The Alinity m MPXV test is a real-time PCR (polymerase chain reaction) test that can detect monkeypox virus DNA from swabs of human skin lesions.
It is manufactured by Abbott Molecular Inc, an American company, and designed specifically for use by trained clinical laboratory personnel.
‘An important milestone’
“This first mpox diagnostic test listed under the Emergency Use Listing procedure represents an important milestone in expanding the availability of testing in affected countries,” said Dr. Yukiko Nakatani, WHO Deputy Director General for Access to Medicines and Health Products.
Detection of viral DNA through PCR testing is the gold standard for mpox diagnosis.
The WHO said early diagnosis is crucial as it allows timely treatment and care, as well as control of the virus.
In Africa, limited testing capacity and delays in confirming MPOX cases persist, 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 percent of suspected cases in the DRC have been tested.
Global health crisis
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 aches.
In May 2022, the first global outbreak occurred, which WHO declared a public health emergency of international concern (PHEIC) – the highest alert level under international health law.
Africa has seen an unprecedented increase and expansion in MPOX cases this year, with transmission mainly occurring in the Democratic Republic of Congo. The wave is caused by two strains of the mpox virus, or clades.
Following the rapid spread of the new virulent clade 1b strain, which has also been found outside Africa, the WHO announced on August 14 declared that mpox was a PHEIC again.
Emergency use list
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 appealed to manufacturers to submit an expression of interest to EULrecognizing the urgent need to strengthen global testing capabilities as the virus continued to spread.
EUL is a risk-based procedure for assessing the quality, safety and performance of unlicensed vaccinestherapies and in vitro diagnostics, to expedite their availability during public health emergencies.
To date, WHO has received three additional submissions for EUL evaluation, and discussions are ongoing with other manufacturers.