WHO approves first emergency use diagnostic test for Mpox

CAIRO – 4 October 2024: The World Health Organization (WHO) announced today that it has approved the first emergency use diagnostic test for mpox (formerly known as monkeypox). This test will help expand access to regions affected by the virus globally.

The WHO has added the first in-vitro diagnostic (IVD) test for mpox to its Emergency Use Listing (EUL), a key step in improving global access to mpox testing. The test, Alinity m MPXV, manufactured by Abbott Molecular Inc, plays a crucial role in increasing diagnostic capabilities in countries facing mpox outbreaks, where there is an urgent need for rapid and accurate testing.

Early diagnosis of mpox enables timely treatment, care, and virus containment. However, testing capacity remains limited, and there are delays in confirming mpox cases in Africa, contributing to the virus’s continued spread.

In 2024, over 30,000 suspected mpox cases have been reported across the region, with the highest numbers in the Democratic Republic of Congo (DRC), Burundi, and Nigeria. In the DRC, only 37% of suspected cases have been tested this year.

The detection of mpox is confirmed through nucleic acid amplification testing (NAAT), such as real-time or traditional polymerase chain reaction (PCR), as stated in WHO's interim guidance on mpox diagnostics. The recommended sample type for mpox confirmation in suspected cases is lesion material.

The Alinity m MPXV test is a real-time PCR test designed to detect mpox DNA from human skin lesion swabs (both clade I and clade II). It is intended for use by trained laboratory staff skilled in PCR techniques and laboratory diagnostics. By detecting DNA from pustular or vesicular skin lesions, lab workers can efficiently confirm suspected mpox cases.

Critical Step in Mpox Response

Dr. Yukiko Nakatani, WHO’s Assistant Director-General for Access to Medicines and Health Products, highlighted the significance of this diagnostic test, stating, “This is the first diagnostic test to be included on the EUL and is a major achievement in expanding access to testing in affected countries.” She emphasized that expanding access to high-quality medical products is vital to efforts to help countries contain the virus and protect their populations, particularly in underserved regions.

The Emergency Use Listing (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 (PHEIC).

On August 28, 2024, WHO urged manufacturers of mpox diagnostic devices to submit their applications for EUL approval, acknowledging the critical need to enhance global testing capabilities as the virus continues to spread.

The EUL process evaluates the quality, safety, and performance of essential health products like diagnostic tests, providing guidance to procurement agencies and WHO member states for informed decision-making in time-sensitive emergency purchases.

To date, WHO has received three additional applications for evaluation and is in talks with other manufacturers of mpox IVDs to ensure a broader range of quality-assured diagnostic options.

This approval will support countries without their own medical product approval processes to purchase the much-needed tests through United Nations agencies and other procurement partners.

The EUL license for the Alinity m MPXV mpox diagnostic test will remain valid as long as the PHEIC remains in effect, justifying the emergency use of mpox diagnostic tests.