Xpert® Mpox Receives Emergency Use Listing by World Health Organization
November 4, 2024
The WHO has granted Emergency Use Listing to Cepheid's Xpert Mpox test, the first point-of-care test to receive FDA Emergency Use Authorization. The test provides results in under 40 minutes, detecting both mpox clades from lesion swabs. This approval is crucial as 18 countries report over 40,000 suspected cases in 2024, with most unconfirmed due to limited testing capacity. The test runs on GeneXpert systems, enabling decentralized testing in near-patient settings, particularly important for low and middle-income countries struggling with the outbreak.
The World Health Organization's Emergency Use Listing of Cepheid's Xpert Mpox test marks a significant advancement in global mpox diagnostics.
Key Features and Implications:
1. Test Characteristics:
- First point-of-care test with FDA EUA
- Results in under 40 minutes
- Detects mpox clade II specifically
- Identifies non-variola Orthopoxviruses
- Uses lesion swab samples
- Based on gold-standard PCR technology
2. Global Impact:
- 18 countries reporting 40,000+ suspected cases
- Most cases remain unconfirmed
- Limited testing capacity in low-income countries
- Significant increase in DRC testing
- Supports decentralized testing efforts
3. Clinical Context:
- Differentiates from similar conditions:
* Chickenpox
* Measles
* Bacterial skin infections
* Syphilis
* Herpes
* Medication allergies
4. Implementation Advantages:
- Uses existing GeneXpert infrastructure
- Enables near-patient testing
- Supports rapid response capabilities
- Facilitates quick deployment
- Provides accurate, actionable results
5. WHO EUL Significance:
- Assesses quality, safety, performance
- Guides procurement decisions
- Supports emergency response
- Enables informed healthcare decisions
This development represents a crucial step in improving global mpox diagnosis and control efforts, particularly in resource-limited settings.