SWITZERLAND—The World Health Organization (WHO) has listed the first in vitro diagnostic (IVD) for the Mpox virus under its Emergency Use Listing (EUL) procedure.
This diagnostic, known as the Alinity m MPXV assay, is manufactured by Abbott Molecular Inc. and is expected to play a crucial role in expanding testing capacity in countries grappling with mpox outbreaks, where the demand for rapid and accurate testing has surged.
The timely identification of mpox cases is essential for ensuring prompt treatment and care, as well as for controlling the spread of the virus.
However, testing limitations and delays continue to hinder effective diagnosis, particularly in Africa. This has contributed to the ongoing transmission of mpox in several regions.
In 2024 alone, more than 30,000 suspected cases have been reported, with the highest numbers recorded in the Democratic Republic of the Congo, Burundi, and Nigeria.
Alarmingly, in the Democratic Republic of the Congo, only 37% of suspected cases have been tested so far this year.
According to WHO’s Interim Guidance on Diagnostic Testing for the Monkeypox Virus (MPXV), nucleic acid amplification testing (NAAT), such as real-time or conventional polymerase chain reaction (PCR), is the recommended method for confirming the presence of the virus.
Specifically, lesion material from suspected cases is identified as the preferred specimen type for diagnostic confirmation.
The Alinity m MPXV assay is a real-time PCR test designed to detect monkeypox virus DNA from skin lesion swabs, particularly pustular or vesicular rash samples.
The test is intended for use by trained clinical laboratory personnel proficient in PCR techniques and in vitro diagnostic procedures.
This new assay will allow healthcare professionals to confirm mpox cases efficiently and with high accuracy, thereby improving response efforts.
Dr. Yukiko Nakatani, WHO’s Assistant Director-General for Access to Medicines and Health Products, highlighted the significance of this development, noting that the listing of the first mpox diagnostic test under the EUL procedure marks a major milestone in enhancing testing capacity in affected regions.
Dr. Nakatani emphasized that expanding access to high-quality medical products is central to WHO’s mission of helping countries contain the virus and protect their populations, particularly in underserved areas.
The EUL process is designed to expedite the availability of life-saving medical products, such as vaccines, diagnostic tests, and treatments, in response to a Public Health Emergency of International Concern (PHEIC).
WHO issued a call for manufacturers of mpox IVDs to submit expressions of interest for EUL consideration on August 28, 2024, recognizing the urgent need to strengthen global testing capabilities as the virus continued to spread.
The EUL process evaluates the quality, safety, and performance of essential health products to guide procurement agencies and WHO Member States in making informed decisions for emergency procurement.
To date, WHO has received three additional submissions for EUL evaluation, and discussions are ongoing with other manufacturers of mpox IVDs.
Expanding the range of quality-assured diagnostic options will help countries that have not approved these medical products through their own regulatory processes to obtain critical testing supplies through UN agencies and other procurement partners.
The EUL for the Alinity m MPXV assay will remain valid as long as the PHEIC related to mpox is in effect, ensuring continued access to this important diagnostic tool.
