Fasano Tommaso, Fortunato Antonio, Giacomini Greta, Aimo Alberto, Moretti Marco, Viola Valentina, Sabbatinelli Jacopo, Farneti Giorgia, Maltoni Paolo, Biguzzi Rino, Sambri Vittorio, Di Marco Nadia, Ripoli Andrea, Clerico Aldo
Department of Laboratory and Transfusion Medicine, Hub Laboratory, AUSL Romagna, Cesena, Italy.
UOC Patologia Clinica, AST Ascoli-Piceno Marche, Ascoli Piceno, Italy.
Clin Chem Lab Med. 2025 Jan 7;63(4):821-830. doi: 10.1515/cclm-2024-0905. Print 2025 Mar 26.
The present multicenter study was designed to evaluate the analytical performance and the 99th percentile value of the reference healthy population i.e., 99th percentile upper reference limit of the MAGLUMI CLIA high-sensitivity cardiac troponin I (hs-cTnI) method.
Analytical performances and the 99th percentile URL value of the chemi-luminescent-immuno-assay (CLIA) method were evaluated using validated and standardized experimental protocols. Two cohorts including healthy adult individuals were enrolled. The first one included 989 blood donor volunteers (489 women and 500 men) aged 18-70 years (mean age 43 years, interquartile range 31-54 years). The second population included 47 healthy individuals (31 women and 16 men, mean age 78 years, interquartile range 73-81 years) aged≥71 years.
The distributions of hs-cTnI levels in both sexes are highly right-skewed, and men show significantly (p=0.0028) higher biomarker values than women. Moreover, in both sexes the hs-cTnI levels progressively increase after the 55 years. In the multivariate analysis (n=958), hs-cTnI was found to be significantly associated to NT-proBNP (p<0.0001), sex (p<0.0001) and BMI (p=0.0424). The 99th percentile URL values, calculated using the bootstrap method in the total reference heathy population (age≥18 years), were: Females (n=521): 5.93 ng/L (CI 95 % 5.29-8.48), Males (n=516): 9.79 ng/L (CI 95 % 6.37-17.41 ng/L), Total Population (n=1,037): 7.18 ng/L (CI 6.08-12.20 ng/L).
The MAGLUMI CLIA method met all the criteria for an hs-cTnI assay recommended by international guidelines. The hs-cTnI values measured with the CLIA method are higher in men compared to women at the same age, and also progressively increase after the age>55 years.
本多中心研究旨在评估MAGLUMI化学发光免疫分析法（CLIA）检测高敏心肌肌钙蛋白I（hs-cTnI）的分析性能以及参考健康人群的第99百分位数，即第99百分位数上限参考值。
采用经过验证和标准化的实验方案评估化学发光免疫分析法（CLIA）的分析性能和第99百分位数URL值。纳入了两个队列，均为健康成年个体。第一个队列包括989名年龄在18 - 70岁（平均年龄43岁，四分位间距31 - 54岁）的献血志愿者（489名女性和500名男性）。第二个队列包括47名年龄≥71岁（平均年龄78岁，四分位间距73 - 81岁）的健康个体（31名女性和16名男性）。
hs-cTnI水平在两性中的分布均呈高度右偏态，男性的生物标志物值显著高于女性（p = 0.0028）。此外，在两性中，hs-cTnI水平在55岁后逐渐升高。在多变量分析（n = 958）中，发现hs-cTnI与N末端B型利钠肽原（NT-proBNP）（p < 0.0001）、性别（p < 0.0001）和体重指数（BMI）（p = 0.0424）显著相关。在整个参考健康人群（年龄≥18岁）中使用自助法计算的第99百分位数URL值为：女性（n = 521）：5.93 ng/L（95%置信区间5.29 - 8.48），男性（n = 516）：9.79 ng/L（95%置信区间6.37 - 17.41 ng/L），总人群（n = 1037）：7.18 ng/L（95%置信区间6.08 - 12.20）。
MAGLUMI CLIA方法符合国际指南推荐的hs-cTnI检测的所有标准。用CLIA方法测得的hs-cTnI值在同一年龄段男性中高于女性，并且在55岁以后也逐渐升高。
