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FDA Grants Emergency Use Authorization for Nano-Ditech Point-of-Care SARS-CoV-2 Antigen Test

NEW YORK — The US Food and Drug Administration this week granted Emergency Use Authorization for Nano-Ditech's point-of-care Nano-Check COVID-19 Antigen Test.

The lateral flow immunoassay is designed for the qualitative detection of SARS-CoV-2 nucleocapsid protein antigen in direct nasopharyngeal swab specimens collected from individuals suspected of having COVID-19 within the first five days of symptom onset. It is also authorized for use in asymptomatic individuals when testing is performed twice over two or three days with at least 24 hours and no more than 48 hours between tests.

The test may only be used by labs CLIA-certified to perform moderate-, high-, or waived-complexity tests, as well as in point-of-care settings operating under a CLIA Certificate of Waiver, Certificate of Compliance, or Certificate of Accreditation.

Cranbury, New Jersey-based Nano-Ditech is a subsidiary of South Korea's Precision Biosensor.