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Godwin Ogbonna¹, Jodiann R Atienza², David W Singleton²

¹Department of Medical Affairs, QuidelOrtho Corporation, Rochester, NY, United States.

The journal of applied laboratory medicine

|December 12, 2024

概括

维特罗斯® B·R·A·H·M·S PCT 测定与 KRYPTOR PCT 测定显示出极好的一致性,这对于指导抗生素治疗和评估败血症患者的死亡风险非常有用.

科学领域:

临床化学临床化学
免疫诊断免疫诊断免疫诊断免疫诊断
关键护理医学关键护理医学

背景情况:

在下呼吸道感染和败血症的抗生素管理和风险分层中,前素 (PCT) 是至关重要的.
评估新的诊断试验对于优化患者护理至关重要.

研究的目的:

评估Vitros®免疫诊断产品B·R·A·H·M·S PCT测定 (Vitros PCT) 的临床和分析性能.
为了比较Vitros PCT与已建立的B·R·A·H·M·S PCTTM敏感的KRYPTORTM试验 (KRYPTOR PCT).

主要方法:

分析性能被评估为精度,空白限度 (LoB),检测限度 (LoD) 和量化限度 (LoQ).
在Vitros PCT和KRYPTOR PCT之间评估了方法比较和临床一致性.
根据PCT变化 (ΔPCT) 的28天全因死亡率分析了598名重症监护病房败血症患者的队列.

主要成果:

试管体PCT与KRYPTOR PCT (r=0.994,斜率=1.057) 的相关性非常好.
观察到高精度,实验室内变化系数从3.1%到6.4%不等.
在相关的临床决策切线 (0.1002.00 ng/mL) 中,试验之间的总体一致性超过97%,科恩的卡帕>0.91.
ΔPCT>80%的降低与28天全因死亡率的降低显著相关 (P=0.006).

结论:

维特罗斯PCT试验表现出强大的分析性能和与KRYPTOR PCT的良好一致性.
维生素PCT适用于治疗败血症的临床决策,包括抗生素治疗和风险评估.
使用Vitros PCT的ΔPCT测量有效预测严重败血症患者的28天死亡风险.

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