Abstract：
Monoclonal gammopathy (MG) is a spectrum of diseases ranging from the benign asymptomatic monoclonal gammopathy of undetermined significance to the malignant multiple myeloma. Clinical guidelines and laboratory recommendations have been developed to inform best practices in the diagnosis, monitoring, and management of MG. In this review, the pathophysiology, relevant laboratory testing recommended in clinical practice guidelines and laboratory recommendations related to MG testing and reporting are examined. The clinical guidelines recommend serum protein electrophoresis, serum immunofixation and serum free light chain measurement as initial screening. The laboratory recommendations omit serum immunofixation as it offers limited additional diagnostic value. The laboratory recommendations offer guidance on reporting findings beyond monoclonal protein, which was not required by the clinical guidelines. The clinical guidelines suggested monitoring total IgA concentration by turbidimetry or nephelometry method if the monoclonal protein migrates in the non-gamma region, whereas the laboratory recommendations make allowance for involved IgM and IgG. Additionally, several external quality assurance programs for MG protein electrophoresis and free light chain testing are also appraised. The external quality assurance programs show varied assessment criteria for protein electrophoresis reporting and unit of measurement. There is also significant disparity in reported monoclonal protein concentrations with wide inter-method analytical variation noted for both monoclonal protein quantification and serum free light chain measurement, however this variation appears smaller when the same method was used. Greater harmonization among laboratory recommendations and reporting format may improve clinical interpretation of MG testing.
摘要：
单克隆丙种球蛋白病（MG）是一系列疾病，从意义不明的良性无症状单克隆丙种球蛋白病到恶性多发性骨髓瘤。已经制定了临床指南和实验室建议，以告知诊断的最佳实践。监测,和管理MG。在这次审查中,病理生理学，检查临床实践指南中推荐的相关实验室检测以及与MG检测和报告相关的实验室建议.临床指南推荐血清蛋白电泳，血清免疫固定和血清游离轻链测定作为初步筛选。实验室建议省略了血清免疫固定，因为它提供的额外诊断价值有限。实验室建议为报告单克隆蛋白质以外的发现提供了指导，这不是临床指南所要求的。临床指南建议，如果单克隆蛋白在非γ区迁移，则通过比浊法或比浊法监测总IgA浓度。而实验室建议考虑了涉及的IgM和IgG。此外,还评估了用于MG蛋白电泳和游离轻链测试的几个外部质量保证程序。外部质量保证计划显示了蛋白质电泳报告和测量单位的各种评估标准。对于单克隆蛋白定量和血清游离轻链测量，已报道的单克隆蛋白浓度也存在显着差异，方法间分析差异很大。然而，当使用相同的方法时，这种变化看起来更小。实验室建议和报告格式之间的更大协调可能会改善MG测试的临床解释。
