Bergón Enrique, Miravalles Elena, Bergón Elena, Miranda Isabel, Bergón Marta
Department of Clinical Pathology, Hospital Universitario de Getafe, Madrid, Spain.
Clin Chem Lab Med. 2005;43(1):32-7. doi: 10.1515/CCLM.2005.004.
The predictive power of serum kappa/lambda ratios on initial presentation of immunoglobulin G (IgG) or IgA monoclonal component was studied to differentiate between monoclonal gammopathy of undetermined significance (MGUS) and multiple myeloma (MM) patients. The retrospective study involved 145 patients clinically diagnosed with monoclonal gammopathy of undetermined significance or multiple myeloma, who had serum M-protein IgG <35 g/L or IgA <20 g/L at M-protein detection. Serum light chains kappa and lambda were measured by fixed-time nephelometry. Test performance indices, predictive values and likelihood ratios were calculated according to the Weissler recommendation. MM patients were considered as diseased and MGUS patients as non-diseased in order to estimate the performance characteristics of serum kappa/lambda ratios. There was a statistically significant difference in kappa/lambda ratios distribution between both groups of patients, in both M-protein kappa-type (Mann-Whitney U=168, p<0.001) and in M-protein lambda-type (Mann-Whitney U=143, p<0.001). Negative likelihood ratios at threshold levels of 0.6 and 4.2 were 2.17- and 3.32-fold greater, respectively, than positive likelihood ratios, so that the predictive power of a serum kappa/lambda ratio within these limits is better in ruling out (negative predictive power) than ruling in disease (positive predictive power). The post-test characteristics of a serum kappa/lambda ratio interval between 0.6 and 4.2 in discriminating MGUS from MM in our geographic population were: sensitivity 0.96 (0.93-0.99 95% CI); specificity 0.70 (0.63-0.77); positive predictive value 0.68 (0.64-0.73); negative predictive value 0.96 (0.94-0.99); likelihood ratios (+)LR 3.23 (2.68-4.04); and (-)LR 17.16 (11.00-63.00). Thus, serum M-protein with a kappa/lambda ratio between 0.6 and 4.2 increases the posterior probability of MGUS from 0.60 to 0.96 in asymptomatic patients, for whom only monitoring may be suggested when the serum kappa/lambda ratio is within these limits.
研究了血清κ/λ比值对免疫球蛋白G(IgG)或IgA单克隆成分初始表现的预测能力,以区分意义未明的单克隆丙种球蛋白病(MGUS)和多发性骨髓瘤(MM)患者。这项回顾性研究纳入了145例临床诊断为意义未明的单克隆丙种球蛋白病或多发性骨髓瘤的患者,这些患者在检测M蛋白时血清M蛋白IgG<35 g/L或IgA<20 g/L。采用定时散射比浊法检测血清轻链κ和λ。根据Weissler建议计算检验性能指标、预测值和似然比。为了评估血清κ/λ比值的性能特征,将MM患者视为患病,MGUS患者视为未患病。两组患者的κ/λ比值分布在M蛋白κ型(Mann-Whitney U=168,p<0.001)和M蛋白λ型(Mann-Whitney U=143,p<0.001)中均存在统计学显著差异。在阈值水平为0.6和4.2时,阴性似然比分别比阳性似然比大2.17倍和3.32倍,因此,在此范围内的血清κ/λ比值在排除疾病(阴性预测能力)方面比诊断疾病(阳性预测能力)的预测能力更好。在我们的地理人群中,血清κ/λ比值在0.至4.2之间区分MGUS和MM的检验后特征为:敏感性0.96(0.93-0.99 95%CI);特异性0.70(0.63-0.77);阳性预测值0.68(0.64-0.73);阴性预测值0.96(0.94-0.99);似然比(+)LR 3.23(2.68-4.04);以及(-)LR 17.16(11.00-63.00)。因此,对于无症状患者,血清M蛋白κ/λ比值在0.6至4.2之间可将MGUS的后验概率从0.60提高到0.96,当血清κ/λ比值在此范围内时,可能仅建议对其进行监测。