By Muhammad Amaan
World Health Organisation (WHO) has asked manufacturers of Mpox In Vitro Diagnostics (IVDs) to submit an expression of interest for Emergency Use Listing (EUL).
The organisation made the request on Thursday in a statement, adding that the global body had been discussing with manufacturers, about the need for effective diagnostics, particularly in low-income settings.
It stated that “we invite manufacturers to present request for EUL expression of interest in the latest discussion.”
According to it, testing is key for people to get treatment and care as early as possible and prevent further spread.
“Since 2022, WHO delivered around 150,000 diagnostic tests for Mpox globally, of which, more than a quarter were to countries in the African Region.
“In the coming weeks, WHO will deliver another 30,000 tests to African countries.
“With as many as 1000 suspected cases reported in the Democratic Republic of the Congo alone this week, the demand for diagnostic tests is on the rise,” it said.
It stated that in DR Congo, WHO worked with partners to scale up diagnostic capacity to respond to upsurge of cases.
It explained that since May, six additional labs were equipped to diagnose Mpox, enabling decentralisation of testing capacity from major cities to affected provinces.
“Two of these labs are in South Kivu, selected to respond to the outbreak of the new viral strain called Ib.
“Thanks to these efforts, as testing rates have dramatically improved in that country, with four times as many samples tested in 2024 so far compared to 2023.”
It said that WHO has updated its diagnostic testing guidance to detect the new virus strain and working with countries to roll it out.
The statement said that earlier, WHO issued target product profiles to guide manufacturers in the development of new diagnostic tests.
Dr Tedros Ghebreyesus, the WHO Director-General, declared the upsurge of Mpox in DR Congo on Aug. 14, saying it constitutes a Public Health Emergency of International Concern (PHEIC) under the International Health Regulations (2005).
He said that manufacturers of IVDs are to submit available quality, safety and performance data to WHO as soon as they can.
“IVDs are tests done in laboratories to detect a pathogen. Detection of viral DNA by PCR (Polymerase Chain Reaction) testing is the gold standard for Mpox diagnosis.
“It detects the virus’s DNA in samples taken from skin lesions, such as fluid or crusts from vesicles or pustules.
“Testing of blood is not recommended for routine diagnosis and antibody detection methods may be used for retrospective case classification but not for diagnosis,” the WHO boss said.
According to him, through the EUL procedure, WHO can approve medical products such as vaccines, tests and treatments for use, evaluating the acceptability of using specific products for time-limited procurement in emergency situations.
“The process aims to assist countries which have not approved the medical products through national approval processes to procure critically needed products such as tests through UN agencies and other partners.
“Mpox is an illness caused by the monkeypox virus, species of the genus orthopoxvirus, and can be transmitted to humans through contacts with someone who is infectious with contaminated materials, or with infected animals,” he said.
Ghebreyesus said expanding access to diagnostic services was urgently needed as tests were essential to critical measures such as strengthened laboratory capacity, improved case investigation, contact tracing, surveillance data collection and timely reporting.
“As a package, these can help countries to identify chains of transmission, detect cases early, prevent further spread and monitor the virus in real-time.
“The establishment of Emergency Use Listing procedures for Mpox diagnostic tests will help to advance toward this goal,” he said.
