FDA Grants Emergency Use Authorization for Nano-Ditech's Flu/COVID Point-of-Care Test

Original from: 360dx

The US Food and Drug Administration recently granted Emergency Use Authorization for a combination COVID-19 and influenza point-of-care test developed by Nano-Ditech.

The Nano-Check Influenza+COVID-19 Dual Test is designed for the qualitative detection and differentiation of antigens from influenza A and B, as well as SARS-CoV-2 in anterior nasal swab specimens collected from symptomatic individuals. The lateral flow immunochromatographic assay is authorized for use within the first five days of symptom onset when tested at least twice over three days with at least 48 hours between tests.

Use of the test is limited to labs CLIA-certified to perform moderate, high, or waived complexity tests and in patient care settings operating under a CLIA Certificate of Waiver, Certificate of Compliance, or Certificate of Accreditation, according to the FDA.

About a year ago, Cranbury, New Jersey-based Nano-Ditech — a subsidiary of South Korea's Precision Biosensor — received EUA from the FDA for an over-the-counter COVID-19 antigen test.

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Source: FDA Grants Emergency Use Authorization for Nano-Ditech's Flu/COVID Point-of-Care Test