WHO puts two new diagnostic tests for mpox on its urgent action list

The World Health Organization (WHO) has included in this environment two other in vitro diagnoses (IVD) of smallpox, formerly known as monkeypox, in the Emergency Use Listing (EUL) procedure, with both tests being polymerase chain reaction (PCR) tests that detect viral DNA and are considered the “reference” method for performing diagnosis of this disease.

One of them is ‘Expert Mpox‘, production Seheid based on emergency use listing procedures, which is an “easy-to-use” test with results available in less than 40 minutes.

“Ensuring global access to mpox diagnostic tests that meet WHO standards for quality, safety and efficacy is essential for efficient and effective testing in settings affected by mpox outbreaks.”

“Once the cartridge is placed in the system, the process is fully automated, Real-time PCR which detects monkeypox virus clade II viral DNA. The GeneXpert system that powers this test is a test option that can be performed virtually at the point of care, allowing decentralized testing,” WHO said in a statement.

The body has also approved the test.”Kobas MPXV‘, developed by the company Roche Molecular SystemsIt is capable of detecting mpox clades and providing results in less than two hours, and can process multiple samples simultaneously, making it a “suitable” procedure for high-volume clinical laboratories.

“Ensure global access to appropriate mpox diagnostic tests WHO Quality, Safety and Efficacy Standards is essential for efficient and effective testing in settings affected by smallpox outbreaks,” said WHO Director of Regulatory and Prequalification Dr. Roger Gaspard.

In this sense, he explained that quick access The products included in this list are “essential” for both “rapid” diagnosis, “timely” treatment and even effective containment of the virus.

In August, the WHO declared a “public health emergency of international concern” due to the growing spread of smallpox in Africa.

In early October, WHO included a studyAlinity m MPXV‘, from Abbott Molecularas the first in vitro diagnosis (IVD) of MPox within the EUL procedure. In August, WHO announced “public health emergency of international importance” due to the increasing spread of MPOX in Africa. This virus is transmitted mainly during close skin-to-skin contactfor example, during sexual relations or intimate hugs, massages and kisses.

Almost twenty countries have notified this during 2024. more than 40,000 cases of suspected mpoxmost of them are unconfirmed due to limited analytical capabilities low and middle income countriessuch as the Democratic Republic of the Congo (DRC), the worst affected country in the world, where only about half of the suspected cases have been analyzed.