SEKISUI Diagnostics has introduced a new lateral flow immunoassay device, the OSOM Covid-19 Antigen Home Test.
The new assay has been developed to qualitatively identify nucleocapsid protein antigens from the SARS-CoV-2 virus.
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SEKISUI Diagnostics client services, clinical research and marketing vice-president Erica Blight said: “We are excited to be able to provide consumers with more tools to help diagnose Covid-19 in a fast, easy-to-use format that can be purchased over the counter.
“This supports our goal of bringing diagnostics to where they are needed most, which in this case is at home, so people do not have to travel to medical facilities and can treat or quarantine quickly.”
The test has not received approval from the US Food and Drug Administration but is authorised under a conditional Emergency Use Authorisation.
The product’s authorisation pertains exclusively to the detection of proteins from SARS-CoV-2 and does not extend to any other viruses or pathogens.
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By GlobalDataSEKISUI Diagnostics president and CEO Bob Schruender said: “Our entrance into the home testing market is another way we are providing solutions to enhance life with science to improve the health of all people.
“We understand home testing is a valuable tool and becoming more accepted and necessary, especially when we are experiencing significant waves of respiratory infections as we have seen in previous seasons.”
SEKISUI provides point-of-care tests, pre-analytic systems, clinical chemistry reagents, enzymes and speciality biochemicals to hospitals, laboratories, alternate testing locations and physicians.
