Jabor Antonín, Kubíček Zdenek, Labanczová Magda, Franeková Janka
Vnitr Lek. 2019 Summer;65(7-8):490-496.
Presepsin (soluble CD14 subtype) is a new biomarker of infection and sepsis. Correct interpretation is based on the knowledge of analytical reliability, biological variation, decision limits, and diagnostic effectivity.
The aim of the study was to verify analytical precision of presepsin measurements, to assess biological variation in healthy subjects, to verify reference and decision limits, to assess diagnostic effectivity, and to compare data with commonly used septic biomarkers - procalcitonin (PCT), CRP and interleukin 6 (IL6).
Analyti-cal precision (repeatability and intermediate precision) was estimated by repeated measurements of commercial control materials. Biological variation was evaluated in a group of 20 healthy volunteers in a 7-week experi-ment. Reference ranges were extracted from the literature and compared with data from healthy subjects.
Precisions of presepsin measurements were 2.0-4.0 % (“within-run”) and 6.1-9.5 % (“between-run”). Intraindividual biological variation of presepsin was 22.3 %, interindividual variation 20.8 %. Index of individuality was 1.07, reference change value (RCV - critical difference) was 72 %. Upper reference limit was around 180 ng/l.
Ana-lytical quality of presepsin measurement is suitable for clinical use. Biological variation parameters enable the use of reference limits, upper reference limit of presepsin is around 180 ng/l. None of the tested biomarkers has universal cut-off value, multiple biomarkers are needed and repeated measurements are advisable.
可溶性CD14亚型前降钙素是感染和脓毒症的一种新型生物标志物。正确解读基于对分析可靠性、生物学变异、决定限和诊断有效性的了解。
本研究旨在验证前降钙素测量的分析精密度,评估健康受试者的生物学变异,验证参考限和决定限,评估诊断有效性,并将数据与常用的脓毒症生物标志物——降钙素原(PCT)、C反应蛋白(CRP)和白细胞介素6(IL6)进行比较。
通过对商业对照材料的重复测量来估计分析精密度(重复性和中间精密度)。在一项为期7周的实验中,对20名健康志愿者进行了生物学变异评估。从文献中提取参考范围并与健康受试者的数据进行比较。
前降钙素测量的精密度为2.0 - 4.0%(批内)和6.1 - 9.5%(批间)。前降钙素的个体内生物学变异为22.3%,个体间变异为20.8%。个体性指数为1.07,参考变化值(RCV - 临界差值)为72%。参考上限约为180 ng/l。
前降钙素测量的分析质量适用于临床应用。生物学变异参数使得能够使用参考限,前降钙素的参考上限约为180 ng/l。所测试的生物标志物均无通用的临界值,需要多种生物标志物,且建议进行重复测量。