The ‘real time PCR test’ will enable the detection of the virus by swabbing human skin lesions.
The World Health Organization (WHO) has approved the use of the first diagnostic test for mpox that will provide immediate results. This will increase testing capabilities in countries facing outbreaks, it says.
The WHO announced on Friday that it had approved the “real-time PCR test”, Alinity m MPXV assay, which enables the detection of the virus by testing swabs of skin lesions.
Currently, patients have to wait days for results. This test will help health workers confirm suspected cases more “efficiently”, the WHO said.
In the Democratic Republic of the Congo (DRC), the epicentre of the current outbreak, only 37 percent of suspected cases have been tested this year, the United Nations health agency noted.
This test’s approval “will be pivotal in expanding diagnostic capacity in countries facing mpox outbreaks, where the need for quick and accurate testing has risen sharply,” it added in a statement.
Mpox, which is transmitted by human-to-human contact and contact with infected animals, has been detected in 16 African countries this year.
According to the African Union’s Centres for Disease Control and Prevention, more than 800 people across the continent have died from the disease, which causes fever, aches and skin lesions.
“By detecting DNA from pustular or vesicular rash samples, laboratory and health workers can confirm suspected mpox cases efficiently and effectively,” the WHO said.
“Limited testing capacity and delays in confirming mpox cases persist in Africa, contributing to the continued spread of the virus,” it added.
‘Protecting people in underserved regions’
“This first mpox diagnostic test listed under the Emergency Use Listing (EUL) procedure represents a significant milestone in expanding testing availability in affected countries,” said Yukiko Nakatani, the WHO’s assistant director-general for access to medicines and health products.
The agency said it was evaluating three new mpox diagnostic tests for emergency use and was also in discussions with other manufacturers to expand the availability of mpox diagnostic tools.
In August, after the WHO declared mpox a global public health emergency for the second time in two years, it asked manufacturers to submit their products for an emergency review.
The EUL procedure is a risk-based assessment of unlicensed vaccines, tests and treatments to expedite their availability during public health emergencies.
Nakatani explained that the approval of the test increases “access to quality-assured medical products” and “is central to our efforts in assisting countries to contain the spread of the virus and protect their people, especially in underserved regions”.
The latest mpox outbreak began in the DRC and later spread to neighbouring countries, including Burundi, Uganda and Rwanda.
So far, two strains of the virus are spreading: the clade 1 variant, which is endemic in parts of West and Central Africa, and clade 1b, a new, more infectious variant that has triggered international concern.
India, Thailand and Sweden have all reported cases of the clade 1b variant of mpox.