiently and effectively.

“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 to help countries contain the spread of the virus and protect their populations, especially in underserved regions.”

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

On 28 August 2024, WHO invited manufacturers of mpox IVDs to submit expressions of interest for EUL, recognising the urgent need to strengthen global testing capacities as the virus continues to spread.

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 emergency procurement.

“So far, WHO has received three additional submissions for EUL evaluation, and discussions are ongoing with other manufacturers of mpox IVDs to ensure a wider range of quality-assured diagnostic options.

“This will support countries that have not approved these medical products through their own regulatory processes, enabling them to procure the critically needed tests through UN agencies and other procurement partners.

“The EUL for the Alinity m MPXV assay will remain valid as long as the PHEIC, justifying the emergency use of mpox in vitro diagnostics, is in effect,” the statement added.