Approval for emergency use of the Alinity m MPXV test, manufactured by Abbott Molecular Inc., will be instrumental in expanding diagnostic capacity in countries facing mpox outbreaks, according to the global health agency. where the need for rapid and accurate testing has greatly increased.
Increasing access to quality medical products is essential to help countries contain the spread of the virus and protect their populations
“This first smallpox diagnostic test on the emergency medicine list represents an important step in expanding the availability of tests in affected countries,” said Dr. Yukiko Nakatani, Assistant Director-General of the WHO for access to medicines and health products.
“Increasing access to quality medical products is essential to help countries contain the spread of the virus and protect their populations, especially in underserved regions,” she added.
The benefits of early diagnosis
Early diagnosis of smallpox allows for timely treatment and care and control of the virus.
Limited testing capacity and delays in confirming cases of mpox persist in Africa, contributing to the continued spread of the virus.
In 2024, more than 30,000 suspected cases have been reported in the region, with the highest numbers being in the Democratic Republic of Congo, Burundi and Nigeria. In the Democratic Republic of Congo, only 37% of suspected cases have been tested this year.
How the test works
The presence of mpox virus is confirmed by a nucleic acid amplification test, such as real-time or conventional polymerase chain reaction (PCR), as outlined in the WHO interim guidelines on mpox virus (MPXV) diagnostic tests.
The recommended sample type for diagnostic confirmation of virus infection in suspected cases is lesion material.
The Alinity m MPXV test is a real-time PCR test that detects mpox virus (clade I/II) DNA from human skin lesion swabs. It is specifically designed for use by trained clinical laboratory personnel proficient in PCR techniques and in vitro diagnostic procedures.
By detecting DNA from samples of pustular or vesicular rashes, laboratories and health workers can confirm suspected cases of smallpox effectively and efficiently.
Increasing access through universal licensing
The universal licensing 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.
On August 28, 2024, WHO called on manufacturers of mpox in vitro diagnostics to submit an expression of interest, recognizing the urgent need to strengthen global testing capacities as the virus continues to spread.
The end-user licensing process assesses the quality, safety and performance of essential health products, such as diagnostic tests, to help purchasing agencies and WHO Member States make decisions. informed decisions for time-limited emergency purchases.
So far, WHO has received three additional submissions, and discussions are ongoing with other manufacturers to ensure a wider range of quality-assured diagnostic options. This will allow countries that have not approved medical products through their own approval process to procure much-needed tests through UN agencies and other procurement partners.
In the DRC, decentralization of laboratories for rapid detection
The Democratic Republic of Congo (DRC) aims to decentralize laboratory services to improve access to diagnostics, reduce sample processing times and increase capacity for rapid response to epidemics such as the current mpox
Furthermore, WHO reports that in the Democratic Republic of Congo (DRC) efforts to improve access to mpox diagnosis include the decentralization of laboratory services. This country accounts for 90% of all cases of mpox recorded in the African region, with more than 30,600 suspected cases and 988 deaths reported as of September 26.
“The concrete benefits of laboratory decentralization are improved access to diagnostics, reduced sample processing times and increased capacity for rapid response to epidemics such as mpox currently,” explains Dr. Nicole Kumbolani Afuwa, head of the Provincial Health Division of the Equateur province.
Only 36% of suspected mpox cases were tested
From January to August 2024, only 36% of suspected mpox cases were tested in the country. Of the 370 existing GeneXpert devices in the country’s 26 provinces, only 240 were functional and served 329 out of 579 health zones, thus limiting the country’s diagnostic capabilities.
Last August, eight additional laboratories were installed to test mpox samples in five provinces, targeting eight localities (Mbandaka, Ingende, Goma, Bukavu, Kamituga, Kisangani, Boende and Kinshasa).
This decentralization of laboratories is fundamental to confirm cases more quickly, trigger response measures as soon as possible, including ensuring appropriate treatment for patients.
WHO supports the country in the implementation of the national preparedness and response plan, including strengthening surveillance and diagnostic capacities, contact tracing, provision of essential medicines for treatment, provision equipment for infection prevention and control, preparation for vaccine introduction, risk communication and community engagement and combating misinformation.
“We rely on the work of emergency teams to monitor cases, and we use the medicines and medical supplies received on a daily basis to treat patients and protect front-line health personnel. All this allows us to better care for patients with mpox and we remain hopeful of containing this disease very soon,” shared Brigitte Elema Tondoko, responsible for supervision at the mpox treatment center of the general reference hospital. from Wangata, to Mbandaka.
