Department of Neurology, University Medicine Greifswald, Greifswald.
Institute of Clinical Chemistry and Laboratory Medicine, University Medicine Greifswald, Greifswald.
Eur J Neurol. 2018 Sep;25(9):1134-1139. doi: 10.1111/ene.13667. Epub 2018 May 17.
The gold standard for detection of intrathecal immunoglobulin synthesis is the measurement of oligoclonal bands (OCB). In the diagnosis of multiple sclerosis, the kappa free light chains (KFLC) index has a similar sensitivity and specificity as OCB. This study investigated whether determination of the KFLC index could be used to predict the presence of OCB.
The KFLC index was determined prospectively from 295 paired serum and cerebrospinal fluid samples. KFLC were determined by nephelometry using the N Latex FLC kappa kit (Siemens Healthcare Diagnostics Products GmbH) on the BN Prospec analyzer (Siemens Healthcare Diagnostics Products GmbH) (cohort I). A cut-off value was determined using receiver operating characteristic analysis in relation to OCB positivity. These results were validated prospectively in 96 samples (cohort II) as well as retrospectively in samples of 46 patients known to be OCB positive (cohort III). We also compared the agreement of two commercially available nephelometric KFLC assays.
In cohort I, a KFLC index of 3.61 yielded 100% sensitivity and 88% specificity. Prospective validation of this cut-off value in cohort II showed 92% sensitivity and 96% specificity. In cohort III, a sensitivity of 93% was achieved. Comparison of Siemens and Binding Site (Birmingham, UK) assays revealed good agreement (r = 0.86).
The KFLC index with a cut-off value of 3.61 had high diagnostic accuracy to predict immunoglobulin G synthesis via OCB analysis. Determination of the KFLC index provided a quantitative parameter that could be used as an initial diagnostic step in inflammatory central nervous system disorders before measuring OCB.
检测鞘内免疫球蛋白合成的金标准是寡克隆带(OCB)的测量。在多发性硬化症的诊断中,κ 游离轻链(KFLC)指数与 OCB 具有相似的灵敏度和特异性。本研究旨在探讨 KFLC 指数的测定是否可用于预测 OCB 的存在。
前瞻性地从 295 对血清和脑脊液样本中确定 KFLC 指数。使用 N Latex FLC kappa 试剂盒(Siemens Healthcare Diagnostics Products GmbH)通过散射比浊法在 BN Prospec 分析仪(Siemens Healthcare Diagnostics Products GmbH)上(队列 I)测定 KFLC。使用受试者工作特征分析确定与 OCB 阳性相关的截断值。这些结果在 96 个样本(队列 II)中进行了前瞻性验证,并在已知 OCB 阳性的 46 个患者的样本中进行了回顾性验证(队列 III)。我们还比较了两种市售散射比浊法 KFLC 检测的一致性。
在队列 I 中,KFLC 指数为 3.61 时具有 100%的灵敏度和 88%的特异性。在队列 II 中前瞻性验证该截断值时,灵敏度为 92%,特异性为 96%。在队列 III 中,灵敏度为 93%。西门子和 Binding Site(英国伯明翰)检测方法的比较显示出良好的一致性(r = 0.86)。
KFLC 指数截断值为 3.61 时,具有预测 OCB 分析中 IgG 合成的高诊断准确性。KFLC 指数的测定提供了一个定量参数,可在测量 OCB 之前作为炎症性中枢神经系统疾病的初始诊断步骤使用。