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FilmArray RP 2.1与靶向新一代测序在上呼吸道感染中的比较性能评估

Comparative performance evaluation of FilmArray RP 2.1 and targeted next-generation sequencing in upper respiratory tract infections.

作者信息

Jin Wenxiang, Dai Zehan, Zhu Pengyuan, Ma Oliver, Li Jiahao, Kong Ava, Wu Junbin, Liu Feifei, Li Miaozhi, Du Zixin, Xue Dan, Yang Ganqiang, Ye Nafen, Lo Chunleung, Hu Chaohui, Zhang Lei

机构信息

Department of Laboratory Diagnosis, KingMed Diagnostics, Guangzhou, Guangdong, China.

Research and Development Department, Guangzhou KingCreate Biotechnology Co., Ltd, Guangzhou, China.

出版信息

Front Cell Infect Microbiol. 2025 Jul 24;15:1610445. doi: 10.3389/fcimb.2025.1610445. eCollection 2025.

Abstract

INTRODUCTION

Upper respiratory tract infections (URTIs) represent a significant global health burden, impacting patient morbidity and quality of life. The implementation of accurate pathogen detection methods is crucial for precise diagnosis and effective clinical management of URTIs. This study evaluates the clinical performance of targeted next-generation sequencing (tNGS) as a diagnostic tool for comprehensive identification of URTI-associated pathogens.

METHODS

A total of 190 nasopharyngeal swab specimens from patients were enrolled for the study. These specimens underwent pathogen identification using both tNGS and the FilmArray respiratory panel. The results obtained from these two methods were then compared.

RESULTS

Overall, tNGS identified 164 positive samples, compared to 91 positives identified by FilmArray. Regarding the shared target species or subtypes, tNGS identified 97 positive samples, whereas the FilmArray respiratory panel detected 88 positives out of 190 specimens. tNGS identified a diverse array of 34 different pathogens, significantly surpassing the 12 pathogens identified by the FilmArray panel. The detection rates for tNGS and FilmArray were 51.05% (97/190) and 46.32% (88/190), respectively. Statistical analysis revealed no significant difference in the detection rates of 10 specific respiratory pathogens (with ≥3 positives). Furthermore, the overall pathogen detection accuracy of tNGS was determined to be 90.16% (95% = 83.45%94.81%), with a sensitivity of 95.45% (88.77%98.75%).

CONCLUSIONS

The tNGS method demonstrates broader pathogen detection capability compared to the FilmArray, achieving a higher positive detection rate in upper respiratory tract infections. It demonstrates high accuracy and sensitivity, offering a viable and rapid diagnostic approach for upper respiratory tract infections.

摘要

引言

上呼吸道感染(URTIs)是一项重大的全球健康负担,影响患者的发病率和生活质量。实施准确的病原体检测方法对于上呼吸道感染的精确诊断和有效的临床管理至关重要。本研究评估了靶向新一代测序(tNGS)作为一种诊断工具用于全面鉴定与上呼吸道感染相关病原体的临床性能。

方法

本研究共纳入了190例患者的鼻咽拭子标本。这些标本同时采用tNGS和FilmArray呼吸道检测板进行病原体鉴定。然后比较这两种方法获得的结果。

结果

总体而言,tNGS鉴定出164份阳性样本,而FilmArray鉴定出91份阳性样本。对于共同的目标物种或亚型,tNGS鉴定出97份阳性样本,而FilmArray呼吸道检测板在190份标本中检测到88份阳性样本。tNGS鉴定出34种不同的病原体,显著超过FilmArray检测板鉴定出的12种病原体。tNGS和FilmArray的检测率分别为51.05%(97/190)和46.32%(88/190)。统计分析显示,10种特定呼吸道病原体(阳性数≥3)的检测率无显著差异。此外,tNGS的总体病原体检测准确率为90.16%(95% = 83.45%94.81%),灵敏度为95.45%(88.77%98.75%)。

结论

与FilmArray相比,tNGS方法显示出更广泛的病原体检测能力,在上呼吸道感染中实现了更高的阳性检测率。它具有高准确性和灵敏度,为上呼吸道感染提供了一种可行且快速的诊断方法。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/5d60/12329660/ce89a73d449e/fcimb-15-1610445-g001.jpg

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