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Sekisui Diagnostics Gets FDA Emergency Use Authorizations for Point-of-Care COVID, Flu Combo Tests

NEW YORK — The US Food and Drug Administration last week granted Emergency Use Authorizations for two point-of-care COVID-19 and influenza combination tests developed by Sekisui Diagnostics.

The Osom Flu SARS-CoV-2 Combo Test is designed for the simultaneous qualitative detection and differentiation of influenza A and B nucleoprotein antigens, as well as SARS-CoV-2 nucleocapsid antigen, directly from anterior nasal swab specimens. The lateral flow immunochromatographic assay is authorized for use by healthcare providers when testing individuals within four days of symptom onset when tested at least twice over three days with at least 48 hours between tests.

It may be used by labs CLIA-certified to perform moderate-, high-, or waived-complexity tests and at the point of care, according to the FDA.

The over-the-counter Osom Flu SARS-CoV-2 Combo Home Test also detects and differentiates between influenza A, influenza B, and SARS-CoV-2 protein antigens but is authorized for at-home use with anterior nasal swab specimens self-collected within the first four days of symptom onset when tested at least twice over three days with at least 48 hours between tests.

Earlier this year, Burlington, Massachusetts-based Sekisui Diagnostics — a subsidiary of Japan's Sekisui Chemical — inked an exclusive US distribution deal for Aptitude Medical Systems' point-of-care Aptitude Metrix COVID-19 Test.