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现实世界中的游离κ轻链指数——我们跳过寡克隆带检测会遗漏临床相关信息吗?

Kappa Free Light Chain Index in the Real World-Do We Miss Clinically Relevant Information by Skipping Oligoclonal Banding?

作者信息

Hegen Harald, Schmidauer Martin, Auer Michael, Di Pauli Franziska, Berek Klaus, Walde Janette, Deisenhammer Florian

机构信息

Department of Neurology, Medical University of Innsbruck, Innsbruck, Austria.

Department of Statistics, Faculty of Economics and Statistics, University of Innsbruck, Innsbruck, Austria.

出版信息

Eur J Neurol. 2025 Sep;32(9):e70355. doi: 10.1111/ene.70355.

Abstract

BACKGROUND

No standardized strategy for integrating κ-free light chain (κ-FLC) index into routine cerebrospinal fluid (CSF) diagnostics has yet been established.

OBJECTIVE

To determine agreement between κ-FLC index and CSF-restricted oligoclonal bands (OCB), and to identify κ-FLC index range where second-line OCB testing is needed.

METHODS

A retrospective analysis was conducted in patients who had κ-FLC measurement between December 2023 and December 2024 at the Medical University of Innsbruck. κ-FLC in CSF and serum was determined by nephelometry; OCB by isoelectric focusing and immunoblotting. The threshold for positivity was defined as ≥ 3 CSF-restricted bands for OCB and ≥ 6.1 for κ-FLC index.

RESULTS

In 632 included samples, κ-FLC index ranged from 0.5 to 971. Among 213 samples with κ-FLC index ≥ 3.5, 180 (85%) samples had a positive κ-FLC index and 148 (69%) positive OCB. Thirty-four (16%) samples showed discordant results. One sample was OCB positive/κ-FLC index negative, showing markedly elevated serum κ-FLC values. Thirty-three samples were OCB negative/κ-FLC index positive; of those, 4 samples had isolated intrathecal immunoglobulin M or A synthesis, and the remaining 29 discordant samples showed a median κ-FLC index of 8.7 (75th percentile: 10.3). The predictive value for OCB positivity exceeded 95% in the case of κ-FLC index > 20.

CONCLUSION

κ-FLC index shows high agreement with OCB. Discordant results were largely confined to κ-FLC index between 3.5 and 20 ("gray zone"). A reflex approach, that is, initial screening with κ-FLC index and in case of values within the "gray zone" performing OCB, seems reasonable.

摘要

背景

尚未建立将游离κ轻链(κ-FLC)指数纳入常规脑脊液(CSF)诊断的标准化策略。

目的

确定κ-FLC指数与脑脊液限制性寡克隆带(OCB)之间的一致性,并确定需要进行二线OCB检测的κ-FLC指数范围。

方法

对2023年12月至2024年12月在因斯布鲁克医科大学进行κ-FLC测量的患者进行回顾性分析。通过比浊法测定脑脊液和血清中的κ-FLC;通过等电聚焦和免疫印迹法测定OCB。OCB阳性阈值定义为≥3条脑脊液限制性条带,κ-FLC指数阳性阈值定义为≥6.1。

结果

在纳入的632份样本中,κ-FLC指数范围为0.5至971。在213份κ-FLC指数≥3.5的样本中,180份(85%)样本κ-FLC指数阳性,148份(69%)样本OCB阳性。34份(16%)样本结果不一致。1份样本OCB阳性/κ-FLC指数阴性,血清κ-FLC值明显升高。33份样本OCB阴性/κ-FLC指数阳性;其中4份样本有孤立的鞘内免疫球蛋白M或A合成,其余29份不一致样本的κ-FLC指数中位数为8.7(第75百分位数:10.3)。当κ-FLC指数>20时,OCB阳性的预测值超过95%。

结论

κ-FLC指数与OCB显示出高度一致性。结果不一致主要局限于κ-FLC指数在3.5至20之间(“灰色区域”)。一种反射性方法,即先用κ-FLC指数进行初步筛查,若值在“灰色区域”内则进行OCB检测,似乎是合理的。

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