WHO Approves First Mpox Diagnostic Test for Emergency Use

In 2024 alone, more than 30,000 suspected cases have been reported across the region, with the highest numbers seen 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. The World Health Organization (WHO, Geneva, Switzerland) has now taken an important step to improve global access to mpox testing by listing the first mpox in vitro diagnostic (IVD) under its Emergency Use Listing (EUL) procedure.

The emergency use approval for the Alinity m MPXV assay, manufactured by Abbott Molecular Inc. (Abbott Park, IL, USA), is expected to significantly expand diagnostic capacity in countries experiencing mpox outbreaks, where the need for rapid and accurate testing has become urgent. Early detection of mpox is critical for timely treatment and virus control. The WHO Interim Guidance on Diagnostic Testing for the monkeypox virus (MPXV) states that nucleic acid amplification testing (NAAT), such as real-time or conventional polymerase chain reaction (PCR), is required to confirm the presence of the virus. Lesion material is the recommended specimen type for diagnostic confirmation of mpox infection. The Alinity m MPXV assay is a real-time PCR test designed to detect monkeypox virus (clade I/II) DNA from human skin lesion swabs. The test is intended for use by trained clinical laboratory personnel skilled in PCR techniques and IVD procedures. By detecting DNA from pustular or vesicular rash samples, the test enables laboratory and healthcare workers to confirm suspected mpox cases efficiently.

The EUL process is intended to accelerate the availability of life-saving medical products, including vaccines, tests, and treatments, in the context of a Public Health Emergency of International Concern (PHEIC). On August 28, 2024, WHO called on mpox IVD manufacturers to submit an expression of interest for EUL, recognizing the urgent need to strengthen global testing capacities as the virus continued to spread. The EUL process evaluates the quality, safety, and performance of critical health products, such as diagnostic tests, helping procurement agencies and WHO Member States make informed decisions for time-sensitive emergency purchases. So far, WHO has received three additional submissions for EUL evaluation, with ongoing discussions with other manufacturers to ensure a broader range of quality-assured diagnostic options. This will support countries without their own approval processes to procure essential tests through UN agencies and other procurement partners. The EUL for the Alinity m MPXV assay will remain valid as long as the PHEIC, which justifies the emergency use of mpox in vitro diagnostics, is in effect.

"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."

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