



Healgen® COVID-19/Flu A&B Ag Combo Rapid Test
Key Features
Triple Detection: Identifies COVID-19, Influenza A, and Influenza B antigens with one nasal swab.
Rapid Results: Delivers accurate results in as little as 15 minutes.
CLIA Waived: Approved for use in point-of-care settings by trained healthcare professionals.
Reliable Performance: Test results demonstrate strong accuracy with positive percent agreement rates of 90.2% (COVID-19), 90.0% (Flu A), and 91.2% (Flu B).
Extended Shelf Life: Stable up to 16 months at room temperature (2–30°C / 36–86°F), making it convenient for seasonal preparedness.
Quality Controls Available: Optional external quality controls to maintain testing consistency.
Product Specifications
Test Type: Lateral flow immunochromatographic assay.
Time to Results: 15 minutes.
Box Contents (25 Tests)
- 25 Individually Sealed Test Cassettes
- 25 Sterile Nasal Swabs
- 25 Pre-filled Extraction Tubes
- 25 Extraction Tube Tips
- 2 Tube Holders
- Instruction Sheet for Healthcare Providers
- Fact Sheets for Providers & Patients
- Quick Reference Guide (QRG)
This product has not been FDA cleared or approved, but it has been authorized by the FDA under an Emergency Use Authorization (EUA) for use by authorized laboratories. It is only authorized for the detection of SARS-CoV-2, Influenza A, and Influenza B antigens and should not be used for detection of any other pathogens.
