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比较生物梅里埃 FilmArray 呼吸道Panel 检测试剂盒、赛沛 AnyplexII RV16 和 Argene 检测试剂盒在呼吸道病毒检测中的性能。

Comparison of the Biofire FilmArray Respiratory Panel, Seegene AnyplexII RV16, and Argene for the detection of respiratory viruses.

机构信息

Department of Laboratory Medicine, Changi General Hospital, Singapore.

Clinical Trials & Research Unit, Changi General Hospital, Singapore.

出版信息

J Clin Virol. 2018 Sep;106:13-17. doi: 10.1016/j.jcv.2018.07.002. Epub 2018 Jul 6.

Abstract

BACKGROUND

Respiratory infections are common reasons for hospital admission, and are associated with enormous economic burden due to significant morbidity and mortality. The wide spectrum of microbial agents underlying the pathology renders the diagnosis of respiratory infections challenging. Molecular diagnostics offer an advantage to the current serological and culture-based methods in terms of sensitivity, coverage, hands-on time, and time to results.

OBJECTIVES

This study aimed to compare the clinical performance of three commercial kits for respiratory viral detection.

STUDY DESIGN

The performance of FilmArray Respiratory Panel, AnyplexII RV16, and Argene was compared using clinical respiratory samples (n = 224, comprising 189 nasopharyngeal swabs in Universal Transport Medium (UTM) and 35 endotracheal aspirates), based on common overlapping targets across the platforms. Influenza A "equivocal" and "no-subtype" samples by FilmArray were further compared to a laboratory-developed Influenza A/B test.

RESULTS AND CONCLUSIONS

The overall performance of all three platforms appeared to be comparable with regards to sensitivities (95.8-97.9%) and specificities (96.1-98.0%), detection of coinfections, and distinguishment of influenza from non-influenza cases. "Equivocal" and "no-subtype" samples by FilmArray mostly represented weak Influenza A by laboratory-developed test. Lower respiratory tract samples had comparable final-run success-rates and discordant-rates as compared to UTM. Coronavirus HKU1, which was not targeted by AnyplexII RV16, were detected as OC43. The expected test volume would be the main determinant for the selection of platform. Among the platforms, the FilmArray is the most automated but is of the lowest-throughput and has the highest reagent cost.

摘要

背景

呼吸道感染是住院的常见原因,由于发病率和死亡率高,给经济带来了巨大负担。导致呼吸道感染的微生物病原体范围广泛,这使得呼吸道感染的诊断具有挑战性。与目前基于血清学和培养的方法相比,分子诊断在灵敏度、覆盖范围、操作时间和结果时间方面具有优势。

目的

本研究旨在比较三种商业试剂盒在呼吸道病毒检测方面的临床性能。

研究设计

使用临床呼吸道样本(n=224,包括 189 份通用转运培养基(UTM)中的鼻咽拭子和 35 份气管内抽吸物),基于三个平台共有的常见重叠靶点,比较 FilmArray 呼吸道检测试剂盒、AnyplexII RV16 试剂盒和 Argene 试剂盒的性能。进一步比较 FilmArray 检测为“不确定”和“无亚型”的流感 A 样本与实验室开发的流感 A/B 检测。

结果与结论

所有三个平台的总体性能在灵敏度(95.8-97.9%)和特异性(96.1-98.0%)、检测合并感染、以及区分流感与非流感病例方面似乎相当。FilmArray 检测为“不确定”和“无亚型”的样本主要代表实验室开发的检测为弱阳性的流感 A。与 UTM 相比,下呼吸道样本的最终运行成功率和不一致率相当。AnyplexII RV16 未检测到的 HKU1 冠状病毒被检测为 OC43。预期的检测量将是选择平台的主要决定因素。在这些平台中,FilmArray 是最自动化的,但通量最低,试剂成本最高。

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