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Products: COVID-19 Test

Status™ COVID-19/Flu A&B - Rapid SARS-CoV-2/Influenza A+B Antigen Panel 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 anterior nasal or 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.

FDA Emergency Use Authorization for Use in CLIA Waived Settings

Influenza Annual Reactivity Testing Data (2019-2020-2021) [PDF, 135 KB]

Highlights

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
Superior performance for COVID-19: Sensitivity 93.9%, Specificity 100%
Same superior performance for influenza A+B as BioSign® Flu A+B and Status™ Flu A&B
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

Key to Simple Results

Control line (C): a colored Control line indicates the test is working properly.
Test line (T): a colored Test line (A, B or CoV19) indicates the test is POSITIVE for that viral antigen (i.e., influenza A, B or COVID-19 positive).
Sample well (S): Insert swab and perform onboard extraction.

Important EUA Documents

Instructions for Use [PDF]

Quick Reference Instructions [PDF]

Fact Sheet for Patients [PDF]

Fact Sheet for Healthcare Providers [PDF]