The Cepheid Xpert Mpox test is a real-time polymerase chain reaction (RT-PCR) test intended to detect Mpox virus DNA in lesion swab specimens (i.e., swabs of acute pustular or vesicular rash) from individuals suspected of mpox by their healthcare provider.
The Xpert Mpox is authorized for use on the GeneXpert Dx, GeneXpert Infinity, and GeneXpert Xpress (Hub Configuration) instruments in laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA). Testing on the GeneXpert Xpress (Hub Configuration) instrument is authorized for use at the point of care (POC).
Validation data was gathered through the National Institutes of Health (NIH) Independent Test Assessment Program established as a collaboration between the FDA and the NIH. This EUA is the latest example of the FDA’s ongoing commitment to advance greater consumer access to tests for infectious diseases, the association says.
The EUA is supported by the Secretary of Health and Human Service’s (HHS’s) declaration that circumstances exist to justify the emergency use of in vitro diagnostics (IVDs) for the detection and/or diagnosis of the virus that causes mpox, including in vitro diagnostics that detect and/or diagnose infection with non-variola Orthopoxvirus.