Grapevine

WHO approves first mpox diagnostic test for emergency use

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.”