The World Health Organization (WHO) has approved the first test for the diagnosis of mpox under its Emergency Use Listing (EUL). Monkeypox, which has been declared a public health emergency, is a disease caused by the monkeypox virus that causes flu-like symptoms with skin rashes and blisters.

The in vitro diagnostic (IVD) MPOX test is called the Alinity M MPOXV assay developed by Abbott Molecular Inc.

The test has been approved for emergency use, an important development in increasing testing capacities in countries battling mpox outbreaks.

According to the official WHO report, the need for rapid and accurate mpox testing has increased, especially in areas such as Africa, where limited testing has contributed to the continued spread of the virus.

Early detection of mpox is important to provide timely treatment, manage outbreaks, and control the spread of the disease.

In 2024, more than 30,000 suspected mpox cases have been reported in Africa, with the highest numbers in the Democratic Republic of Congo, Burundi and Nigeria.

In the Democratic Republic of the Congo, only 37% of suspected cases have been tested so far this year, highlighting the urgency of better testing solutions.

How are diagnostic tests performed?

According to WHO guidelines, mpox is confirmed through nucleic acid amplification testing (NAAT) such as polymerase chain reaction (PCR) testing.

The most reliable samples for diagnosis come from skin lesions. The Alinity M MPXV assay is a real-time PCR test designed to detect monkeypox virus (clade I/II) in swabs of skin lesions.

It is to be used by trained laboratory personnel skilled in PCR techniques. By analyzing samples of skin rashes, health workers can efficiently confirm suspected Mpox cases, allowing rapid response and care.

“This is an important milestone in expanding testing in affected countries. Increasing access to quality testing is central to helping countries contain the virus and protect their populations, especially in underserved areas,” Dr. said Yukiko Nakatani, WHO’s assistant director-general for access. Medicines and health products.

WHO’s EUL process accelerates the availability of critical health products, including vaccines, tests and treatments, during global health emergencies.

In August 2024, WHO urged manufacturers of mpox diagnostic tests to submit products for evaluation under the EUL, as the need for global testing capacities continued to grow.

So far, WHO has received three more applications for EUL evaluation, and discussions are ongoing with other test manufacturers.

The Emergency Use Listing for the Alinity M MPXV assay will remain valid as long as the Public Health Emergency of International Concern (PHEIC) related to MPOX continues.