The Alinity m MPXV assay is a real-time PCR (polymerase chain reaction) test that allows the detection of monkeypox virus DNA from swabs of human skin lesions.
It is manufactured by Abbott Molecular Inc, a US company, and is designed specifically for use by trained clinical laboratory personnel.
'A significant milestone'
“This first mpox diagnostic test included in the Emergency Use Listing procedure represents an important milestone in expanding testing availability in affected countries”said Dr. Yukiko Nakatani, WHO Assistant Director-General for Access to Medicines and Health Products.
Detection of viral DNA using PCR testing is the gold standard for diagnosing mpox.
The WHO said early diagnosis is essential as it allows for timely treatment and care, as well as control of the virus.
Limited testing capacity and delays in confirming mox cases persist in Africa, contributing to the continued spread of the virus.
More than 30,000 suspected cases have been reported on the continent this year, with the highest numbers in the Democratic Republic of the Congo (DRC), Burundi and Nigeria. Furthermore, only 37 percent of suspected cases in the Democratic Republic of the Congo have been tested.
Global health emergency
Mpox, formerly known as monkeypox, is an infectious disease caused by the monkeypox virus (MPXV). Symptoms include painful rash, enlarged lymph nodes, fever, headache, and muscle pain.
A global outbreak first emerged in May 2022, which the WHO said constituted a public health emergency of international concern (PHEIC), the highest level of alarm under international health law.
Africa has seen an unprecedented rise and expansion in mpox cases this year, with transmission primarily centered in the Democratic Republic of the Congo. The increase is being driven by two mpox virus strains, or clades.
Following the rapid spread of the new virulent clade 1b strain, which has also been detected outside Africa, the WHO declared on August 14 that mpox was once again a PHEIC.
Emergency Use Listing
The WHO Emergency Use Listing (EUL) procedure accelerates the availability of life-saving medical products, such as vaccines, tests and treatments, in the context of a PHEIC.
On August 28, the UN agency asked manufacturers to submit an expression of interest for EUL, recognizing the urgent need to strengthen global testing capabilities as the virus continued to spread.
EUL is a risk-based procedure for evaluating the quality, safety and performance of unlicensed vaccines.in vitro therapeutics and diagnostics, to expedite their availability during public health emergencies.
So far, WHO has received three additional submissions for EUL evaluation and discussions are ongoing with other manufacturers.
