Streamlining Mpox Diagnostics: WHO’s Expanded Emergency Use Listing
In response to global public health emergencies, the World Health Organization (WHO) has!!! been consistently working to enhance testing options. Recently, the WHO’s Emergency Use Listing (EUL) procedure has expanded to include two new mpox in vitro diagnostics. These additions aim to bolster the quality-assured testing capabilities, particularly in low- and middle-income countries (LMICs).
Polymerase Chain Reaction (PCR) Tests as the Gold Standard
Polymerase Chain Reaction (PCR) remains the gold standard for diagnosing mpox infections. It detects viral DNA with great accuracy, ensuring timely and efficient testing.
WHO-Listed Tests for Enhanced Access
The Xpert Mpox: Rapid Testing at the Point of Care
- Listing Date: 25 October
- Manufacturer: Cepheid
- System Compatibility: GeneXpert
- Processing Time: Under 40 minutes
- Features: Easy to operate, fully automated, real-time PCR detection of mpox clade II, supports decentralized testing
The cobas MPXV Assay: High-Volume Testing for Large Laboratories
- Listing Date: 14 October 2024
- Manufacturer: Roche Molecular Systems, Inc.
- System Compatibility: cobas 6800/8800 Systems
- Detection Time: Under 2 hours
- Features: Detects both mpox clades, suitable for clinical labs handling large volumes
The Crucial Role of WHO in Tackling Mpox Outbreaks
The rapid availability of quality-assured mpox diagnostics is a cornerstone in the control of virus outbreaks. According to Dr. Rogerio Gaspar, WHO Director for Regulation and Prequalification,
“Ensuring global access to mpox diagnostic tests that meet WHO standards for quality, safety and performance is essential for efficient and effective testing in settings affected by mpox outbreaks. Rapid access to those listed products is critical not only for prompt diagnosis and timely treatment but also for effectively containing the spread of the virus."
Addressing the Testing Gap in LMICs
As of 2024, over 40,000 suspected mpox cases have been reported in 18 countries, with many remaining unconfirmed due to limited testing capacity, especially in LMICs. The Democratic Republic of Congo is one country facing significant challenges, but testing has started to improve following WHO’s support for decentralization.
Collaborative Efforts for International Access
- … Efforts: WHO is working with manufacturers and national regulatory authorities in affected countries to facilitate domestic registration or emergency listings.
- … Excluding Priority Targets: Processing new applications for quality-assured mpox tests, ensuring manufacturers fulfill prequalification requirements for international procurement.
Keeping Up with EUL Developments
It’s important to stay informed about the status of mpox diagnostics under the WHO’s EUL procedure. The current status and application developments can be viewed on WHO’s official web pages.
Call to Action
For manufacturers of mpox in vitro diagnostic tests, if you have not yet done so, it is essential to submit expressions of interest for WHO’s Emergency Use Listing. This can be a pivotal step in expanding global testing capabilities and combating mpox outbreaks on a larger scale.
