Comparative evaluation of STANDARD™ M10 Flu/RSV/SARS-CoV-2 and Savanna® Respiratory Viral Panel-4 assays for the rapid molecular diagnosis of influenza A/B virus, respiratory syncytial virus and SARS-CoV-2

IF 4 3区医学 Q2 VIROLOGY

Journal of Clinical Virology Pub Date : 2025-06-11 DOI:10.1016/j.jcv.2025.105827

Juulia Suominen, Raisa Loginov, Hannimari Kallio-Kokko

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引用次数: 0

Abstract

Background

The occurrence of respiratory infections caused by seasonal viruses influenza A/B, RSV and SARS-CoV-2 has increased the demand for rapid diagnostic assays. Comparative performance data of such assays is required.

Methods

In this retrospective study, clinical samples were tested with the STANDARD™ M10 Flu/RSV/SARS-CoV-2 test and the novel Savanna® Respiratory Viral Panel-4 tests, with Xpert® Xpress SARS-CoV-2/Flu/RSV as the reference. All three are RT-PCR tests suitable for point-of-care testing. Discordant results on the Savanna assay were retested with a new research-use-only protocol. Serial dilution testing for all three was performed with an external control.

Results

A total of 141 clinical samples, including 106 specimens positive for at least one virus, were analyzed. The M10 assay showed sensitivities of 100 %, 95.7 %, 97.1 % and 97.0 % for influenza A, B, RSV and SARS-CoV-2, respectively. The Savanna assay showed sensitivities of 92.6 %, 95.7 %, 100 % and 90.9 %. Both assays exhibited high specificity (≥99 %), except for the Savanna assay’s lower specificity for RSV (94.2 %) and SARS-CoV-2 (94.3 %). Savanna had a higher retest rate (5.0 %), while M10 produced only conclusive results. Serial dilution testing showed that Xpert detected three viruses more effectively than the other assays.

Conclusion

Both M10 and Savanna performed well for influenza A/B, but M10 was superior for RSV and SARS-CoV-2 due to false positives with Savanna. The new Savanna protocol showed promise, but further studies are required to confirm these findings. Xpert assay was the most sensitive for detecting low viral amounts.

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用于流感A/B病毒、呼吸道合胞病毒和SARS-CoV-2快速分子诊断的STANDARD™M10 Flu/RSV/SARS-CoV-2和Savanna®Respiratory Viral Panel-4检测的比较评价

季节性流感A/B、RSV和SARS-CoV-2引起的呼吸道感染的发生增加了对快速诊断检测的需求。需要这些分析的比较性能数据。方法以Xpert®Xpress SARS-CoV-2/Flu/RSV /RSV为对照，采用STANDARD™M10 Flu/RSV/SARS-CoV-2检测试剂盒和新型Savanna®Respiratory Viral Panel-4检测试剂盒对临床样本进行回顾性检测。这三种方法都是适用于即时检测的RT-PCR方法。用一种新的仅供研究使用的方案重新测试了稀树草原试验中不一致的结果。用外部对照对这三种药物进行连续稀释试验。结果共检出141份临床标本，其中至少一种病毒阳性106份。M10试验对甲型流感、乙型流感、RSV和SARS-CoV-2的敏感性分别为100%、95.7%、97.1%和97.7%。稀树草原试验的灵敏度分别为92.6%、95.7%、100%和90.9%。除了Savanna法对RSV（94.2%）和SARS-CoV-2（94.3%）的特异性较低外，两种检测方法均表现出高特异性（≥99%）。Savanna的复验率较高（5.0%），而M10仅产生结论性结果。系列稀释试验表明，Xpert比其他试验更有效地检测到三种病毒。结论M10和Savanna对流感A/B均有较好的检测效果，而M10对RSV和SARS-CoV-2均有较好的检测效果。新的热带草原方案显示出了希望，但需要进一步的研究来证实这些发现。Xpert法对检测低病毒量最敏感。

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来源期刊

Journal of Clinical Virology 医学-病毒学

CiteScore

22.70

自引率

1.10%

发文量

149

审稿时长

24 days

期刊介绍： The Journal of Clinical Virology, an esteemed international publication, serves as the official journal for both the Pan American Society for Clinical Virology and The European Society for Clinical Virology. Dedicated to advancing the understanding of human virology in clinical settings, the Journal of Clinical Virology focuses on disseminating research papers and reviews pertaining to the clinical aspects of virology. Its scope encompasses articles discussing diagnostic methodologies and virus-induced clinical conditions, with an emphasis on practicality and relevance to clinical practice. The journal publishes on topics that include: • new diagnostic technologies • nucleic acid amplification and serologic testing • targeted and metagenomic next-generation sequencing • emerging pandemic viral threats • respiratory viruses • transplant viruses • chronic viral infections • cancer-associated viruses • gastrointestinal viruses • central nervous system viruses • one health (excludes animal health)