On Friday, September 2, 2022, the Centers for Disease Control and Prevention (CDC) released a laboratory alert regarding rare false-negative results for the monkeypox virus that were obtained when using assays with the CDC's published primers and probes.
In response to these cases, the CDC recommends the following:
- If your laboratory is using an MPXV-specific laboratory-developed test (LDT), refer highly suspicious monkeypox virus specimens that yield negative results to your public health laboratory or the CDC to confirm results. Public health laboratories and select commercial laboratories use the CDC FDA-cleared NVO test, which can correctly identify orthopoxvirus when the TNF gene deletion occurs.
- Use a multiplex assay that targets multiple viral genes, or an assay that targets an essential viral gene that is unlikely to mutate, or an assay that detects nonvariola orthopoxvirus.
ARUP's Testing for Monkeypox Is Not Affected
ARUP's test, Orthopoxvirus (includes monkeypox virus) by PCR, Orthopoxvirus (includes monkeypox virus) by PCR, complies with these recommendations from the CDC. Our assay detects an essential viral gene and will detect members of the Orthopoxvirus genus, including monkeypox virus and vaccinia virus. Due to the initial assay design and the target selected, ARUP's assay is not affected by the alert sent by the CDC last week.
ARUP is committed to providing excellent patient care and to supporting you during this outbreak.
Please visit our Monkeypox FAQs page for additional details about ARUP's testing, specimen requirements, public health reporting, and more.
View the following resources for more information.
- Monkeypox FAQs
- ARUP Consult: Monkeypox
- Monkeypox: 2022 U.S. monkeypox outbreak. Centers for Disease Control and Prevention. Updated July 28, 2022.
- Preparation and Collection of Specimens. Centers for Disease Control and Prevention. Updated July 29, 2022.
- Lab Alert: MPXV TNF Receptor Gene Deletion May Lead to False Negative Results with Some MPXV Specific LDTs. Centers for Disease Control and Prevention. Updated September 2, 2022.
If you have additional questions, please contact Client Services and use keyword: MONKEYPOX
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