Diagnostic performance of quantitative κ and λ free light chain assays in clinical practice
Diagnostic performance of quantitative κ and λ free light chain assays in clinical practice
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DOI：
10.1373/clinchem.2004.046870
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发表时间：
2005-05-01
影响因子：
9.3
通讯作者：
Kyle, RA
中科院分区：
文献类型：
--
作者：
Katzmann, JA;Abraham, RS;Kyle, RA
背景：游离轻链（FLCs）定量检测是最近引入的一种商业检测方法，据报道对检测FLC疾病如原发性系统性淀粉样变性（AL）、轻链沉积病（LCDD）、非分泌性多发性骨髓瘤（NSMM）和轻链多发性骨髓瘤具有敏感性和特异性。我们在临床实践中评估了它的诊断性能。方法：从实验室信息系统中提取2003年所有FLC临床检测结果。诊断来自蛋白异常血症数据库和患者病史。结果：2003年，我们收到1020名梅奥诊所患者的FLC检测样本。这些患者中的大多数（88%）患有骨髓源性单克隆浆细胞疾病（PCDs）。121名患者没有。单克隆伽玛病的FLC kappa/lambda比值均在我们实验室获得的参考人群的值范围内。单克隆病变患者包括多发性骨髓瘤（330例）、AL（269例）、意义不明的单克隆病变（114例）、阴积性多发性骨髓瘤（72例）、浆细胞瘤（22例）、NSMM（20例）、巨球蛋白血症（9例）、LCDD（7例）和其他多种PCDs。在110例未接受过治疗且在诊断120天内进行FLC检测的AL患者中，FLC kappa/lambda比率为91%，而血清免疫固定电泳（IFE）为69%，尿液IFE为83%。血清IFE和血清FLC联合检测在99%（110例中的109例）al患者中检测出异常结果。结论：FLC检测在临床实验室数据分析中的表现与已发表的回顾性验证研究结果一致。(c) 2005年美国临床化学协会。
Background: The quantitative assay for free light chains (FLCs) is a recently introduced commercial test reported to be sensitive and specific for detecting FLC diseases such as primary systemic amyloidosis (AL), light chain deposition disease (LCDD), nonsecretory multiple myeloma (NSMM), and light chain multiple myeloma. We evaluated its diagnostic performance in clinical practice.Methods: All FLC clinical test results generated in 2003 were abstracted from the Laboratory Information System. Diagnoses were obtained from the Dysproteinemia database and the patient medical history.Results: In 2003, we received samples for FLC assays from 1020 Mayo Clinic patients. The majority of these patients (88%) had bone marrow-derived monoclonal plasma cell disorders (PCDs). The 121 patients who did not have. monoclonal gammopathy all had FLC kappa/lambda ratios within the range of values obtained for a reference population in our laboratory. Among the patients with monoclonal gammopathies were patients with multiple myeloma (330), AL (269), monoclonal gammopathy of undetermined significance (114), smoldering multiple myeloma (72), plasmacytoma (22), NSMM (20), macroglobulinemia (9), LCDD (7), and a variety of other PCDs. Among the 110 AL patients who had not been previously treated and who had a FLC assay performed within 120 days of diagnosis, the FLC kappa/lambda ratio was positive in 91% compared with 69% for serum immunofixation electrophoresis (IFE) and 83% for urine IFE. The combination of serum IFE and serum FLC assay detected an abnormal result in 99% (109 of 110) of patients with AL.Conclusion: The performance of the FLC assay in this analysis of clinical laboratory data is consistent with results from published retrospective validation studies. (c) 2005 American Association for Clinical Chemistry.