对Xpert Xpress CoV-2/流感/RSV plus和Alinity m Resp-4-Plex 试验的临床评估
Wai-Sing Chan1, Kan-Pui Wong1, Siu-Kei Yau1
1Department of Pathology, Hong Kong Sanatorium & Hospital, Hong Kong SAR, China.
Diagnostics (Basel, Switzerland)
|April 13, 2024
概括
两个快速诊断试验,Xpert Xpress CoV-2/Flu/RSV plus和Alinity m Resp-4-Plex,在检测呼吸道病毒方面表现出高准确度. 这两种分析都与标准护理方法有很好的一致性,加强了诊断能力.
科学领域:
- 临床诊断 临床诊断 临床诊断
- 分子生物学分子生物学
- 传染病检测 传染病检测
背景情况:
- 准确和快速检测呼吸道病毒对于患者管理和公共卫生至关重要.
- SARS-CoV-2 与其他呼吸道病原体 (如流感和RSV) 的共同循环需要可靠的多重诊断工具.
研究的目的:
- 为了评估和比较两个多重测试的性能:Xpert Xpress CoV-2/Flu/RSV plus和Alinity m Resp-4-Plex.
- 评估它们与检测SARS-CoV-2,流感和RSV在呼吸器样本中的标准护理 (SOC) 方法的一致性.
主要方法:
- 使用167个标本 (158个人类呼吸道,9个EQAP样本) 的性能评估.
- 对比 Xpert Xpress CoV-2/流感/RSV plus 和 Alinity m Resp-4-Plex 与 SOC 方法的比较.
- 对正百分比协议 (PPA),负百分比协议 (NPA) 和科恩的卡帕系数进行评估.
- 实验检测极限 (LoD) 和值周期 (Ct) 值相关性的确定.
主要成果:
- 专家Xpress CoV-2/流感/RSV plus与SOC方法 (100%PPA和NPA) 完全一致 (科恩 κ: 1).
- 与SOC方法 (100%的PPA,88.46%的NPA) 达成几乎完美的一致 (科恩 κ:0.92).
- 这两种测试均具有相似的SARS-CoV-2LoD (25拷贝/毫升),并显示出强大的Ct值相关性 (R2:0.92-0.97).
结论:
- 两种Xpert Xpress CoV-2/Flu/RSV plus和Alinity m Resp-4-Plex测定都具有高度准确性,可与呼吸道病毒检测的SOC方法相比较.
- 这些快速检测可以提高诊断能力,以管理流行后的共同循环呼吸道病毒.
- 它们的实施可以支持及时的临床决策和感染控制战略.
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