December 2022—The FDA issued emergency use authorization to Abbott Molecular for the Alinity m MPXV, a real-time polymerase chain reaction test intended to detect monkeypox DNA using lesion swab specimens from individuals suspected of monkeypox virus infection. The test is intended for use by qualified clinical laboratory personnel specifically instructed and trained in the techniques of PCR and in vitro diagnostic procedures. Testing is limited to CLIA-certified laboratories that meet the requirements to perform moderate- or high-complexity tests.
The Alinity m MPXV test is the first commercial test kit to be authorized for detection of monkeypox.
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