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Sekisui Diagnostics Receives FDA Clearance, CLIA Waiver for Influenza Test

NEW YORK – Sekisui Diagnostics announced today its Acucy Influenza A&B test has received 510(k) clearance from the US Food and Drug Administration, as well as a CLIA waiver for use on the Acucy Reader.

The test consists of a rapid chromatographic immunoassay used to detect influenza A and B viral nucleoprotein antigens from nasal and nasopharyngeal swabs and can be used with the Acucy Reader in either point-of-care or laboratory settings. Sekisui said that combining the test with the Reader gives clinicians standardized and definitive result interpretation whether a patient has influenza.

With the clearance of this test, the Burlington, Massachusetts- based company has a portfolio of three common modalities in the CLIA-waived environment with its OSOM Ultra Flu A&B Test for manual read lateral flow and its molecular point-of-care Silaris Influenza A&B Test.