On Oct. 7, 2022, the U.S. Food and Drug Administration (FDA) issued an Emergency Use Authorization (EUA) to Abbott Molecular, for the Alinity m MPXV, a real-time polymerase chain reaction (PCR) test intended to detect mpox DNA using lesion swab specimens from individuals suspected of mpox virus infection. The Alinity m MPXV test is the first commercial test kit to be authorized for detection of mpox.

The Alinity m MPXV assay is a real-time polymerase chain reaction (PCR) test intended for the qualitative detection of DNA from mpox virus in human skin lesion material specimens from individuals suspected of mpox infection by their healthcare provider.

Alinity m is a continuous and random-access molecular analyzer with a time-to-first result of less than 115 minutes enabling you to eliminate batching procedures and improve laboratory workflow. All steps of the Alinity m MPXV (EUA) assay procedure are performed automatically by the Alinity m system with no intermediate processing or transfer steps performed by the user.