Healgen Scientific GCFC-525SA COVID-19 / Flu A&B Ag Combo Ra
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COVID-19 / Flu A&B Ag Combo Rapid Test Cassette (Swab)

SKU: MD836525
MFG Part#: GCFC-525SA
In Stock
Sale:

$199.00

25 / Kit
was $215.00
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What's In The Box:
  • 25 Test Cassettes (individually sealed)
  • 25 Sterile Nasal Swabs
  • 25 Pre-filled Extraction Tubes
  • 25 Extraction Tube Tips
  • 2 Tube Holders
  • 1 Instruction Sheet for Healthcare Providers
  • 1 Fact Sheet for Healthcare Providers
  • 1 Fact Sheet for Patients
  • 1 Quick Reference Guide (QRG)
Manufacturer’s Downloads
Description
The Healgen® COVID-19/Flu A&B Ag Combo Rapid Test Cassette is a lateral flow immunochromatographic assay designed for the rapid detection and differentiation of SARS-CoV-2, influenza A, and influenza B antigens. This point-of-care diagnostic tool is specifically intended for use within the first five days of symptom onset in individuals with respiratory infection symptoms. This test is CLIA-waived, offering healthcare providers a fast, reliable means of diagnosing viral infections with a single nasal swab sample. Results are available in just 15 minutes, aiding in timely patient care and reducing the spread of infection.
Features
  • Triple Detection Capability: Identifies SARS-CoV-2, Influenza A, and Influenza B from a single nasal swab.
  • Fast Results: Provides results in as little as 15 minutes, allowing for immediate clinical decisions.
  • CLIA Waived: Suitable for point-of-care testing by minimally trained healthcare professionals.
  • High Accuracy: Shows excellent test performance, comparable to RT-PCR, with positive percent agreements of 90.2% (COVID-19), 90.0% (Flu A), and 91.2% (Flu B).
  • Long Shelf Life: Stable for up to 16 months at room temperature (2-30°C/36-86°F), covering multiple viral seasons.
  • External Quality Controls Available: Enables consistent quality checks to ensure reliable results.
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Product Specifications
Test Type: Immunochromatographic assay (lateral flow)
Time to Result: 15 minutes
Storage Conditions: Room temperature (2-30°C/36-86°F)
Shelf Life: 16 months from manufacture
Sample Type: Anterior nasal swab
Regulatory Status: Emergency Use Authorization (EUA) by FDA, not FDA cleared or approved
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