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

Comparison of the Biofire FilmArray Respiratory Panel, Seegene AnyplexII RV16, and Argene for the detection of respiratory viruses.
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DOI:
10.1016/j.jcv.2018.07.002
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发表时间:
2018-09
期刊:
Journal of clinical virology : the official publication of the Pan American Society for Clinical Virology
影响因子:
--
通讯作者:
Tan TY
Tan TY
中科院分区:
其他
文献类型:
--
作者:
Chan M;Koo SH;Jiang B;Lim PQ;Tan TY

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FilmArray、AnyplexII和Argene平台的性能相当。UTM中的鼻咽拭子和气管内抽吸物是合适的样本类型。测试量是平台选择的主要决定因素。FilmArray自动化程度最高,通量最低,试剂成本最高。呼吸道感染是入院的常见原因,并且由于显著的发病率和死亡率而与巨大的经济负担相关。作为病理基础的广泛的微生物病原体使得呼吸道感染的诊断具有挑战性。分子诊断在灵敏度、覆盖范围、动手时间和获得结果的时间方面提供了当前基于血清学和培养的方法的优势。本研究旨在比较三种市售呼吸道病毒检测试剂盒的临床性能。基于平台间的常见重叠靶标,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)比较了FilmArray Respiratory Panel、AnyplexII RV 16和Argene的性能。将FilmArray检测的甲型流感病毒“不确定”和“无亚型”样本与实验室开发的甲型/B流感病毒检测进行进一步比较。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%)、合并感染检测以及流感与非流感病例的区分方面似乎相当。FilmArray检测的“不确定”和“无亚型”样本大多代表实验室开发检测的弱甲型流感病毒。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。冠状病毒HKU 1,其不是AnyplexII RV 16的靶向,被检测为OC 43。预期的测试量将是选择平台的主要决定因素。在这些平台中,FilmArray自动化程度最高,但通量最低,试剂成本最高。
Performance of FilmArray, AnyplexII, and Argene platforms was comparable. Nasopharyngeal swabs in UTM and endotracheal aspirates are suitable sample types. Test volume is the main determinant for the selection of platform. FilmArray is most automated, of lowest-throughput and has highest reagent cost. 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. This study aimed to compare the clinical performance of three commercial kits for respiratory viral detection. 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. 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.
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