CorDx Covid & Flu Antigen Test

Specifications

• CLIA Waived

• Test type: Rapid Antigen

• Run time: 10 minutes

• Collection type: Lower nasal swab

• SARS-CoV-2: 89.1% PPA, 99.8% NPA

• Flu A: 83.6% PPA, 98.8% NPA

• Flu B: 90.0% PPA, 99.9% NPA

• CPT Codes: Covid-19 87811QW

• Manufacturer: CorDx, Inc.

Storage & Expiration

• Store at 2-30°C (35-86°F)

• Do not freeze any contents of the kit.

• Reagents and materials are stable until expiration date printed on outer packaging.

• Test device must remain in the sealed pouch until use.

Box Components

• Nasopharyngeal swabs (25)

• Test cassettes (25)

• Extraction reagent capsules (25)

• Workstation for mass testing (1)

• Instructions for use (1)

Manuals & Documents

• Instructions for Use

• Quick Reference Guide

• Provider Fact Sheet

• Patient Fact Sheet

Intended Use

The CorDx Tyfast Flu A/B & COVID-19 Multiplex Rapid Test is a lateral flow immunoassay intended for the in vitro rapid, simultaneous qualitative detection and differentiation of nucleocapsid antigen from SARS-CoV2, 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 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.