Alinity m MPXV Assay Set to Enhance Global Testing Capacity Amid Mpox Outbreaks
The World Health Organization (WHO) has officially listed the first mpox in vitro diagnostic test under its Emergency Use Listing (EUL) procedure, marking a significant advancement in global access to mpox testing. The Alinity m MPXV assay, manufactured by Abbott Molecular Inc., has been approved for emergency use, which is crucial for expanding diagnostic capabilities in countries currently experiencing mpox outbreaks.
In a statement released on Thursday, WHO emphasized that rapid and accurate testing is vital for effective treatment and control of the mpox virus. The organization noted the persistent issues of limited testing capacity and delays in confirming mpox cases, particularly in Africa, where the virus continues to spread. This year alone, over 30,000 suspected cases have been reported across the continent, with the Democratic Republic of the Congo, Burundi, and Nigeria reporting the highest numbers. Alarmingly, only 37% of suspected cases in the Democratic Republic of the Congo have been tested this year.
The WHO highlighted that the presence of the monkeypox virus is confirmed through Nucleic Acid Amplification Testing, such as real-time or conventional Polymerase Chain Reaction (PCR). The Alinity m MPXV assay is a real-time PCR test specifically designed for detecting monkeypox virus DNA from human skin lesion swabs. It is intended for use by trained clinical laboratory personnel proficient in PCR techniques and in vitro diagnostic (IVD) procedures.
Dr. Yukiko Nakatani, WHO Assistant Director-General for Access to Medicines and Health Products, remarked on the importance of this milestone, stating, “Increasing access to quality-assured medical products is central to our efforts in assisting countries to contain the spread of the virus and protect their people, especially in underserved regions.”
The EUL process expedites the availability of life-saving medical products, including vaccines, tests, and treatments, amid a Public Health Emergency of International Concern (PHEIC). Following a call from WHO on August 28, 2024, for mpox IVD manufacturers to submit expressions of interest for EUL, discussions are ongoing with additional manufacturers to enhance the range of quality-assured diagnostic options.
The emergency use authorization for the Alinity m MPXV assay will remain valid as long as the PHEIC justifying the emergency use of mpox diagnostics is in effect, allowing affected countries to procure critically needed tests through UN agencies and other procurement partners.