NEW DELHI: The World Health Organization (WHO) has approved the first Mpox diagnostic test for emergency use for early diagnosis to enable timely treatment, care, and virus control.
WHO approved the first Mpox in vitro diagnostic (IVD) under its Emergency Use Listing (EUL) procedure, an important step in improving global access to Mpox testing.
The approval for emergency use was given to Abbott Molecular Inc. PCR test, Alinity m MPXV assay. The WHO said the test would be pivotal in expanding diagnostic capacity in countries facing Mpox outbreaks, where the need for quick and accurate testing has risen sharply.
The Alinity m MPXV assay is a real-time PCR test that detects monkeypox virus (clade I/II) DNA in human skin lesion swabs.
"It is specifically designed for use by trained clinical laboratory personnel proficient in PCR techniques and IVD procedures. By detecting DNA from pustular or vesicular rash samples, laboratory and health workers can confirm suspected Mpox cases efficiently and effectively," the WHO said.
"This first mpox diagnostic test listed under the Emergency Use Listing procedure represents a significant milestone in expanding testing availability in affected countries," said Dr Yukiko Nakatani, WHO Assistant Director-General for Access to Medicines and Health Products.
"Increasing access to quality-assured medical products is central to our efforts in assisting countries to contain the spread of the virus and protect their people, especially in underserved regions."
On August 14, the WHO declared mpox a global public health emergency for the second time in two years. The announcement came following an outbreak of the viral infection in the Democratic Republic of Congo that is fast spreading in neighbouring African countries.
Outside Africa, one case each of mpox clade 1b has been recently reported from Sweden and Thailand. India is the third country to report this fast-spreading Mpox strain. Kerala reported its first case of Mpox clade 1b.
According to WHO, limited testing capacity and delays in confirming mpox cases persist in Africa, contributing to the continued spread of the virus.
In 2024, over 30,000 suspected cases were reported across the region, with the highest numbers in the Democratic Republic of the Congo, Burundi, and Nigeria. However, only 37% of suspected cases have been tested in the Democratic Republic of the Congo this year.
The presence of the monkeypox virus is confirmed by nucleic acid amplification testing (NAAT), such as real-time or conventional polymerase chain reaction (PCR), as stated in the WHO Interim Guidance on Diagnostic testing for the monkeypox virus (MPXV).
Lesion material is the recommended specimen type for diagnosing and confirming monkeypox virus (MPXV) infection in suspected cases.
The EUL process accelerates the availability of life-saving medical products, such as vaccines, tests, and treatments, in the context of a Public Health Emergency of International Concern (PHEIC).
On August 28, WHO called on Mpox IVD manufacturers to submit an expression of interest for EUL, recognizing the urgent need to bolster global testing capacities as the virus spread.
The EUL process assesses essential health products' quality, safety, and performance, such as diagnostic tests, to guide procurement agencies and WHO Member States in making informed decisions for time-limited emergency procurement.
So far, WHO has received three additional submissions for EUL evaluation, and discussions are ongoing with other manufacturers of Mpox IVDs to ensure a wider range of quality-assured diagnostic options.
This will support countries that have yet to approve the medical products through their approval processes to procure the critically needed tests through UN agencies and other procurement partners.
The EUL for the Alinity m MPXV assay, allowing its use, will remain valid as long as the PHEIC, justifying the emergency use of MPox in vitro diagnostics, is in effect.