Author(s)

Lei Zhang ¹, Feng Yang ², Junzhe Zhu 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

Lei Zhang

ABSTRACT

The SARS-CoV-2/Influenza A+B/RSV Antigen Combo Rapid Test is a chromatographic immunoassay designed for the qualitative detection of SARS-CoV-2 nucleocapsid protein, Influenza A, Influenza B and Respiratory Syncytial Virus (RSV) antigens in human nasopharyngeal and nasal swab specimens. This study aims to systematically evaluate the performance characteristics, including sensitivity, specificity, accuracy and clinical utility, of this combo test compared to reverse transcription - polymerase chain reaction (RT-PCR), the gold standard method. A total of 2286 specimens (1369 nasopharyngeal swabs and 917 nasal swabs) from individuals with suspected respiratory viral infections were tested. The results demonstrated high relative sensitivity (ranging from 92.9% to 97.0%), specificity (ranging from 96.2% to 99.7%) and accuracy (ranging from 95.9% to 99.2%) across different viruses and specimen types. The test showed no cross-reactivity with other common respiratory viruses and bacteria and its limit of detection was determined to be 100 pg/mL for SARS-CoV-2, 1.5×10⁵ TCID₅₀/Test for Influenza A, 1.0×10⁵ TCID₅₀/Test for Influenza B and 1.2×10⁴ TCID₅₀/Test for RSV. Intra-assay and inter-assay precision were excellent, with >99% correct identification of specimens. These findings indicate that the SARS-CoV-2/Influenza A+B/RSV Antigen Combo Rapid Test is a reliable, rapid and practical tool for the simultaneous detection of multiple respiratory viral antigens, which can aid in timely clinical decision-making and infection control.

KEYWORDS

SARS-Cov-2; Influenza A; Influenza B; RSV; Antigen Combo Rapid Test; Chromatographic Immunoassay; Respiratory Viral Infections

CITE THIS PAPER

Lei Zhang, Feng Yang, Junzhe Zhu, A Multicenter Study on the Clinical Utility of a Rapid Antigen Combo Test for Concurrent Detection of SARS-CoV-2, Influenza A, Influenza B, and RSV. MEDS Clinical Medicine (2025) Vol. 6: 44-48. DOI: http://dx.doi.org/10.23977/medsc.2025.060410.

REFERENCES

[1] World Health Organization. Coronavirus disease 2019 (COVID-19) situation report. 
[2] Mandal S, et al. Clinical manifestations of COVID-19, influenza, and respiratory syncytial virus infection: A comparative analysis. Journal of Medical Virology, 2021, 93(6): 3456-3463.
[3] Jefferson T, et al. Antiviral treatment for influenza: A systematic review and meta-analysis. The Lancet Infectious Diseases, 2014, 14(12): 1274-1285.
[4] Corman VM, et al. Detection of 2019 novel coronavirus (2019-nCoV) by real-time RT-PCR. Eurosurveillance, 2020, 25(3): 2000045.
[5] O'Farrell N, et al. Lateral flow immunoassays for infectious diseases: A review. Analytical and Bioanalytical Chemistry, 2009, 393(3): 669-682.
[6] Baden LR, et al. Performance of a rapid antigen test for detection of SARS-CoV-2. New England Journal of Medicine, 2021, 384(16): 1577-1579.
[7] Hayden FG, et al. Use of oseltamivir for treatment and prevention of influenza in adults. Clinical Infectious Diseases, 2000, 31(1): 108-119.
[8] Hall CB, et al. The burden of respiratory syncytial virus infection in young children. New England Journal of Medicine, 2009, 360(6): 588-598.
[9] Aiello AE, et al. Comparison of nasal and nasopharyngeal swabs for detection of SARS-CoV-2. JAMA Internal Medicine, 2020, 180(10): 1331-1333.
[10] La Scola B, et al. Analytical and clinical performances of six SARS-CoV-2 antigen detection tests. Clinical Microbiology and Infection, 2020, 26(11): 1477-1481.
[11] World Health Organization. RT-PCR testing for COVID-19: Interim guidance. 
[12] Tegally H, et al. Detection of a SARS-CoV-2 variant of concern in South Africa. Nature, 2021, 592 (7854): 438-443.
[13] Bustin SA, et al. The MIQE guidelines: Minimum information for publication of quantitative real-time PCR experiments. Clinical Chemistry, 2009, 55 (4): 611-622.

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