October 07, 2022
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FDA authorizes Abbott’s monkeypox PCR test for emergency use
The FDA has issued an emergency use authorization to Abbott Molecular for its real-time PCR test for monkeypox using lesion swab specimens from those with suspected virus infection.
The PCR test (Alinity m MPXV) is the first commercial test to be authorized for detection of monkeypox and is limited to laboratories certified under the Clinical Laboratory Improvement Amendments of 1988, according to an FDA press release.
The emergency use authorization is based on the August 2022 determination by the Secretary of the Department of Health and Human Services that there is significant potential for a public health emergency from the monkeypox virus.
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