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RAPID Influenza A/B
Registration Certificate: No. RZN 2023/21057
A lateral flow immunoassay for qualitative detection of Influenza A/B virus antigens in oropharyngeal/nasopharyngeal swab specimens
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The Current Diagnostic Landscape
Epidemiological Landscape
Influenza remains a critical seasonal threat driven by the annual circulation of evolving Influenza A and B strains. In the 2025−2026 season, Influenza A (H3N2) — historically associated with higher clinical severity — maintains significant epidemiological dominance. Simultaneously, Influenza B strains continue to contribute to the overall disease burden, posing a particular risk of severe respiratory complications in pediatric and high-risk groups.
Influenza remains a critical seasonal threat driven by the annual circulation of evolving Influenza A and B strains. In the 2025−2026 season, Influenza A (H3N2) — historically associated with higher clinical severity — maintains significant epidemiological dominance. Simultaneously, Influenza B strains continue to contribute to the overall disease burden, posing a particular risk of severe respiratory complications in pediatric and high-risk groups.
Diagnostic Necessity
The continuous antigenic drift of influenza viruses, combined with the co-circulation of SARS-CoV-2 and other respiratory pathogens, makes symptom-based clinical diagnosis unreliable. This complexity necessitates precise laboratory confirmation to ensure appropriate patient management. The Rapid Bio Influenza Test is specifically engineered to detect current antigenic variants, providing high sensitivity for both Influenza B and the predominant A (H3N2) "Hong Kong" strain.
The continuous antigenic drift of influenza viruses, combined with the co-circulation of SARS-CoV-2 and other respiratory pathogens, makes symptom-based clinical diagnosis unreliable. This complexity necessitates precise laboratory confirmation to ensure appropriate patient management. The Rapid Bio Influenza Test is specifically engineered to detect current antigenic variants, providing high sensitivity for both Influenza B and the predominant A (H3N2) "Hong Kong" strain.
Clinical Impact & Benefits
01
Optimized Early-Stage Treatment
Rapid confirmation of Influenza A/B allows for antiviral therapy initiation within the critical 24−48 hour window, maximizing efficacy and significantly reducing the risk of severe complications.
02
Precision Differential Diagnosis
Clinical symptoms often overlap with other respiratory infections. Laboratory testing prevents diagnostic errors, reduces unnecessary antibiotic over-prescription, and avoids avoidable hospitalizations.
03
Outbreak Prevention and Control
Immediate detection in workplaces and healthcare facilities enables rapid infection control and isolation. This effectively breaks the chain of transmission and prevents large-scale outbreaks in communal settings.
Key Advantages
Optimized for patients with respiratory symptoms and for post-exposure monitoring of close contacts.
Distinguishes Influenza from COVID-19 and other pathogens, preventing diagnostic errors and unnecessary antibiotic overuse.
Provides critical data for epidemiological monitoring, enabling healthcare facilities to effectively plan seasonal resources.
Technical Specifications
Time to Result:
5−12 minutes
Analytical Sensitivity (LOD):
0.3 ng/mL
Reproducibility:
100%
Self Life:
20 minutes
Interpretation
Negative Result
Only the control line "C" appears in the test window. No color appears on the test line "A" or "B".
Positive Result
Two colored lines appear in the test window: the control line "C" and the test line "A" or "B".
The color intensity of the test line may vary.
The color intensity of the test line may vary.
Invalid Result
The control line “C” does not appear in the test window, regardless of whether the test line “A” and/or “B” is present.
An invalid result may be caused by incorrect performance of the test procedure or by the unsuitability of the medical device. In this case, it is recommended to repeat the testing procedure.
An invalid result may be caused by incorrect performance of the test procedure or by the unsuitability of the medical device. In this case, it is recommended to repeat the testing procedure.
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