Mpox Diagnosis: WHO Approves First Testing Kit; Here Are Details

New Delhi: The World Health Organisation (WHO) has approved the first testing kit to diagnose Mpox under its Emergency Use Listing (EUL).

Developed by Abbott Molecular Inc, the in-vitro diagnostic (IVD) Mpox testing is called Alinity m MPXV assay.

The test, approved for emergency use, will help in ramping up testing capabilities in countries which are battling Mpox outbreaks.

Africa is the worst hit, while some stray cases have been detected in India, Pakistan and some European nations as well.

Declared a public health emergency by WHO in August, Mpox is a viral disease that leads to flu-like symptoms with skin rash and blisters.

Early detection of Mpox will help provide timely treatment, manage outbreaks and control the spread of the disease.

Only 37% of suspected cases in Democratic Republic of Congo – the latest hotbed of the disease — have been tested so far this year, hence availability of the testing kit will be of immense help.

As per WHO guidelines, Mpox is confirmed through nucleic acid amplification testing (NAAT), such as polymerase chain reaction (PCR) testing, with skin lesions being the most reliable samples for diagnosis.

The Alinity m MPXV assay is a real-time PCR test designed to detect Mpox virus (clades I/II) in skin lesion swabs.

“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.