The WHO has approved the first monkeypox diagnostic test under its Emergency Use Listing (EUL), the Alinity m MPXV assay. This PCR test enhances global mpox testing capacity, enabling quicker detection and response to outbreaks. Learn more about the EUL procedure and its impact on public health.
The World Health Organization has just given its nod to the very first in-vitro diagnostic meant for emergency use concerning the testing against mpox or popularly known as monkeypox. The test is known as the Alinity m MPXV assay and was developed by Abbott Molecular Inc. It detects the presence of the monkeypox virus from the swabs of human skin lesion. This approval has lots of promise in bringing about the wars over mpox outbreaks worldwide.
What is the Alinity m MPXV Assay?
The Alinity m MPXV assay is designed as a real-time PCR that would allow healthcare professionals to identify the monkeypox virus-clade I/II-by way of DNA preparation from samples that show pustular or vesicular rash. The test is intended for use by trained laboratory personnel proficient in PCR techniques. With recent outbreaks across the globe about mpox causing much concern, this diagnostic tool will help much in bringing out timely diagnoses and treatment.
It will be part of WHO’s EUL process and will be useful especially at the time of peak cases of mpox in the countries where testing or diagnostic accuracy would be drastically crucial in time.
The test will attempt to help the healthcare workers to verify the suspected cases effectively in an attempt to contain the spread of the virus.
Understanding the EUL Procedure
The EUL procedure is an expedited regulatory process for the availability of essential medical products, such as diagnostic tests, vaccines, and treatments, during public health emergencies. It is basically letting quality, safety, and performance evaluation take place quickly by making these products available when otherwise longer traditional approval processes would delay access to them.
In the case of mpox, WHO’s approval of the Alinity m MPXV assay through the EUL procedure comes at a particularly critical time, as countries around the world seek to expand their diagnostic capacities to manage outbreaks. Listing helps guide procurement agencies and WHO member states, so they can make better decisions for emergency purchases and deployment of these life-saving health products.
Why Alinity m MPXV Assay is Important for Mpox Control
In contemporary times, where the mpox has been highly spread in most parts of the world, speeding testing has been at the center of containing its further spread. According to WHO, early diagnosis of mpox results in timely treatment and care, thus contributing to controlling the virus. This delay in confirmation of mpox cases means that many of them continue to spread the virus in places where testing capacity is still very low, especially in Africa. Already, more than 30,000 suspected cases of mpox have been reported this year alone in the continent, with major outbreaks being reported in countries such as the Democratic Republic of the Congo, Burundi, and Nigeria.
One of the key challenges has been a low testing rate. In the Democratic Republic of the Congo, for example, only 37% of the suspected cases have been tested so far this year. Licensure of the Alinity m MPXV assay will help bridge the gap given the need for reliable and rapid diagnostics.
WHO Urges Increased Mpox Testing
The Alinity m MPXV assay has been approved by WHO following the latter’s publication of a call inviting manufacturers of mpox IVDs to submit expressions of interest for EUL. The WHO also made an urgent statement in August 2024, calling upon manufacturers to accelerate the development and provision of additional tools for the diagnosis of mpox globally.
According to Dr. Yukiko Nakatani, WHO Assistant Director-General for Access to Medicines and Health Products, such developments will be very important as they “increase access to quality-assured medical products central to our efforts in assisting countries to contain the spread of the virus and protect their people, especially in underserved regions.”.
In fact, WHO has received the third round of additional applications to be evaluated for EUL and is in dialogue with other producers to make even more tests available. This is very important for countries that don’t have an approval process within their countries in respect of mpox diagnostics because those countries will now be able to acquire the tests through UN agencies and other global partners.
Impact International Level of EUL Approval
Having settled the approval of the Alinity m MPXV assay, currently afflicted nations in mpox outbreaks may then gain a validated and workable testing solution. The test shall be retained as long as the PHEIC status of mpox is extant. Such tests’ distribution must provide for quick, accurate results that can lead to treatment and containment interventions.
In addition to the improvement of case management, the WHO also views an opportunity for employment production regarding preserving, documenting, and digitizing the medical research. The development of diagnostic tools and expansion of testing infrastructure might open up employment opportunities in archiving, publishing, and digital media.
The WHO approval of Alinity m MPXV assay for emergency use is a critical step in the fight against mpox because it is among the first diagnostic tests listed under the Emergency Use Listing process. This in turn marks an important step forward in expanding testing capacity across the globe. This will help those countries in managing and controlling the spread of the monkeypox virus through this timely and accurate detection capability. With more additional diagnostic tools to soon be deployed, the global response for outbreaks of mpox is about to improve significantly.
