WHO approves first mpox diagnostic test for emergency use
The Alinity m MPXV test is a real-time PCR (polymerase chain reaction) test that allows the detection of monkeypox virus DNA from human skin lesion specimens.
It is manufactured by Abbott Molecular Inc, an American company, and is specifically designed for use by trained clinical laboratory personnel.
‘An important milestone’
“This first mpox diagnostic test is listed under the Emergency Use Listing protocol marks an important milestone in expanding testing capacity in affected countries,” speak Dr. Yukiko Nakatani, WHO Assistant Director General for Access to Medicines and Health Products.
The detection of viral DNA by PCR testing is gold standard to diagnose mpox.
WHO says early diagnosis is important because it allows for timely treatment and care as well as control of the virus.
Limited testing capacity and delays in confirming cases of mpox infection 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 Congo (DRC), Burundi and Nigeria. Furthermore, only 37% of suspected cases in DRC have been tested.
Global medical emergency
Mpox, formerly known as monkeypox, is an infectious disease caused by the monkeypox virus (MPXV). Symptoms include a painful rash, lymphadenopathy, fever, headache and muscle pain.
A global outbreak first emerged in May 2022 that WHO said constituted a public health emergency of international concern (PHEIC) – the highest level of alert under health law international.
Africa has seen an unprecedented rise and expansion in the number of mpox cases this year, with transmission mainly concentrated in the DRC. This increase is driven by two strains or lineages of mpox virus.
Following the rapid spread of the new virulent 1b strain, which has also been detected outside Africa, WHO on 14 August declare That mpox is again PHEIC.
Emergency use list
The WHO Emergency Use Listing (EUL) process helps speed up the availability of life-saving medical products, such as vaccines, tests and treatments, in the context of PHEIC.
On August 28, the United Nations agency called on manufacturersto submit an expression of interest to EULrecognizes the urgent need to increase global testing capacity as the virus continues to spread.
EUL is a risk-based process for assessing the quality, safety and effectiveness of unlicensed vaccinestherapeutics and in vitro diagnostics, to accelerate their availability during public health emergencies.
To date, WHO has received three further submissions for EUL assessment and discussions are ongoing with other manufacturers.
