Age- and sex-specific 99th percentile upper reference limits for high-sensitivity cardiac troponin T in Chinese older people: Real-world data mining

IF 2.5 3区 医学 Q2 MEDICAL LABORATORY TECHNOLOGY Clinical biochemistry Pub Date : 2024-04-04 DOI:10.1016/j.clinbiochem.2024.110762
Qian Zhang , Huiyi Chen , Meng Wang , Huiying Lai , Wensong Liu , Lijuan Wang , Jiaqi Zhang , Chuanbao Li , Weiyan Zhou
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Abstract

Background

This study aims to investigate the impact of age and sex on high-sensitivity cardiac troponin T (hs-cTnT) and establish 99th percentile upper reference limits (URLs) in older individuals utilizing large-scale real-world data.

Methods

40,530 outpatient hs-cTnT results were obtained from the laboratory database from January 1, 2018, to December 31, 2023. Our study included 4,199 elderly outpatients (aged ≥ 60) without cardiovascular disease or other heart-related chronic conditions. Nested analysis of variance was used to explore the necessity of partitioning reference intervals (RIs) by sex and age groups. RIs were established by the refineR algorithm and assessed based on ≤ 10% test results of validation data set outside the new RIs.

Results

RIs for hs-cTnT in the older population needed to be partitioned by sex and age groups ([standard deviation ratio] SDRage = 0.75; SDRsex = 0.49). URLs in older Chinese adults were 21.8 ng/L for males, 16.5 ng/L for females, and 20.7 ng/L for the overall participant group. URLs for males aged 60–69, 70–79, and ≥ 80 were 13.7, 19.4, and 31.0 ng/L, respectively. Female values were 10.1, 17.2, and 22.0 ng/L. Importantly, manufacturer-reported RIs do not suffice for Chinese individuals aged ≥ 70. Validation data showed that 2.7–5.2% of test results fell outside the new RIs, confirming the validity of the results.

Conclusion

This study establishes age- and sex-specific 99th percentile URLs for hs-cTnT in Chinese older individuals, thereby enhancing the accuracy of clinical assessments.

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中国老年人高敏心肌肌钙蛋白 T 的年龄和性别特异性第 99 百分位数参考上限:真实世界数据挖掘
背景本研究旨在利用大规模真实世界数据,调查年龄和性别对高敏心肌肌钙蛋白 T(hs-cTnT)的影响,并确定老年人的第 99 百分位数参考上限(URL)。方法从实验室数据库中获得了 40,530 份门诊病人 hs-cTnT 结果,时间为 2018 年 1 月 1 日至 2023 年 12 月 31 日。我们的研究包括 4199 名无心血管疾病或其他心脏相关慢性疾病的老年门诊患者(年龄≥ 60 岁)。我们采用嵌套方差分析来探讨按性别和年龄组划分参考区间(RIs)的必要性。结果 老年人群中 hs-cTnT 的参考区间需要按性别和年龄组进行划分([标准偏差比] SDRage = 0.75;SDRsex = 0.49)。中国老年人群中男性的URL值为21.8纳克/升,女性为16.5纳克/升,总体参与者为20.7纳克/升。年龄在 60-69 岁、70-79 岁和≥80 岁的男性的 URL 值分别为 13.7、19.4 和 31.0 纳克/升。女性的数值分别为 10.1、17.2 和 22.0 纳克/升。重要的是,对于年龄≥ 70 岁的中国人来说,制造商报告的 RIs 并不足够。验证数据显示,2.7%-5.2%的检测结果超出了新的RIs,这证实了结果的有效性。结论本研究建立了中国老年人hs-cTnT年龄和性别特异性第99百分位数URLs,从而提高了临床评估的准确性。
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来源期刊
Clinical biochemistry
Clinical biochemistry 医学-医学实验技术
CiteScore
5.10
自引率
0.00%
发文量
151
审稿时长
25 days
期刊介绍: Clinical Biochemistry publishes articles relating to clinical chemistry, molecular biology and genetics, therapeutic drug monitoring and toxicology, laboratory immunology and laboratory medicine in general, with the focus on analytical and clinical investigation of laboratory tests in humans used for diagnosis, prognosis, treatment and therapy, and monitoring of disease.
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