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Updated: Jun 19, 2026
High-throughput Detection Method for Influenza Virus
Published on: February 4, 2012
[Comparison of detection sensitivity in rapid-diagnosis influenza virus kits]
Osamu Tokuno1, Miki Fujiwara, Yoshimi Nakajoh
1Clinical Laboratory, Kobe University Hospital.
Insights
Sensitivity of rapid influenza diagnostic kits varies. This study compared eight kits, finding significant differences in detecting influenza A and B viruses, with influenza A generally detected more sensitively.
Area of Science:
- Clinical Virology
- Diagnostic Technology
- Immunology
Background:
- Rapid-diagnosis kits for influenza A and B viruses are crucial for early detection.
- Existing immunochromatography-based kits show wide variations in sensitivity.
- Standardized evaluation of these kits is necessary to ensure reliable diagnostic performance.
Purpose of the Study:
- To compare the detection sensitivity of eight commercially available rapid influenza diagnostic kits.
- To evaluate kit performance against standardized influenza virus stocks, including vaccine and clinical strains.
- To identify potential factors influencing the variability in diagnostic sensitivity.
Main Methods:
- Eight different rapid influenza diagnostic kits were tested.
- Sensitivity was assessed using serial dilutions of influenza A (H1N1, H3N2) and B virus stocks.
- Minimum detection concentrations were determined and correlated with RNA copy numbers quantified by real-time reverse transcriptase-polymerase chain reaction (RT-PCR).
Main Results:
- Significant differences in detection sensitivity were observed among the tested kits.
- Sensitivity varied across different influenza virus subtypes (A/H1N1, A/H3N2, B).
- Generally, influenza A viruses demonstrated higher detection sensitivity compared to influenza B viruses across the evaluated kits.
Conclusions:
- The sensitivity of rapid influenza diagnostic kits is not uniform and varies significantly between manufacturers and virus types.
- Factors such as monoclonal antibody specificity, specimen processing, and assay design may contribute to observed sensitivity differences.
- Clinical laboratories should be aware of these performance variations when selecting and utilizing rapid influenza diagnostic tests.
Abstract:
Rapid-diagnosis kits able to detect influenza A and B virus by immunochromatography developed by different manufacturers, while useful in early diagnosis, may vary widely in detection sensitivity. We compared sensitivity results for eight virus-detection kits in current use--Quick Chaser FluA, B (Mizuho Medy), Espline Influenza A & B-N (Fujirebio), Capilia Flu A + B (Nippon Beckton Dickinson & Alfesa Pharma), Poctem Influenza A/B (Otsuka Pharma & Sysmex), BD Flu Examan (Nippon Beckton Dickinson), Quick Ex-Flu "Seiken" (Denka Seiken), Quick Vue Rapid SP Influ (DP Pharma Biomedical), and Rapid Testa FLU stick (Daiichi Pure Chemicals)--against influenza virus stocks, contained five vaccination strains (one A/H1N1, two A/H3N2, and two B) and six clinical strains (two A/H1N1, two A/H3N2, and two B). Minimum detection concentrations giving immunologically positive signals in serial dilution and RNA copies in positive dilution in real-time reverse transcriptase-polymerase chain reaction (RT-PCR) were assayed for all kits and virus stock combinations. RNA log10 copy numbers/mL in dilutions within detection limits yielded 5.68-7.02, 6.37-7,17, and 6.5-8.13 for A/H1N1, A/H3N2, and B. Statistically significant differences in sensitivity were observed between some kit combinations. Detection sensitivity tended to be relatively higher for influenza A than B virus. This is assumed due to different principles in kit methods, such as monoclonal antibodies, specimen-extraction conditions, and other unknown factors.
