WHO approves first Mpox diagnostic test for emergency use, boosting global access

The World Health Organization headquarters in Geneva, Switzerland. File
| Photo Credit: AP

In an important move to improve global access to Mpox testing, the World Health Organization (WHO) has listed the first Mpox in vitro diagnostic under its Emergency Use Listing procedure.

“The approval for emergency use of the Alinity m MPXV assay, manufactured by Abbott Molecular Inc, will be pivotal in expanding diagnostic capacity in countries facing Mpox outbreaks, where the need for quick and accurate testing has risen sharply. Early diagnosis of Mpox enables timely treatment and care, and control of the virus,’’ WHO said in a statement on Thursday (October 3, 2024).

Currently, 35 laboratories across India are equipped to test suspected cases of Mpox. In mid-August 2024, the WHO declared the surge of Mpox cases in several parts of Africa as a public health emergency of international concern. In India, 30 Mpox cases have been reported since the WHO’s declaration.

Limited testing capacity

The latest WHO statement added that 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 were reported across the region.

The presence of the monkeypox virus is confirmed by nucleic acid amplification testing, such as a real-time or conventional polymerase chain reaction (PCR), according to the WHO’s interim guidance on diagnostic testing for the monkeypox virus (MPXV). The recommended specimen type for diagnostic confirmation of an MPXV infection in suspected cases is lesion material.

The Alinity m MPXV assay is a real-time PCR test that enables 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 in vitro diagnostic procedures. By detecting DNA from pustular or vesicular rash samples, laboratory and health workers can confirm suspected Mpox cases efficiently and effectively.

Expanding availability

“This first Mpox diagnostic test listed under the Emergency Use Listing (EUL) procedure represents a significant milestone in expanding testing availability in affected countries,” said Yukiko Nakatani, WHO’s 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,” Dr. Nakatani added.

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.