Status™ COVID-19/Flu A&B test is a lateral flow immunoassay intended for the in vitro rapid, simultaneous qualitative detection and differentiation of nucleocapsid protein antigen from SARS-CoV-2, influenza A and/or influenza B directly from nasopharyngeal or anterior nasal swab specimens collected from individuals, who are suspected of respiratory viral infection consistent with COVID-19 by their healthcare provider- within the first five (5) days of symptom onset when tested at least twice over three days with at least 48 hours between tests.
Clinical signs and symptoms of respiratory viral infection due to SARS-CoV-2 and influenza can be similar. Testing is limited to laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, that meet the requirements to perform moderate, high, or waived complexity tests. This product is authorized for use at the Point of Care (POC), i.e., in patient care settings operating under a CLIA Certificate of Waiver, Certificate of Compliance, or Certificate of Accreditation.
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