The free light chain (FLC) ratio is a critical part of risk stratification for monoclonal gammopathy of undetermined significance (MGUS). Recently, revised FLC reference intervals developed using the iStopMM cohort, accounting for age and renal function, have reduced the rate of abnormal findings. Here, we examine the implications of the revision in an independent Danish MGUS cohort. Of 6993 MGUS individuals, 2641 had an abnormal FLC ratio by the original intervals, of whom 844 (32%) were reclassified as normal using the revised intervals. Reclassified individuals had no significantly increased risk of progression compared to those with a normal FLC ratio (hazard ratio (HR): 1.07, 95% confidence interval (CI) 0.74–1.57). Those with an abnormal FLC ratio by the revised reference intervals had an increased risk of progression (HR 2.23, 95% CI 1.79–2.78). Using the revised reference intervals, 490 individuals (16%) were reclassified to low-risk from a higher risk group. These individuals had a similar progression risk compared to others in the low-risk group. The findings validate the revised FLC reference intervals, enhancing prognostic accuracy and improving risk stratification to accurately identify MGUS individuals at risk of progression while reducing unnecessary classifications as high-risk.
游离轻链（FLC）比值是意义未明的单克隆丙种球蛋白病（MGUS）风险分层的关键部分。最近，利用iStopMM队列开发的修订版FLC参考区间，考虑了年龄和肾功能，降低了异常发现率。在此，我们在一个独立的丹麦MGUS队列中检验了此次修订的影响。在6993名MGUS个体中，根据原始区间，2641人FLC比值异常，其中844人（32%）使用修订区间后被重新分类为正常。与FLC比值正常者相比，重新分类的个体进展风险无显著增加（风险比（HR）：1.07，95%置信区间（CI）0.74–1.57）。根据修订参考区间FLC比值异常者进展风险增加（HR 2.23，95% CI 1.79–2.78）。使用修订参考区间，490名个体（16%）从高风险组重新分类为低风险组。这些个体与低风险组中的其他人具有相似的进展风险。这些发现验证了修订版FLC参考区间，提高了预后准确性并改善了风险分层，从而准确识别有进展风险的MGUS个体，同时减少不必要的分类为高风险。
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