Author(s)

Zhang Lei ¹, Yang Feng ², Zhu Junzhe ³

Affiliation(s)

¹ Zhejiang Gongshang University, Hangzhou, Zhejiang, 310018, China
² Community Health Service Center, Hangzhou, Zhejiang, 310000, China
³ Wenzhou Medical University, Wenzhou, Zhejiang, 310000, China

Corresponding Author

Zhang Lei

ABSTRACT

This study assessed the clinical performance of the CITEST DIAGNOSTICS INC. Influenza A+B Rapid Test Cassette, an immunochromatographic assay designed for the qualitative detection of Influenza A and B viral antigens. Using reverse transcription polymerase chain reaction (RT-PCR) as the gold standard, the test's accuracy was evaluated across a range of human respiratory specimens, including nasopharyngeal swabs, throat swabs, and nasal aspirates. The evaluation involved a substantial cohort of samples: nasopharyngeal swabs (283 for Influenza A, 289 for Influenza B), throat swabs (212 for Influenza A, 232 for Influenza B), and nasal aspirates (289 for Influenza A, 255 for Influenza B). The rapid test demonstrated consistently high performance metrics regardless of the sample type. Sensitivity ranged from 94.2% to 100%, while specificity was maintained between 98.9% and 99.4%. Overall accuracy was calculated at 97.8% to 99.3. The high level of agreement with the reference RT-PCR method was further confirmed by Kappa values of 0.95 to 0.98. Additional analyses confirmed that the test is highly specific, showing no cross-reactivity with other common respiratory pathogens. The device also proved to be stable when stored at the recommended conditions of 2–30°C. In conclusion, the findings substantiate that this rapid test cassette is a robust, accurate, and practical diagnostic tool for the timely detection and differentiation of influenza A and B viruses, facilitating prompt clinical decision-making.

KEYWORDS

Influenza A; Influenza B; Rapid Test; Pathogen Specificity; Throat Swab; Point-of-Care Diagnostic; Immunochromatographic Assay; RT-PCR; Viral Antigen Detection

CITE THIS PAPER

Zhang Lei, Yang Feng, Zhu Junzhe, Performance Evaluation of Influenza A+B Rapid Test Cassette (Swab/Nasal Aspirate) via Clinical Validation. MEDS Clinical Medicine (2025) Vol. 6: 76-80. DOI: http://dx.doi.org/10.23977/medsc.2025.060511.

REFERENCES

[1] World Health Organization. Up to 650 000 people die of respiratory diseases linked to seasonal flu each year. 2017.
[2] Gorbiskopf LA, et al. Prevention and control of seasonal influenza with vaccines: recommendations of the advisory committee on immunization practices – United States, 2019–20 Influenza season. MMWR Recomm Rep. 2019;68(3):1–21.
[3] Paules C, Subbarao K. Influenza. Lancet. 2017;390(10095):697–708.
[4] Betts RF. Influenza virus. In: Mandell GL, Douglas RG, Bennett JE, editors. Principles and Practice of Infectious Diseases. 4th ed. New York: Churchill Livingstone; 1995. p. 1546–1567.
[5] Cho CH, Woo MK, Kim JY, et al. Evaluation of five rapid diagnostic kits for influenza A/B virus. J Virol Methods. 2013;187(1):51–56.
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