Abbott Molecular Receives EUA for Monkeypox Test
Abbott Molecular has received Emergency Use Authorization (EUA) from the FDA for its Alinity m MPXV laboratory-based monkeypox test.
The EUA approves the real-time polymerase chain reaction test for qualitative detection of DNA from monkeypox virus in human lesion swab specimens — swabs of acute pustular or vesicular rash.
The Alinity m MPXV assay is designed to be used with the company’s Alinity m system or other authorized instruments. Testing is limited to laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 that meet the requirements to perform moderate or high complexity tests.