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08/27/2024: Lab Advisory: Recommendations for Mpox Specimen Testing
Audience: Clinical Laboratory Professionals
Level: Laboratory Advisory
On August 7, 2024, the U.S. Centers for Disease Control and Prevention (CDC) issued a Health Alert Network (HAN) Health Update about the ongoing mpox outbreak in the Democratic Republic of the Congo (DRC) and its spread to neighboring countries. The first Health Advisory about this outbreak was released in December 2023.
For all laboratories performing mpox testing using an orthopoxvirus or monkeypox virus (MPXV) generic test without any additional clade-specific testing occurring, CDC recommends that laboratories send clinical specimens collected from patients who traveled from DRC, its neighboring countries, or any country with clade I mpox cases, or had close or intimate contact with symptomatic people from these countries, to a laboratory that can perform clade-specific testing as quickly as possible. If clade-specific testing is warranted but is not available in a jurisdiction, specimen submission to a capable public health laboratory or to CDC is encouraged. Specimen submission to CDC can be coordinated through your state or local health department. Due to mutations that may impact clade-specific PCR tests, laboratories should use a test that targets a viral essential gene (e.g., the CDC NVO test) as part of a testing strategy to ensure mpox cases are not missed.
Laboratories using CDC’s non-variola orthopoxvirus (NVO) test should continue submitting the duplicate specimen to CDC from all patients with positive NVO test results for routine MPXV clade-specific testing if they are not performing clade-specific testing in their laboratory. Specimens that cannot be accepted at CDC for clinical testing under Clinical Laboratory Improvement Amendments (CLIA) will be redirected for surveillance purposes and tested, providing critical data on MPXV clade(s) circulating in the United States. Some non-CDC laboratories may have other options available for clade-specific testing (e.g., molecular testing or genetic sequencing). These laboratories should alert their state health department and CDC (poxvirus@cdc.gov) if results from such tests indicate detection of clade I MPXV.
Please review the HAN for more information, including recommendations for clinicians, health departments, laboratories, and the public.
We encourage you to share this message widely with your network(s).
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Online Resources
- About Mpox | Mpox | Poxvirus | CDC
- Mpox Caused by Human-to-Human Transmission of Monkeypox Virus in the Democratic Republic of the Congo with Spread to Neighboring Countries | HAN
- Mpox Caused by Human-to-Human Transmission of Monkeypox Virus with Geographic Spread in the Democratic Republic of the Congo | HAN
- Test Order | Submitting Specimens to CDC | Infectious Diseases Laboratories | CDC
- After Hours/Epi-on-Call Contact Lists | CSTE
- Mpox Rapid Risk Assessment | CDC
Questions?
- If you are a clinical or public health laboratory professional, contact LOCS.
- For media inquiries, contact the CDC Newsroom.
- For all other questions, contact CDC-INFO.
Thank you,
The Laboratory Outreach Communication System
Laboratory Outreach Communication System (LOCS) | Division of Laboratory Systems (DLS)
Center for Laboratory Systems and Response (CLSR)
Centers for Disease Control and Prevention (CDC)