Multicenter reference limits of hs-cTnI and NT-proBNP in a Chinese cohort.

IF 2 Q2 MEDICINE, GENERAL & INTERNAL

Diagnosis Pub Date : 2026-05-05 DOI:10.1515/dx-2026-0045

Yuxin Xu, Qianjin Li, Huabin Xie, Li Hou, Poshi Xu, Huijun Cui, Xiaobo Chen, Xiaoyu Zhang, Ziyuan Peng, Houqing Zhou, Lixin Wang

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引用次数: 0

Abstract

Objectives: This study aimed to validate the analytical performance of high-sensitivity cardiac troponin I (hs-cTnI) and N-terminal pro-B-type natriuretic peptide (NT-proBNP) assays, and to establish age- and sex-specific reference intervals (RIs) using a large multicenter Chinese cohort.

Methods: hs-cTnI and NT-proBNP were measured on a fully automated chemiluminescence platform (Maglumi X8, Snibe, China). Analytical performance was validated following Clinical and Laboratory Standards Institute guidelines. Sex- and age-specific RIs for hs-cTnI (n=2,323) and NT-proBNP (n=2,333) were determined nonparametrically from IFCC-compliant cohorts across six Chinese provinces.

Results: Analytical validation confirmed high sensitivity, specificity, satisfactory linearity, and strong interference resistance of hs-cTnI and NT-proBNP. hs-cTnI demonstrated 3.19 % total imprecision near 99th percentile URLs and >99.5 % detectable rates (>LoD) in healthy individuals, meeting third-generation hs-cTn criteria. RIs were established stratified by age and sex. In plasma, RIs of hs-cTnI were 11.97 ng/L for males and 11.61 ng/L for females, while 97.5th percentile URLs of NT-proBNP were 145.00 ng/L overall, 113.63 ng/L for males, and 160.75 ng/L for females. Elevated hs-cTnI levels were observed in residents of Ningxia and in women with central obesity.

Conclusions: The Snibe hs-cTnI assay fulfills IFCC high-sensitivity criteria. Age- and sex-specific RIs of hs-cTnI and NT-proBNP were established from a large multicenter Chinese cohort, confirming their essential role in accurate cardiovascular risk stratification.

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hs-cTnI和NT-proBNP在中国队列中的多中心参考界限。

目的：本研究旨在验证高灵敏度心肌肌钙蛋白I （hs-cTnI）和n端前b型利钠肽（NT-proBNP）检测的分析性能，并通过大型多中心中国队列建立年龄和性别特异性参考区间（RIs）。方法：在全自动化学发光平台（Maglumi X8, Snibe, China）上测量hs-cTnI和NT-proBNP。根据临床和实验室标准协会的指导方针验证分析性能。从中国6个省份的ifcc依从队列中，非参数地确定了hs-cTnI （n= 2323）和NT-proBNP （n= 2333）的性别和年龄特异性RIs。结果：经分析验证，hs-cTnI和NT-proBNP具有较高的灵敏度、特异度、良好的线性关系和较强的抗干扰能力。hs-cTnI在第99百分位url附近显示3.19 %的总不精度，在健康个体中显示>99.5 %的检出率（>LoD），符合第三代hs-cTn标准。RIs按年龄和性别分层建立。在血浆中，男性hs-cTnI的RIs为11.97 ng/L，女性为11.61 ng/L，而NT-proBNP的97.5%的url为145.00 ng/L，男性为113.63 ng/L，女性为160.75 ng/L。在宁夏居民和中心性肥胖妇女中观察到hs-cTnI水平升高。结论：Snibe hs-cTnI检测符合IFCC的高灵敏度标准。hs-cTnI和NT-proBNP的年龄和性别特异性RIs是通过一个大型的中国多中心队列建立的，证实了它们在准确的心血管风险分层中的重要作用。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Diagnosis MEDICINE, GENERAL & INTERNAL-

CiteScore

7.20

自引率

5.70%

发文量

期刊介绍： Diagnosis focuses on how diagnosis can be advanced, how it is taught, and how and why it can fail, leading to diagnostic errors. The journal welcomes both fundamental and applied works, improvement initiatives, opinions, and debates to encourage new thinking on improving this critical aspect of healthcare quality.　 Topics: -Factors that promote diagnostic quality and safety -Clinical reasoning -Diagnostic errors in medicine -The factors that contribute to diagnostic error: human factors, cognitive issues, and system-related breakdowns -Improving the value of diagnosis – eliminating waste and unnecessary testing -How culture and removing blame promote awareness of diagnostic errors -Training and education related to clinical reasoning and diagnostic skills -Advances in laboratory testing and imaging that improve diagnostic capability -Local, national and international initiatives to reduce diagnostic error