By Colin Kellaher
Danaher Corp.'s Beckman Coulter unit on Friday said its Access SARS-CoV-2 IgM assay received U.S. Food & Drug Administration emergency-use authorization.
Beckman Coulter said the test, which detects antibodies that recognize the receptor binding domain of the spike protein that the SARS-CoV-2 virus uses to enter the human host cells, demonstrates 99.9% specificity and 98.3% sensitivity.
Beckman Coulter said the test is part of a suite of diagnostic solutions it is developing in response to the coronavirus pandemic.
The company previously received FDA emergency-use authorization for its Access SARS-CoV-2 IgG assay and its interleukin 6 assay, which can be used to assist in identifying severe inflammatory response in patients with confirmed Covid-19 illness.
Write to Colin Kellaher at firstname.lastname@example.org
(END) Dow Jones Newswires