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游离轻链参考区间的验证及其与年龄和估算肾小球滤过率的关联。

Validation of free light chain reference intervals and their association with age and eGFR.

作者信息

Wu Junyi, Zheng Xiaowen, Ge Yilin, Mu Li, Chen Siyu, Chen Ke, Yang Jiashu, Yuan Hui

机构信息

Department of Laboratory Medicine, Beijing Anzhen Hospital, Capital Medical University, Chaoyang District, Beijing 100029, China.

Shenzhen Goldsite Biology Technology Co., Ltd., Pingshan District, Shenzhen, Guangdong 518031, China.

出版信息

Clin Chim Acta. 2026 Jan 1;578:120494. doi: 10.1016/j.cca.2025.120494. Epub 2025 Jul 17.

Abstract

OBJECTIVES

To establish reference intervals (RIs) for serum free κ and λ light chains and the κ/λ ratio (FLCR) in healthy adults in China, and to evaluate the influence of age and estimated glomerular filtration rate (eGFR) METHODS: A total of 549 healthy adults with eGFR > 90 mL/min/1.73 m were enrolled. FLCs were measured using nephelometric assays (Goldsite Diagnostics). RIs of κ-FLC and λ-FLC were calculated based on the 2.5th to 97.5th percentiles(95 % interval),and FLCR was calculated on 100 % of this cohort. Additional subgroup analyses included individuals with reduced eGFR(60-89 mL/min/1.73 m)to assess the association between renal function and FLC concentrations. Spearman correlation and regression analyses were used to assess relationships between FLCs, FLCR, age, and eGFR.

RESULTS

This study RIs were determined: κ-FLC 4.27-35.05 mg/L, λ-FLC 12.61-34.09 mg/L, FLCR 0.15-1.58. All FLC parameters were inversely correlated with eGFR(p < 0.001) and increased with age(p < 0.001) CONCLUSIONS: RIs derived from other assays or cohorts may not be directly applicable to all settings. The influence of age and renal function in clinical practice, FLC results should be interpreted in combination with relevant clinical and laboratory information.

摘要

目的

建立中国健康成年人血清游离κ和λ轻链及κ/λ比值(FLCR)的参考区间(RIs),并评估年龄和估计肾小球滤过率(eGFR)的影响。方法:共纳入549例eGFR>90 mL/min/1.73 m²的健康成年人。使用散射比浊法(Goldsite诊断)测量游离轻链(FLCs)。基于第2.5至97.5百分位数(95%区间)计算κ-FLC和λ-FLC的RIs,并对该队列的100%计算FLCR。额外的亚组分析包括eGFR降低(60-89 mL/min/1.73 m²)的个体,以评估肾功能与FLC浓度之间的关联。采用Spearman相关性和回归分析评估FLCs、FLCR、年龄和eGFR之间的关系。

结果

确定了本研究的RIs:κ-FLC 4.27-35.05 mg/L,λ-FLC 12.61-34.09 mg/L,FLCR 0.15-1.58。所有FLC参数均与eGFR呈负相关(p<0.001),并随年龄增加而升高(p<0.001)。结论:源自其他检测方法或队列的RIs可能不适用于所有情况。在临床实践中,由于年龄和肾功能的影响,FLC结果应结合相关临床和实验室信息进行解释。

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