Influenza A/B Antigen Rapid Test
Colloidal gold lateral flow antigen test for rapid detection of Influenza A and B viruses from nasopharyngeal or nasal swab specimens.
Cassette
15 minutes
10,000 tests
24 months
Product Specifications
| Format | Cassette |
| Sample Type | Nasopharyngeal Swab, Nasal Swab |
| Accuracy | >95% sensitivity, >98% specificity |
| Reading Time | 15 minutes |
| Storage | 2-30°C |
| Shelf Life | 24 months |
| Methodology | Lateral Flow Immunoassay (Colloidal Gold) |
Testing Methodology
This product uses lateral flow immunoassay (LFIA) technology with colloidal gold conjugates. The immunochromatographic test strip provides rapid qualitative detection through antigen-antibody reactions. When the sample is applied, it migrates along the membrane by capillary action, interacting with pre-coated reagents to produce visible colored lines indicating the result. No laboratory equipment is required.
Product Details
Product Overview
The Golden Time Influenza A/B Antigen Rapid Test is a qualitative immunochromatographic assay for the rapid detection and differentiation of Influenza Type A and Type B viral nucleoprotein antigens directly from nasopharyngeal or nasal swab specimens. Using colloidal gold lateral flow technology, this point-of-care test delivers reliable results in 15 minutes without laboratory equipment.
Intended Use
This rapid antigen test is designed for:
- Point-of-care testing in pharmacies and urgent care centers
- Private clinic and hospital emergency departments
- School and workplace health screening
- Travel checkpoints and border health screening
- Seasonal flu surveillance programs
Key Features
- Dual detection — Simultaneously detects and differentiates Influenza A and B
- Fast turnaround — Visual results in 15 minutes
- Simple procedure — One-step test with minimal training required
- POCT suitable — No instrumentation needed
- Stable storage — Room temperature storage (2-30°C)
- Self-test format available — Consumer-friendly version for home use
Specifications
The test kit includes individually pouched cassettes with built-in control lines, sterile swabs, extraction buffer tubes, and multilingual instructions. The cassette displays three result areas: Control (C), Influenza A (A), and Influenza B (B).
Clinical Performance
Clinical validation studies demonstrate >95% sensitivity and >98% specificity when compared to RT-PCR reference methods. Performance is optimized for samples collected within the first 5 days of symptom onset when viral load is highest.
Target Users
This influenza rapid test serves healthcare professionals in pharmacies, clinics, hospitals, and public health programs. A professional-use version and a self-test (home use) version are available to meet different market requirements.
OEM/ODM Customization
Partner with us for custom respiratory test solutions:
- Private label branding for pharmacy chains
- Custom packaging designs for retail or professional markets
- Combo test configurations (Flu A/B + COVID-19)
- Multi-language instruction inserts
- Self-test format for consumer distribution
- Regulatory dossier support for CE marking and local registrations
Regulatory Status
CE marked under IVD Regulation (EU) 2017/746. Manufactured in ISO 13485 certified facility with GMP compliance. Documentation available for regulatory submissions in European Union, Southeast Asia, and Middle East markets.
Contact our team for wholesale pricing and OEM partnership opportunities.
Certifications & Compliance
Target Markets
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