The World Health Organization (WHO) has made a significant advancement in global health by listing the Alinity m MPXV assay, manufactured by Abbott Molecular Inc., as the first mpox in vitro diagnostic (IVD) test under its Emergency Use Listing (EUL) procedure. This approval is crucial for enhancing access to mpox testing, especially in regions experiencing outbreaks.
With over 30,000 suspected mpox cases reported in Africa in 2024, particularly in the Democratic Republic of the Congo, Burundi, and Nigeria, the need for rapid and accurate testing is critical. Currently, only 37% of suspected cases in the Democratic Republic of the Congo have been tested this year, underscoring the urgent need for improved diagnostic capacity.
The Alinity m MPXV assay utilizes real-time polymerase chain reaction (PCR) to detect monkeypox virus (clade I/II) DNA from skin lesion swabs. It is designed for use by trained laboratory personnel skilled in PCR techniques. By confirming the presence of the virus through nucleic acid amplification testing (NAAT), healthcare providers can facilitate timely diagnosis and treatment, aiding in the control of the virus.
Dr. Yukiko Nakatani, WHO Assistant Director-General for Access to Medicines and Health Products, stated, “This diagnostic test marks a significant milestone in expanding testing availability in affected countries. Increasing access to quality-assured medical products is essential in our efforts to contain the virus and protect vulnerable populations.”
The EUL process enables the expedited availability of essential health products during public health emergencies. Following the WHO’s call for mpox IVD manufacturers to submit expressions of interest on August 28, 2024, the organization has received three additional submissions for EUL evaluation, with ongoing discussions to broaden the range of diagnostic options available.
The emergency use authorization for the Alinity m MPXV assay will remain valid as long as the public health emergency related to mpox is in effect. For more information on active EUL applications for mpox IVDs, please visit the WHO website.
Source:
The World Health Organization
