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Abbott Gets FDA Emergency Use Authorization for Monkeypox PCR Test

NEW YORK — The US Food and Drug Administration said Friday it has granted Emergency Use Authorization for Abbott's real-time PCR monkeypox test, the Alinity m MPXV assay.

The test is for use by CLIA-certified laboratories for the detection of monkeypox virus DNA from lesion swab samples. In its authorization letter, the FDA noted that monkeypox virus DNA is generally detectable in human pustular or vesicular lesion specimens during the acute phase of infection.

The assay can be used on Abbott's Alinity m instrument or other authorized instruments, which perform sample preparation, PCR assembly, amplification, detection, and result calculation and reporting, the FDA said, adding it requires use of the Alinity m MPXV CTRL Kit.

The US Department of Health and Human Services declared a state of emergency on Aug. 9 in response to outbreaks with the virus within the United States. Quest Diagnostics received the first EUA for its Monkeypox Virus Qualitative Real-Time PCR test, which detects monkeypox and other non-variola orthopoxvirus DNA in lesion swab specimens.