The World Health Organization (WHO) has approved the first in vitro diagnostic (IVD) test for monkeypox (mpox) under its Emergency Use Listing (EUL) procedure. This approval aims to enhance global access to mpox testing, particularly in countries facing outbreaks where quick and accurate testing is crucial.
Diagnostic Test Approval
The Alinity m MPXV assay, manufactured by Abbott Molecular Inc., is the first mpox diagnostic test to receive emergency use authorization. It is a real-time PCR test designed to detect monkeypox virus (clade I/II) DNA from human skin lesion swabs.
The Need for Increased Testing Capacity
This approval comes in response to the urgent need for increased diagnostic capacity. Over 30,000 suspected mpox cases have been reported in Africa this year, with the highest numbers in the Democratic Republic of the Congo, Burundi, and Nigeria. Only 37% of suspected cases in the Democratic Republic of the Congo have been tested this year.
Confirmation of Mpox Diagnosis
The presence of the monkeypox virus is confirmed through nucleic acid amplification testing (NAAT), such as real-time or conventional polymerase chain reaction (PCR). The recommended specimen type for diagnostic confirmation is lesion material.
Global Impact of Early Diagnosis
Early diagnosis of mpox enables timely treatment and care, which is essential for controlling the virus. The EUL process accelerates the availability of life-saving medical products during a Public Health Emergency of International Concern (PHEIC).
WHO’s Future Plans for Mpox Testing
WHO is conducting three other assessments (two abridged and one full assessment procedure) of candidates for EUL of MPXV diagnostic products. This will support countries that have not approved these medical products through their own approval processes to procure critically needed tests through UN agencies and other procurement partners.
Statement from WHO
Dr. Yukiko Nakatani, WHO Assistant Director-General for Access to Medicines and Health Products, emphasized that this approval represents a significant milestone in expanding testing availability in affected countries. Increasing access to quality-assured medical products is central to WHO’s efforts in assisting countries to contain the spread of the virus and protect their populations, especially in underserved regions.
Conclusion
The approval of the Alinity m MPXV assay is a crucial step in enhancing global diagnostic capacity for mpox, thereby supporting the control and treatment of the virus.
Frequently Asked Questions (FAQs)
What is mpox?
Mpox is a viral disease that can cause flu-like symptoms and a rash. It is transmitted to humans from animals and can also spread from person to person.
How is the Alinity m MPXV assay used to diagnose mpox?
The Alinity m MPXV assay is a real-time PCR test that detects the genetic material of the monkeypox virus in skin lesion swabs.
Why is increased testing capacity important for controlling mpox outbreaks?
Increased testing capacity helps to identify infected individuals quickly, allowing for timely treatment and isolation to prevent further spread of the virus.
What is WHO’s role in the global response to mpox?
WHO plays a crucial role in coordinating the global response to mpox, including providing guidance, supporting surveillance and testing efforts, and facilitating access to diagnostics and treatments.
Source: World Health Organization