Healgen Gets Emergency Use Authorization for COVID, Flu Combo Test

Original from: 360dx

The US Food and Drug Administration has granted Emergency Use Authorization to Healgen Scientific for a point-of-care combination antigen test for COVID-19 and influenza A/B.

The Healgen COVID-19/Flu A&B Ag Combo Rapid Test Cassette is a lateral flow assay that is used for the qualitative detection and differentiation of SARS-CoV-2 and flu A/B nucleocapsid protein antigens in anterior nasal swab samples from individuals with signs and symptoms of respiratory infection within the first five days of symptom onset. The test is approved for use when patients are tested at least twice in three days with at least 48 hours between tests.

Negative results are presumptive and may be confirmed with a molecular assay.

Healgen also received FDA 510(k) clearance earlier this year for its Healgen Rapid COVID-19 Antigen Test, which is a prescription-use lateral flow immunoassay for COVID-19.

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Source: Healgen Gets Emergency Use Authorization for COVID, Flu Combo Test