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

This study provides a comprehensive clinical evaluation of a multiplex immunochromatographic assay for the simultaneous qualitative detection of six major respiratory pathogens (SARS-CoV-2, Influenza A+B, RSV, Adenovirus, M. pneumoniae) from nasopharyngeal swabs. Using RT-PCR as the reference standard, diagnostic accuracy was evaluated across a large cohort of clinical specimens (n=3781). The assay demonstrated consistently high performance for all targets. For SARS-CoV-2, relative sensitivity and specificity were 96.4–98.2% and 99.0–>99.9%, respectively. Sensitivities for Influenza A and B were 94.1–95.2% and 92.9–94.3%, with specificities of 99.1–100%. For RSV, Adenovirus, and M. pneumoniae, sensitivities ranged from 94.3–98.2%, 96.9–98.1%, and 91.8–94.3%, while specificities were 96.2–100%, 97.4–100%, and 96.8–98.7%, respectively. Overall accuracy exceeded 95% for all pathogens across three independent clinical sites. The test showed no cross-reactivity with a panel of common respiratory microorganisms and exhibited robust precision. These results confirm that this multiplex rapid test is a reliable, accurate, and practical point-of-care tool for the timely detection and differentiation of key respiratory pathogens, supporting prompt clinical decision-making and patient management.

KEYWORDS

SARS-CoV-2; Influenza A; Influenza B; RSV; Adenovirus; M. pneumoniae; Rapid Antigen Test; Multiplex Detection; Nasopharyngeal Swab; Point-of-Care Diagnostics; RT-PCR

CITE THIS PAPER

Lei Zhang, Feng Yang, Junzhe Zhu, Clinical Performance Evaluation of the Newlink L11-RTA05C5 SARS-CoV-2/Influenza A+B/RSV/Adenovirus/M.pneumoniae Antigen Combo Rapid Test (Nasopharyngeal Swab): A Multicenter Study. MEDS Clinical Medicine (2025) Vol. 6: 177-182. DOI: http://dx.doi.org/10.23977/medsc.2025.060526.

REFERENCES

[1] GBD 2019 Respiratory Infections Collaborators. (2022). Global mortality associated with 33 bacterial pathogens in 2019: a systematic analysis for the Global Burden of Disease Study 2019. The Lancet Infectious Diseases, 22(12), 1626-1647.
[2] Tang, YW, Schmitz, JE, Persing, DH, Stratton, CW. Laboratory Diagnosis of COVID-19: Current Issues and Challenges. Journal of Clinical Microbiology, 2020,58(6), e00512-e00520.
[3] Mahony, JB. Detection of respiratory viruses by molecular methods. Clinical Microbiology Reviews, 2008,21(4), 716-747.
[4] Hanson, KE, Caliendo, AM, et al. The Infectious Diseases Society of America guidelines on the diagnosis of COVID-19: molecular diagnostic testing (January 2021). Clinical infectious diseases, 2024,78(7), e170-e207.
[5] Leland, DS, Ginocchio, CC. Role of cell culture for virus detection in the age of technology. Clinical Microbiology Reviews, 2007,20(1), 49-78.
[6] Dinnes, J, Sharma, P, Berhane, S, et al. Rapid, point‐of‐care antigen tests for diagnosis of SARS‐CoV‐2 infection. Cochrane Database of Systematic Reviews, 2022, (7).
[7] Brendish, NJ, Malachira, AK, Clark, TW. Molecular point-of-care testing for respiratory viruses versus routine clinical care in adults with acute respiratory illness: a systematic review and meta-analysis. The Lancet Respiratory Medicine, 2017,5(5), 401-411.
[8] World Health Organization. (2020). Antigen-detection in the diagnosis of SARS-CoV-2 infection using rapid immunoassays: interim guidance.
[9] Ramanan, P, Bryson, AL, Binnicker, MJ, et al. Syndromic Panel-Based Testing in Clinical Microbiology. Clinical Microbiology Reviews, 2017,31(1), e00017-e00024.
[10] Falsey, AR, Walsh, EE. Impact of Rapid Molecular Respiratory Virus Testing on Clinical Outcomes and Antimicrobial Use in Hospitalized Adults: A Systematic Review. The Journal of Infectious Diseases, 2022,225(10), 1707-1713.

Sponsors, Associates, and Links

---

• Journal of Neurobiology and Genetics
  
  
• Medical Imaging and Nuclear Medicine
  
  
• Bacterial Genetics and Ecology
  
  
• Transactions on Cancer
  
  
• Journal of Biophysics and Ecology
  
  
• Journal of Animal Science and Veterinary
  
  
• Academic Journal of Biochemistry and Molecular Biology
  
  
• Transactions on Cell and Developmental Biology
  
  
• Rehabilitation Engineering & Assistive Technology
  
  
• Orthopaedics and Sports Medicine
  
  
• Hematology and Stem Cell
  
  
• Journal of Intelligent Informatics and Biomedical Engineering
  
  
• MEDS Basic Medicine
  
  
• MEDS Stomatology
  
  
• MEDS Public Health and Preventive Medicine
  
  
• MEDS Chinese Medicine
  
  
• Journal of Enzyme Engineering
  
  
• Advances in Industrial Pharmacy and Pharmaceutical Sciences
  
  
• Bacteriology and Microbiology
  
  
• Advances in Physiology and Pathophysiology
  
  
• Journal of Vision and Ophthalmology
  
  
• Frontiers of Obstetrics and Gynecology
  
  
• Digestive Disease and Diabetes
  
  
• Advances in Immunology and Vaccines
  
  
• Nanomedicine and Drug Delivery
  
  
• Cardiology and Vascular System
  
  
• Pediatrics and Child Health
  
  
• Journal of Reproductive Medicine and Contraception
  
  
• Journal of Respiratory and Lung Disease
  
  
• Journal of Bioinformatics and Biomedicine