WHO approves first testing kit for mpox diagnosis

The first mpox testing kit has been approved by the World Health Organisation (WHO).

In Short

• The WHO has approved the first mpox testing kit for emergency diagnosis
• The mpox testing kit is called the Alinity m MPXV assay
• The most reliable samples for diagnosis come from skin lesions

The World Health Organisation (WHO) has approved the first test to diagnose mpox under its Emergency Use Listing (EUL). Mpox, which has been declared a public health emergency, is a disease caused by the monkeypox virus that leads to flu-like symptoms with skin rash and blisters.

The mpox testing in vitro diagnostic (IVD) is called the Alinity m MPXV assay, developed by Abbott Molecular Inc.

The test has been approved for emergency use, marking a crucial development in ramping up testing capabilities in countries battling mpox outbreaks.

The need for fast and accurate mpox testing has surged, especially in regions like Africa, where limited testing has contributed to the ongoing spread of the virus, as per the WHO's official report.

Early detection of mpox is important in providing timely treatment, managing outbreaks, and controlling the spread of the disease.

In 2024, over 30,000 suspected mpox cases have been reported in Africa, with the highest numbers 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 so far this year, highlighting the urgency for better testing solutions.

HOW IS THE DIAGNOSTIC TEST DONE?

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

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

It is meant to be used by trained lab personnel skilled in PCR techniques. By analysing skin rash samples, health workers can confirm suspected mpox cases efficiently, enabling quicker response and care.

"This is a significant 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," said Dr Yukiko Nakatani, WHO Assistant Director-General for Access to Medicines and Health Products.

The WHO's EUL procedure 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 assessment, 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.