WHO lists additional mpox diagnostic tests for emergency use
October 30, 2024
WHO has listed two additional mpox diagnostics under its Emergency Use Listing: Cepheid's Xpert Mpox (October 25) and Roche's cobas MPXV assay (October 14). The Xpert provides results in 40 minutes and detects clade II, while the cobas test identifies both clades in under 2 hours. These PCR-based tests join Abbott's previously approved Alinity m MPXV assay. With over 40,000 suspected mpox cases in 18 countries and limited testing capacity, particularly in low-income countries, these approvals aim to enhance global access to quality-assured testing. WHO is facilitating domestic registration and reviewing additional diagnostic applications.
WHO has significantly expanded testing options for mpox by listing two additional in vitro diagnostics under its Emergency Use Listing (EUL) procedure, addressing critical needs in low- and middle-income countries.
New Approved Diagnostics:
1. Xpert Mpox (Cepheid):
- Listed October 25
- Results in under 40 minutes
- Automated PCR testing
- Detects clade II viral DNA
- Compatible with GeneXpert systems
- Supports decentralized testing
2. cobas MPXV assay (Roche):
- Listed October 14
- Results in under 2 hours
- Detects both mpox clades
- Processes multiple samples simultaneously
- Suitable for high-volume laboratories
- Uses cobas 6800/8800 Systems
Current Context:
- 18 countries reporting over 40,000 suspected cases in 2024
- Most cases remain unconfirmed due to limited testing
- Democratic Republic of Congo showing increased testing but only 40-50% of suspected cases tested
- Previous listing of Abbott's Alinity m MPXV assay on October 3
WHO's Response:
- Working with manufacturers for domestic registration
- Facilitating emergency listings in affected countries
- Received 60+ expressions of interest for EUL review
- Seven progressed to applications
- Two products under review
- Two more applications expected
These approvals represent a significant step in improving global access to quality-assured mpox testing, particularly in resource-limited settings. The variety of approved tests offers options for different testing environments and needs.