对BIOFIRE SPOTFIRE呼吸系统面板的临床评估
Wai-Sing Chan1, Christy Wing-Yiu Ho1, Tsz-Ching Chan1
1Department of Pathology, Hong Kong Sanatorium & Hospital, Hong Kong SAR, China.
Viruses
|April 27, 2024
概括
新的BIOFIRE SPOTFIRE呼吸 (R) 板为15种呼吸道病原体提供了快速的15分钟多重PCR测试. 它的性能与现有的面板相提并论,使其成为呼吸系统疾病诊断的有希望的工具.
科学领域:
- 临床微生物学 临床微生物学
- 传染性疾病 传染性疾病
- 分子诊断学 分子诊断
背景情况:
- 生物火 SPOTFIRE 呼吸系统 (R) 面板是一种新的体外诊断试验.
- 它使用PCR技术针对15种常见的呼吸道病原体.
- 该面板拥有快速的15分钟运行时间,比现有市场选项快得多.
研究的目的:
- 为了评估BIOFIRE SPOTFIRE呼吸 (R) 板的临床性能.
- 将其精度与已建立的FilmArray呼吸系统2.1加 (RP2.1plus) 面板进行比较.
- 评估其在近期COVID-19后流感季节的有用性.
主要方法:
- 使用151个呼吸道样本 (133个上呼吸道,13个下呼吸道) 和5个外部质量评估程序样本进行性能评估.
- 与FilmArray呼吸系统2.1plus (RP2.1plus) 面板进行比较,作为标准的护理.
- 对不同的结果进行了不一致的分析.
主要成果:
- 在133个上呼吸道标本中的109个 (81.95%) 与RP2.1plus.plus相比,观察到完全一致.
- 该SPOTFIRE R小组在15个标本中发现了额外的病原体,而RP2.1plus在3个标本中发现了更多的病原体.
- 每个目标的阴性和阳性百分比一致性在92.86-100%之间,腺病毒PPA为88.24%. 所有下呼吸道和EQAP样本显示完全一致.
结论:
- 在BIOFIRE SPOTFIRE呼吸 (R) 面板显示性能与FilmArray呼吸2.1加 (RP2.1plus) 面板相比.
- 它的快速周转时间在临床环境中提供了显著的优势.
- 该面板是检测多种呼吸道病原体的可靠工具.
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