young man shows his hands during a monkeypox outbreak in the Democratic Republic of the Congo

The World Health Organization announced Friday that it has granted emergency use listing for a monkeypox diagnostic reagent produced by Abbott Pharmaceuticals Inc. of United States, the first in vitro diagnostic for monkeypox approved by WHO. This helps countries with monkeypox outbreaks diagnose cases early and accurately, and is essential for timely treatment, care, and containment of the spread of the monkeypox virus.

According to WHO, the approved reagent (Alinity m MPXV) is a real-time polymerase chain reaction (PCR) test in which a patient is swabbed from a skin wound by trained clinical inspectors and DNA is detected in a sample of a pustular or vesicular rash by real-time polymerase chain reaction (RTR) for a rapid and effective diagnosis of suspected monkeypox cases.

The need for fast, accurate testing is growing

WHO noted that limited testing capacity in the African region and delays in confirming monkeypox cases have led to the spread of the virus. In 2024, more than 30,000 suspected cases of monkeypox were reported in the African region, with the highest numbers in the Democratic Republic of the Congo, Burundi and Nigeria. In the Democratic Republic of the Congo, however, only 37% of suspected cases have been tested for the monkeypox virus this year.

Yuko Nakatani, WHO's Assistant Director-General for Access to Medicines and Health Products, said the inclusion of the first monkeypox diagnostic in the emergency use listing is a key step in expanding testing capacity in affected countries.

"This will help improve countries' ability to access reliable quality medical products, especially in areas where medical resources are scarce, so that they can more effectively control the spread of the virus and protect people's health," she said. ”

Emergency Use List

The Emergency Use Listing process is designed to accelerate the availability of medical products such as vaccines, tests and therapeutics in international public health emergencies, and to help procuring agencies and WHO Member States make informed procurement decisions in emergency situations by assessing the quality, safety and performance of medical products.

On 28 August, WHO stressed the urgent need to build up global testing capacity as the virus continues to spread, calling on manufacturers of monkeypox in vitro diagnostics to submit applications for emergency use listing.

To date, WHO has received three additional emergency use applications and is in discussions with additional manufacturers of in vitro diagnostics for monkeypox to ensure that more quality-certified diagnostics are available.