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Immunochemical measurement of urinary free light chains and Bence Jones proteinuria

  • Laura Michetti ORCID logo EMAIL logo , Rudi Ravasio ORCID logo , Roberto Marozzi ORCID logo , Ester Antelmi ORCID logo , Arianna Ghirardi ORCID logo and Greta Bolzoni ORCID logo
Published/Copyright: May 30, 2025
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Clinical Chemistry and Laboratory Medicine (CCLM)
From the journal Clinical Chemistry and Laboratory Medicine (CCLM) Volume 63 Issue 10

Abstract

Objectives

To evaluate the characteristics of an immunochemical urinary free light chains (uFLC) test in screening and quantifying Bence Jones proteinuria (BJP) and its potential application in laboratory practice as an alternative to the gold standard method, urine immunofixation (UIFE) and densitometric quantification on 24 h urine sample.

Methods

A total of 300 subjects were divided into five groups: controls, patients with BJP Kappa and Lambda present in trace amounts not densitometrically quantifiable, and patients with BJP Kappa and Lambda present in densitometrically measurable quantities. The Wilcoxon-Mann-Whitney test was applied to compare uFLC in controls and BJP trace samples. The correlation between immunochemical and densitometric measurements was assessed using Spearman’s correlation coefficient, and agreement was evaluated with Bland-Altman plots. Samples were also stratified by estimated glomerular filtration rate (eGFR) and total urinary proteins (TUP).

Results

Despite significant differences between the median values of uFLC measures in controls and BJP in trace sample groups, using the uFLC upper reference ranges would have led to over 50 % false negative results. Although a strong correlation existed between the two methods, turbidimetry consistently overestimated BJP levels.

Conclusions

uFLC turbidimetric measurements cannot accurately differentiate negative samples from those containing trace BJP, lacking the sensitivity required for clinical use. UIFE has shown greater sensitivity compared to turbidimetry. In monitoring, the systematic overestimation in the quantification of BJP, aggravated in cases of reduced renal function or high TUP concentration, makes it challenging for clinicians to evaluate therapeutic efficacy since the decision thresholds outlined in clinical guidelines are based on densitometric measurements.

Keywords: monoclonal component densitometric quantification; monoclonal gammopathy; multiple myeloma; plasma cell dyscrasias; serum free light chains; urine immunofixation
Corresponding author: Laura Michetti, Department of Laboratory Medicine, Clinical Pathology Laboratory, ASST Papa Giovanni XXIII Hospital, Piazza OMS, 1, Bergamo, Italy, E-mail:

Acknowledgments

The authors are thankful to The Binding Site part of Thermo Fisher Scientific (Birmingham, UK) for its unconditional support in supplying Freelite kits.

  1. Research ethics: The study was approved by the local Ethical Committee of ASST Papa Giovanni XXIII Hospital of Bergamo (Reg. 165/20 approval date 14/01/2021) and was conducted according to the Declaration of Helsinki. Residual patient samples were obtained in a fully anonymized fashion and retrospective analysis was performed on anonymous data.

  2. Informed consent: Not applicable.

  3. Author contributions: All authors have accepted responsibility for the entire content of this manuscript and approved its submission.

  4. Use of Large Language Models, AI and Machine Learning Tools: None declared.

  5. Conflict of interest: The authors state no conflict of interest.

  6. Research funding: None declared.

  7. Data availability: The raw data are available from the corresponding author on reasonable request.

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Supplementary Material

This article contains supplementary material (https://doi.org/10.1515/cclm-2025-0265).

Received: 2025-03-06
Accepted: 2025-05-12
Published Online: 2025-05-30
Published in Print: 2025-09-25

© 2025 Walter de Gruyter GmbH, Berlin/Boston

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https://doi.org/10.1515/cclm-2025-0265
Keywords for this article
monoclonal component densitometric quantification; monoclonal gammopathy; multiple myeloma; plasma cell dyscrasias; serum free light chains; urine immunofixation

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  2. Editorial
  3. Quality indicators: an evolving target for laboratory medicine
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