Description

ViraDx™ is a point-of-care rapid test to detect and differentiate SARS-CoV-2, Flu A and Flu B from one sample.

A rapid combo test for Sars2, Covid, and Flu A&B providing results within 15 minutes. For professional use only.

Intended Use:

ViraDx SARS-CoV-2/Flu A+B Rapid Antigen 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 influenza B directly from anterior nasal or nasopharyngeal swab specimens collected from individuals, who are suspected of respiratory viral infection consistent with COVID-19 by their healthcare provider.

Key features of product

• EFFICIENT: 3 results to aid in a differential diagnosis from one sample
• RAPID: actionable results in 15 minutes to help improve patient management decisions
• INSTRUMENT-FREE: user-friendly test procedure for non-lab settings

Case components (case of 25 kits)

• 25 ViraDx SARS-CoV-2/Flu A+B Rapid Antigen Test devices. The test strip in each device contains mouse monoclonal antibodies to nucleocapsid protein of influenza A, influenza B and SARS-CoV-2. Each test trip is single-use and device is individually pouched.
• 25 Extraction Reagent Capsules. For use with swab specimens; 300 μL of Phosphate buffer with detergents and preservative.
• 25 Extraction Reagent Tubes. For preparing specimen.
• 25 Sterile Swabs. For swab specimen collection.
• 1 Positive Control Swab. Influenza A, B and SARS-CoV-2 antigen (non-infective recombinant nucleocapsid).
• 1 Negative Control Swab. Inactivated Group B Streptococcus antigen (non-infective).
• 1 Package Insert.
• 1 Quick Reference Instructions.

HIGHLY CORRELATED TO PCR:1
• COVID-19: Sensitivity (Anterior nasal swab) 93.8%; Specificity 100%
• COVID-19: Sensitivity (Nasopharyngeal) 93.1%; Specificity 100%
• Flu A: Sensitivity 92.2%; Specificity 94.2%
• Flu B: Sensitivity 90.0%; Specificity 94.3%

Resources

ViraDX Product Overview

ViraDx-Sell-Sheet-US

ViraDx-Quick reference Instructions

ViraDx US Fast Facts

ViraDx-Fact-Sheet-for-Healthcare-Providers 

FAQs

1. What is the ViraDX Combo Rapid Test? The ViraDX Combo Rapid Test is a diagnostic tool designed to simultaneously detect and differentiate between SARS-CoV-2 (COVID-19) and Influenza A & B viruses from a single specimen.

2. How does the ViraDX Combo Rapid Test work? The test works by detecting specific antigens associated with SARS-CoV-2 and Influenza A & B viruses in nasal swab samples. It provides results quickly, typically within 15-20 minutes.

3. How accurate is the ViraDX Combo Rapid Test? The test demonstrates high accuracy levels comparable to laboratory PCR tests. Sensitivity and specificity may vary, but it is designed to provide reliable results.

4. Who can use the ViraDX Combo Rapid Test? Healthcare professionals and trained personnel can administer the test in clinical settings such as hospitals, clinics, and testing centers.

5. What are the advantages of using the ViraDX Combo Rapid Test?

• Rapid results: Provides results within 15-20 minutes.
• Simultaneous detection: Detects SARS-CoV-2 and Flu A & B viruses from the same sample.
• Ease of use: Simple procedure suitable for healthcare professionals.

6. What are the storage requirements for ViraDx? The ViraDx test should be stored at 2-30°C (35-86°F) in the original sealed pouch, away from direct sunlight.

7. What patient samples can be used on the ViraDx test? The ViraDx test should be used with freshly collected anterior nasal or nasopharyngeal swab specimens. Samples must not be placed in any viral transport media.