CorDx® Tyfast Flu A/B & COVID-19

CorDx® Tyfast Flu A/B & COVID-19 - 25 Test Kit (CLIA Waived)

REF: ACT21001-25

The CorDx Tyfast Flu A/B & COVID-19 Multiplex Rapid Test is a lateral flow immunochromatographic assay intended for in vitro rapid, simultaneous qualitative detection and differentiation of influenza A and influenza B nucleoprotein antigens and SARS-CoV-2 nucleocapsid antigen directly from anterior nasal swab specimens of individuals with signs and symptoms of respiratory 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 test 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. 

Product Highlights:
 

• Authorized by the FDA via EUA
• CLIA Waived Test
• Clinical Performance:
  • COVID-19: 89.6% Sensitivity (PPA)and 99.8% Specificity (NPA)
  • Flu A: 85% Sensitivity (PPA) and 99.2% Specificity (NPA)
  • Flu B: 87.5% Sensitivity (PPA) and 99.8% Specificity (NPA)
• Results in 10 Minutes
• 19 Months Expiration Date
• Positive and Negative Controls Included (Separate Box)