Method comparison of four clinically available assays for serum free light chain analysis

Chérina K.A. Fleming 1 , Tim Swarttouw 1 , Corrie M. de Kat Angelino 2 , Joannes F.M. Jacobs 2  and Henk Russcher 1
  • 1 Department of Clinical Chemistry, Erasmus MC, University Medical Center Rotterdam, Rotterdam, The Netherlands
  • 2 Department of Laboratory Medicine, Radboud University Medical Center, Nijmegen, The Netherlands
Chérina K.A. Fleming
  • Department of Clinical Chemistry, Erasmus MC, University Medical Center Rotterdam, Rotterdam, The Netherlands
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, Tim Swarttouw
  • Department of Clinical Chemistry, Erasmus MC, University Medical Center Rotterdam, Rotterdam, The Netherlands
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, Corrie M. de Kat Angelino
  • Department of Laboratory Medicine, Radboud University Medical Center, Nijmegen, The Netherlands
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, Joannes F.M. Jacobs
  • Department of Laboratory Medicine, Radboud University Medical Center, Nijmegen, The Netherlands
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and Henk Russcher
  • Corresponding author
  • Department of Clinical Chemistry, Erasmus MC, University Medical Center Rotterdam, Rotterdam, The Netherlands
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Abstract

Background

Serum free light chain (sFLC) measurements are increasingly important in the context of screening for monoclonal gammopathies, prognostic stratification and monitoring of therapy responses. In this study we have performed a method comparison of four sFLC assays that are currently available for routine clinical use.

Methods

In a retrospective study, sFLC analyses were performed on a cohort that included 139 patients with various monoclonal gammopathies and 54 control sera without an M-protein. Method comparisons of the following four FLC assays were performed: Freelite (Binding Site), N-Latex FLC (Siemens), Seralite (Abingdon Health) and Sebia FLC (Sebia).

Results

Bland-Altman agreement analysis showed biases varying between −0.1 and 16.2 mg/L for κFLC, −6.0 and 6.8 mg/L for λFLC and −0.04 and 0.38 for the ratio of the involved to uninvolved FLC. Strong agreements were observed for FLC-concentrations below 100 mg/L. The clinical concordance of the κ/λFLC-ratio of the four methods varied between 86% and 92%. Significant quantitative differences were observed between the different methods, mainly in sera with high FLC concentrations. Most assays consistently overestimated FLC concentrations compared to SPE.

Conclusions

Good overall clinical concordances were observed between the four sFLC assays that were compared in this study. Although good agreements were observed between the FLC assays, significant absolute differences in FLC concentrations in individual patients can be seen, particularly at higher FLC concentrations. Because of inequivalent absolute sFLC values between the methods in individual patients, none of the four sFLC assays can be used interchangeably.

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Clinical Chemistry and Laboratory Medicine ( CCLM) publishes articles on novel teaching and training methods applicable to laboratory medicine. CCLM welcomes contributions on the progress in fundamental and applied research and cutting-edge clinical laboratory medicine. It is one of the leading journals in the field, with an impact factor of over three. CCLM is the official journal of nine national clinical societies and associated with EFLM.

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