The Xpert Mpox* test, authorized for use under FDA Emergency Use Authorization (EUA), provides a clade II-specific call out where positive specimens are excluded from select agent program requirements.
The Xpert Mpox* test delivers the convenience of on-demand testing with fast and accurate results. Some of the key benefits include:
- High quality, actionable results in approximately 36 minutes
- Can be performed in point of care (POC) settings as well as in moderate and high complexity laboratories
- Suitable for low to high test volumes due to the flexibility of on-demand testing
- Less than 1 minute of hands-on time, and no specimen prep
The Xpert Mpox* test, performed on Cepheid's GeneXpert®
systems, delivers accurate results, simplifies testing, and provides flexibility to deliver results when and where needed for timely clinical management
*This product has not been FDA cleared or approved, but has been authorized for emergency use by FDA under an EUA for use by the authorized laboratories; This product has been authorized only for the detection of nucleic acid from monkeypox virus or other non-variola orthopoxviruses, not for any other viruses or pathogens; and the emergency use of this product is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection and/or diagnosis of infection with the monkeypox virus, including in vitro diagnostics that detect and/or diagnose infection with non-variola Orthopoxvirus, under Section 564(b)(1) of the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. § 360bbb-3(b)(1), unless the declaration is terminated or authorization is revoked sooner.