血清总κ/λ比值对 M 蛋白血症的预警值。

Warning values of serum total kappa/lambda ratio for M-proteinemia.

机构信息

Department of Clinical Laboratory, The First Affiliated Hospital of Soochow University, Suzhou, 215006, Jiangsu, China.

出版信息

BMC Immunol. 2024 Oct 30;25(1):73. doi: 10.1186/s12865-024-00664-6.

DOI:10.1186/s12865-024-00664-6

PMID:39478462

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC11523637/

Abstract

BACKGROUND

To introduce the serum total kappa/lambda ratio (K/L) in humoral immunity testing reports to improve the detection rate of M-proteinemia.

METHODS

156 M protein-positive and 5464 M protein-negative samples confirmed by serum immunofixation electrophoresis(sIFE) were accumulated from January 2021 to December 2023 in the First Affiliated Hospital of Soochow University and the contents of immunoglobulins (IgG, IgA, IgM, kappa and lambda) were tested by Beckman IMMAGE800. All the samples were divided into two groups by time: the modeling group and the validation group. The K/L values in the modeling group were analyzed by SPSS 27.0 to get the receiver operating characteristic curve (ROC). Furthermore, a more in-depth analysis was conducted to verify the reliability of the optimal cutoff values in the validation group. In addition, the levels of immunoglobulins of another group including 106 patients with definite diagnosis of monoclonal gammopathy ranging from January 2021 to June 2024 were traced back to improve the diagnostic efficiency.

RESULTS

The optimal cutoff values of K/L were 2.31 and 1.43 corresponding to K-type and L-type M-proteinemia respectively by ROC analysis. The sensitivity and specificity were validated as 76.14% and 77.42%. False positives were mainly found in samples with systemic sclerosis (36.84%), hypohepatia (28.71%) and sicca syndrome (27.27%). While false negatives were mainly found in IgA monoclonal gammopathy (38.39%) and IgM monoclonal gammopathy (28.57%). Combining with the detection rules of IgG, IgA and IgM, the sensitivities for the diagnosis of immunoglobulin light chain amyloidosis(AL) and monoclonal gammopathy of undetermined significance(MGUS) can be increased to 83.33% and 85%.

CONCLUSIONS

K/L > 2.31 and K/L < 1.43 can be used as warning values for M-proteinemia. In addition, the content of the heavy chain in IgA- or IgM-type M-proteinemia may be considered to improve the detection rate.

摘要

背景

引入血清总κ/λ比值（K/L）在体液免疫检测报告中，以提高 M 蛋白血症的检出率。

方法

2021 年 1 月至 2023 年 12 月，苏州大学附属第一医院共积累了 156 例经血清免疫固定电泳（sIFE）证实的 M 蛋白阳性和 5464 例 M 蛋白阴性样本，采用 Beckman IMMAGE800 检测免疫球蛋白（IgG、IgA、IgM、κ和 λ）含量。所有样本按时间分为两组：建模组和验证组。采用 SPSS 27.0 对建模组的 K/L 值进行分析，得到受试者工作特征曲线（ROC）。此外，还对验证组的最佳截断值进行了更深入的分析，以验证其可靠性。此外，还对 2021 年 1 月至 2024 年 6 月期间确诊为单克隆丙种球蛋白病的 106 例患者的另一组免疫球蛋白水平进行了追溯，以提高诊断效率。

结果

通过 ROC 分析，K/L 的最佳截断值分别为 2.31 和 1.43，对应于 K 型和 L 型 M 蛋白血症。灵敏度和特异性分别为 76.14%和 77.42%。假阳性主要见于系统性硬化症（36.84%）、低肝血症（28.71%）和干燥综合征（27.27%）患者的样本中。而假阴性主要见于 IgA 单克隆丙种球蛋白病（38.39%）和 IgM 单克隆丙种球蛋白病（28.57%）患者的样本中。结合 IgG、IgA 和 IgM 的检测规则，免疫球蛋白轻链淀粉样变性（AL）和意义未明的单克隆丙种球蛋白病（MGUS）的诊断灵敏度可提高至 83.33%和 85%。