Status™ COVID-19/Flu A&B antigen testStatus™ COVID-19/Flu A&B antigen test

Status™ COVID-19/Flu A&B antigen test

A rapid, Point of Care immunochromatographic assay for the simultaneous qualitative detection and differentiation of nucleocapsid antigen from SARS-CoV-2, influenza A and influenza B directly from nasopharyngeal swab specimens obtained from individuals, who are suspected of respiratory viral infection consistent with COVID-19 by their healthcare provider, within the first five days of onset of symptoms.

Status™ COVID-19/Flu A&B antigen test

√  Point-of-Care Rapid Test For 3 Viral Antigens from Just 1 Swab Sample

√  Detects and Differentiates Between SARS-CoV-2, Influenza A, and Influenza B Nucleocapsid Protein Antigen

√  Broad Detection of Influenza A and Influenza B Strains, Including H1N1

√  Influenza Performance Meets 2017 FDA Reclassification Criteria

√  Results in about 15 Minutes - Quick and Reliable

√  Streamlined Procedure with Onboard Extraction - No Sample Transfer Required

√  Pre-Measured, Unit Dose Reagent Capsule - No Counting Drops

√  Easy-to-Read Visual Color Band Signal - No Reader Required

√  Built-in Procedural Control

√  Room Temperature Storage of Test Kit

√  Sensitivity and Specificity

     − COVID-19 - Sensitivity 93.9%, Specificity 100%

     − Flu A - Sensitivity 91.4%, Specificity 95.7%

     − Flu B - Sensitivity 87.6%, Specificity 95.9%

Status™ COVID-19/Flu A&B antigen test

√  Clinical laboratories

√  Independent laboratories