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OnSite™ Influenza A/B Ag Rapid Test Kit, CE, 20 Tests
Catalog No :
CAS Number :
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Specifications:
| Application | Diagnostic Testing | ||
| Storage Temperature | Room Temperature | ||
| Product Type | Test Kit | Forms | Kit with Various components |
| Product Brand | CTK Biotech | ||
| Product Grade | Medical grade | ||
The OnSite® Influenza A/B Ag Rapid Test is a lateral flow immunoassay for the qualitative detection and differentiation of Influenza A virus (including H5N1 and H1N1) and Influenza B virus in nasal, nasopharyngeal, or throat swab specimens. Designed for use by minimally trained personnel, this CE-marked test provides results in just 15 minutes, enabling rapid diagnosis and timely treatment decisions without the need for laboratory equipment.
Validated against CDC-recommended influenza strains (2019–2022) including H1N1, H3N2, and both B lineages (Victoria and Yamagata), this assay delivers high sensitivity and specificity, making it an essential tool for influenza diagnostics and outbreak management.
Key Features
- One test, dual detection: Influenza A and Influenza B from a single sample.
- External control swabs included to ensure laboratory quality control.
- Pre-filled extraction tubes simplify workflow and reduce error.
- Simple sample collection using nasal, nasopharyngeal, or throat swabs.
- Rapid results in 15 minutes, no specialized equipment required.
- High accuracy: Validated against multiple influenza strains.
- Shelf life: 24 months at 2–30°C.
Clinical Performance
| Virus | Sensitivity / PPA | Specificity / NPA |
|---|---|---|
| Influenza A | 99.34% (95% CI: 96.34–99.88%) | 100% (95% CI: 99.30–99.98%) |
| Influenza B | 100% (95% CI: 95.47–100%) | 100% (95% CI: 99.53–100%) |
Kit Contents
Each kit (20 tests) contains:
- Individually sealed foil pouches, each with 1 test cassette and 1 desiccant.
- Pre-filled extraction tubes (sealed pouch).
- Extraction tube nozzles.
- Sample extraction tube rack.
- Sterile swabs, individually sealed.
- Positive control swabs: Influenza A Ag and Influenza B Ag, each sealed with desiccant.
- Negative control swab, sealed with desiccant.
- Instructions for Use (IFU).
Specifications
| Parameter | Details |
|---|---|
| Product Name | OnSite Influenza A/B Ag Rapid Test |
| Catalog Number | R0187C |
| Format | 20 tests/kit |
| Specimen Type | Nasal, Nasopharyngeal, Throat swabs |
| Detection | Influenza A virus (incl. H5N1, H1N1, H3N2) and Influenza B virus (Victoria, Yamagata) |
| Principle | Lateral Flow Chromatographic Immunoassay |
| Turnaround Time | 15 minutes |
| Clinical Sensitivity | Flu A: 99.34% PPA |
| Clinical Specificity | Flu A: 100% NPA |
| Storage | 2–30°C, 24-month shelf life |
| Regulatory Status | CE-marked |
Applications
- Rapid diagnosis of Influenza A and B infections.
- Point-of-care testing in hospitals, clinics, and emergency care.
- Outbreak management during influenza seasons.
- Differentiation of influenza subtypes for accurate treatment decisions.
- Public health surveillance in community and epidemic settings.
The OnSite Influenza A/B Ag Rapid Test is a fast, reliable, and user-friendly diagnostic solution for influenza detection and differentiation. With high clinical performance validated against recent CDC strains, convenient kit components, and CE-mark approval, this test is a trusted choice for clinicians, laboratories, and public health authorities. Its ease of use, rapid results, and strong accuracy make it an indispensable tool for influenza diagnosis and outbreak control in both clinical and field settings.