Cao Jinghao, Chen Xi, Zhou Yu, Lu Yajuan, Deng Aoli, Li Sainan, Chen Yuhan, Du Jing, Xia Jun
Laboratory Medicine Center, Department of Clinical Laboratory, Zhejiang Provincial People's Hospital (Affiliated People's Hospital), Hangzhou Medical College, Hangzhou, 310014, Zhejiang, China.
Eur J Med Res. 2025 Aug 4;30(1):706. doi: 10.1186/s40001-025-02984-8.
Multiple myeloma (MM) is a malignant bone marrow disorder characterized by the abnormal proliferation of plasma cells. The measurement of serum free light chains (FLC) is a standard diagnostic and management tool for MM. The International Myeloma Working Group utilizes the iFLC/uFLC ratio to distinguish smoldering multiple myeloma (SMM) from active MM requiring therapeutic intervention.
We employed a novel serum free light chain (FLC) assay kit, FLCCheck, to evaluate its consistency with established traditional methods.
We collected 115 samples from 72 patients and tested them using FLCCheck, Freelite, and N Latex FLC. The data obtained from each method were analyzed using Passing-Bablok and Bland-Altman methods, and a chi-square analysis was performed to assess the consistency between the tests. Finally, we used the three methods to calculate and analyze the κ/λ ratio for two patients during their clinical treatment.
The FLCCheck assay demonstrated a validated linear range, high precision, and strong resistance to interference for both κ and λ light chain detection. By incorporating blocking peptides to reduce cross-reactivity, we improved the reliability of the diluted recovery by more than twofold. The results indicate that FLCCheck exhibits the highest correlation with N Latex FLC, particularly regarding the κ/λ ratio and κ FLC. We also monitored the therapeutic efficacy in MM patients, the results indicated that the three methods followed comparable trends; yet, FLCCheck distinguished itself by demonstrating a more rapid response with the highest amplitude variation.
Our findings show satisfactory consistency between the three FLC testing methods, but their interchangeability is not recommended. Consistent use of the same assay method across all reports is essential. The development of new FLC detection methods is valuable for optimizing disease monitoring, prognosis, and the management of multiple myeloma and related diseases.
多发性骨髓瘤（MM）是一种恶性骨髓疾病，其特征为浆细胞异常增殖。血清游离轻链（FLC）检测是MM的标准诊断和管理工具。国际骨髓瘤工作组利用iFLC/uFLC比值来区分冒烟型多发性骨髓瘤（SMM）与需要治疗干预的活动性MM。
我们使用一种新型血清游离轻链（FLC）检测试剂盒FLCCheck，评估其与既定传统方法的一致性。
我们从72例患者中收集了115份样本，并使用FLCCheck、Freelite和N Latex FLC进行检测。使用Passing-Bablok法和Bland-Altman法对各方法获得的数据进行分析，并进行卡方分析以评估检测之间的一致性。最后，我们使用这三种方法对两名患者临床治疗期间的κ/λ比值进行计算和分析。
FLCCheck检测对κ和λ轻链检测均显示出验证的线性范围、高精度和强抗干扰能力。通过加入封闭肽以降低交叉反应性，我们将稀释回收率的可靠性提高了两倍多。结果表明，FLCCheck与N Latex FLC的相关性最高，尤其是在κ/λ比值和κ FLC方面。我们还监测了MM患者的治疗效果，结果表明这三种方法呈现出可比的趋势；然而，FLCCheck表现突出，显示出更快的反应和最大的幅度变化。
我们的研究结果表明三种FLC检测方法之间具有令人满意的一致性，但不建议它们相互替代使用。在所有报告中始终使用相同的检测方法至关重要。新型FLC检测方法的开发对于优化多发性骨髓瘤及相关疾病的病情监测、预后评估和管理具有重要价值。
