Abbott nabs first FDA EUA for a commercial test kit to detect monkeypox

Infectious Diseases Research Social

The U.S. Food and Drug Administration (FDA) said on Friday that it has issued an Emergency Use Authorization (EUA) to Abbott Molecular for a real-time polymerase chain reaction (RT-PCR) test intended to detect monkeypox DNA using lesion swab specimens from individuals suspected of monkeypox virus infection.

The test, called the Alinity m MPXV, is the first commercial test kit to be authorized for detection of monkeypox.

The Alinity m MPXV test is intended for use by qualified and trained clinical laboratory personnel specifically instructed and trained in the techniques of RT-PCR and in vitro diagnostic procedures; furthermore, testing is limited to laboratories certified under CLIA, FDA said.

Results are for the identification of monkeypox virus (clades I/II) DNA which is generally detectable in human pustular or vesicular lesion specimens during the acute phase of infection.

In September,  the agency issued the first EUA for a monkeypox in vitro diagnostic test to a diagnostics laboratory for the Quest Diagnostics Monkeypox Virus Qualitative RT-PCR test.   

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