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Clinical Chemistry and Laboratory Medicine (CCLM)

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Immunochemical quantification of free immunoglobulin light chains from an analytical perspective

Takanari Nakano
  • Department of Biochemistry, Saitama Medical School, Saitama, Japan
/ Shuichi Miyazaki
  • Immunology Laboratory, Diagnostics Department, YAMASA Corporation, Chiba, Japan
/ Hidenori Takahashi
  • Department of Clinical Laboratory, Asahi General Hospital, Asahi, Chiba, Japan
/ Akira Matsumori
  • Department of Cardiovascular Medicine, Kyoto University Graduate School of Medicine, Kyoto, Japan
/ Taro Maruyama
  • Department of Medicine, Saitama Social Insurance Hospital, Saitama, Japan
/ Tsugikazu Komoda
  • Department of Biochemistry, Saitama Medical School, Saitama, Japan
/ Atsuo Nagata
  • Immunology Laboratory, Diagnostics Department, YAMASA Corporation, Chiba, Japan


Immunoglobulin light chains are components of antibodies, but some exist in a free form in serum and urine as a result of their excess production over heavy chains. Free light chain (FLC) levels are of the order of milligram per liter in normal serum and urine, but marked increases have been observed in various disease conditions. It has now been established that the measurement of FLC levels contributes to diagnosis and clinical management in monoclonal gammopathies. Recent developments in FLC assays have been adapted to several automated platforms and they have now become available in laboratories. There have, however, been some concerns regarding the analytical aspects. The current assay specificity appears to be insufficient to prevent the influence of intact light chains of several orders of magnitude greater than FLCs in serum. Moreover, the heterogeneous nature of light chains makes accurate quantification unreliable. FLC assays have never been standardized because of the lack of an international reference calibrator. In this review, we summarize the reports on FLC measurements and examine the specificity of anti-FLC antibodies and the reliability of FLC assays. We also discuss difficulties in the standardization and setting of normal reference intervals for FLC assays.

Keywords: antibody; Bence Jones protein; free immunoglobulin light chain; immunoassay; standardization

Disclosure of potential conflicts of interest: S. Miyazaki and A. Nagata are employees of YAMASA Corporation, which provides materials for FLC ELISAs, and they will be involved in marketing these products. T. Nakano and A. Nagata have developed FLC ELISAs at YAMASA. Corresponding author: Takanari Nakano, PhD, Department of Biochemistry, Saitama Medical School, 38 Morohongo, Moroyama, Iruma-gun, Saitama 350-0495, Japan Phone/Fax: +81-492-76-1155,

Received: January 14, 2006

Accepted: March 15, 2006

Published in Print: 2006-05-01

Citation Information: Clinical Chemical Laboratory Medicine. Volume 44, Issue 5, Pages 522–532, ISSN (Online) 1437-4331, ISSN (Print) 1434-6621, DOI: https://doi.org/10.1515/CCLM.2006.118, May 2006

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