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单克隆丙种球蛋白病患者血清游离轻链免疫测定的分析性能和灵敏度评估。

Assessment of the analytical performance and the sensitivity of serum free light chains immunoassay in patients with monoclonal gammopathy.

作者信息

Wolff Fleur, Thiry Claire, Willems Dominique

机构信息

Laboratory of Clinical Chemistry, CHU Brugmann, Place Van Gehuchten 4, 1020 Brussels, Belgium.

出版信息

Clin Biochem. 2007 Mar;40(5-6):351-4. doi: 10.1016/j.clinbiochem.2006.11.011. Epub 2006 Dec 19.

Abstract

OBJECTIVES

A new immunoassay which quantifies Kappa, Lambda free light chains (FLC) and a ratio of Kappa to Lambda FLC has been reported to be sensitive for detecting a variety of FLC diseases. We assessed the analytical criteria and the diagnostic performance of this immunoassay in patients who present a monoclonal gammopathy.

DESIGN AND METHODS

Quantification of FLC, serum protein electrophoresis (SPE) and immunofixation (IFE) were performed on patients who present a monoclonal gammopathy of undetermined significance (MGUS), an intact immunoglobulin multiple myeloma (IIMM) or a light chain multiple myeloma (LCMM).

RESULTS

The monoclonal component was identified by IFE in the sera of all patients. Based on the diagnostic reference range, the ratio of Kappa to Lambda FLC was abnormal in 25% of the tested population, compared to 94% for SPE in MGUS patients. For IIMM and LCMM, the FLC ratio was abnormal in 70% and 100% of the population, compared to 85% and 40% for SPE, respectively.

CONCLUSION

SPE and IFE have a higher sensitivity for identifying MGUS and IIMM.

摘要

目的

据报道,一种新的免疫测定法可定量κ、λ游离轻链(FLC)以及κ与λ FLC的比值,对检测多种FLC疾病具有敏感性。我们评估了这种免疫测定法在出现单克隆丙种球蛋白病患者中的分析标准和诊断性能。

设计与方法

对出现意义未明的单克隆丙种球蛋白病(MGUS)、完整免疫球蛋白多发性骨髓瘤(IIMM)或轻链多发性骨髓瘤(LCMM)的患者进行FLC定量、血清蛋白电泳(SPE)和免疫固定电泳(IFE)检测。

结果

通过IFE在所有患者血清中鉴定出单克隆成分。基于诊断参考范围,κ与λ FLC的比值在25%的受测人群中异常,而在MGUS患者中SPE的异常率为94%。对于IIMM和LCMM,FLC比值在70%和100%的人群中异常,而SPE的异常率分别为85%和40%。

结论

SPE和IFE在识别MGUS和IIMM方面具有更高的敏感性。

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