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Assessment of serum free light chain measurements in a large Chinese chronic kidney disease cohort: a multicenter real-world study

  • Xia Luo , Xiaomeng Zhang , Xu Yuan , Pan Zhao , Wenqian Zhang , Lingyan Deng EMAIL logo und Liming Cheng EMAIL logo
Veröffentlicht/Copyright: 14. April 2025
Clinical Chemistry and Laboratory Medicine (CCLM)
Aus der Zeitschrift Clinical Chemistry and Laboratory Medicine (CCLM) Band 63 Heft 9

Abstract

Objectives

Diagnosing monoclonal gammopathy in chronic kidney disease (CKD) patients is challenging due to the complex interpretation of serum free light chain (FLC) levels. This study aimed to assess the FLC levels in a large cohort of Chinese CKD patients.

Methods

We enrolled 5,287 patients with all-cause nondialysis CKD from three medical centers between February 2018 and April 2023. Central 95 % reference ranges were established using data from one center and validated in an independent subpopulation from the other two centers. The crude prevalence of light chain monoclonal gammopathy of undetermined significance (LC-MGUS) was assessed against established norms for the entire cohort and subgroups based on estimated glomerular filtration rate (eGFR).

Results

A notable proportion of patients exceeded the standard reference limits for kappa (89.0 %), lambda (72.1 %), and FLC ratio (10.5 %), whereas non-eGFR-based renal reference interval identified only 0.3 % with abnormal FLC ratios. The iStopMM reference ranges showed higher out-of-range rates for absolute FLC levels in patients with preserved kidney function and lower rates in those with impaired kidney function, while the FLC ratio references remained robust across all groups. The crude prevalence of LC-MGUS was 10.4 % using standard ranges, predominantly kappa LC-MGUS (99.8 %). This prevalence decreased to 0.3 % with non-eGFR-based renal reference interval and 0.5 % with the iStopMM ranges. Using the newly established reference ranges, the crude prevalence was found to be 0.9 %.

Conclusions

Our findings suggest that current FLC reference ranges are inadequate for the Chinese population, underscoring the need for eGFR-based reference ranges tailored to this demographic.

Keywords: chronic kidney disease; free light chain; light chain monoclonal gammopathy of undetermined significance; monoclonal gammopathy; reference range
Corresponding authors: Prof. Lingyan Deng and Prof. Liming Cheng, Department of Laboratory Medicine, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, 1095 Jiefang Avenue, Wuhan, 430030, China, E-mail: (L. Deng), (L. Cheng)

Acknowledgments

We express our gratitude to the Department of Laboratory Medicine at Tongji Hospital for supplying the instruments and reagents needed for sample testing.

  1. Research ethics: This research protocol was reviewed and approved by the Ethics Committee at Tongji Hospital, affiliated with Tongji Medical College, Huazhong University of Science and Technology (Approval Number: TJ-IRB202410040). This research complies with the ethical principles outlined in the Declaration of Helsinki.

  2. Informed consent: Not applicable.

  3. Author contributions: LmC and LyD conceived and designed the study. XL and XmZ contributed to the statistical analysis and were responsible for writing the original draft, as well as reviewing and editing the manuscript. XY, PZ and WqZ conducted specimen measurements and reviewed the electronic medical records. LmC and LyD had primary responsibility for the final content of the manuscript. All authors participated in critical revisions and approved the final version.

  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 data that support the findings of this study are not publicly available due to their containing information that could compromise the privacy of research participants but are available from the corresponding author [LmC].

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Supplementary Material

This article contains supplementary material (https://doi.org/10.1515/cclm-2024-1226).

Received: 2024-10-21
Accepted: 2025-04-02
Published Online: 2025-04-14
Published in Print: 2025-08-26

© 2025 Walter de Gruyter GmbH, Berlin/Boston

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https://doi.org/10.1515/cclm-2024-1226
Schlagwörter für diesen Artikel
chronic kidney disease; free light chain; light chain monoclonal gammopathy of undetermined significance; monoclonal gammopathy; reference range

Artikel in diesem Heft

  1. Frontmatter
  2. Editorial
  3. Macroprolactinaemia – some progress but still an ongoing problem
  4. Review
  5. Understanding the circulating forms of cardiac troponin: insights for clinical practice
  6. Opinion Papers
  7. New insights in preanalytical quality
  8. IFCC recommendations for internal quality control practice: a missed opportunity
  9. Genetics and Molecular Diagnostics
  10. Evaluation of error detection and treatment recommendations in nucleic acid test reports using ChatGPT models
  11. General Clinical Chemistry and Laboratory Medicine
  12. Pre-analytical phase errors constitute the vast majority of errors in clinical laboratory testing
  13. Improving the efficiency of quality control in clinical laboratory with an integrated PBRTQC system based on patient risk
  14. IgA-type macroprolactin among 130 patients with macroprolactinemia
  15. Prevalence and re-evaluation of macroprolactinemia in hyperprolactinemic patients: a retrospective study in the Turkish population
  16. Defining dried blood spot diameter: implications for measurement and specimen rejection rates
  17. Screening primary aldosteronism by plasma aldosterone-to-angiotensin II ratio
  18. Assessment of serum free light chain measurements in a large Chinese chronic kidney disease cohort: a multicenter real-world study
  19. Beyond the Hydrashift assay: the utility of isoelectric focusing for therapeutic antibody and paraprotein detection
  20. Direct screening and quantification of monoclonal immunoglobulins in serum using MALDI-TOF mass spectrometry without antibody enrichment
  21. Effect of long-term frozen storage on stability of kappa free light chain index
  22. Impact of renal function impairment on kappa free light chain index
  23. Standardization challenges in antipsychotic drug monitoring: insights from a national survey in Chinese TDM practices
  24. Potential coeliac disease in children: a single-center experience
  25. Vitamin D metabolome in preterm infants: insights into postnatal metabolism
  26. Candidate Reference Measurement Procedures and Materials
  27. Development of commutable candidate certified reference materials from protein solutions: concept and application to human insulin
  28. Reference Values and Biological Variations
  29. Biological variation of serum cholinesterase activity in healthy subjects
  30. Hematology and Coagulation
  31. Diagnostic performance of morphological analysis and red blood cell parameter-based algorithms in the routine laboratory screening of heterozygous haemoglobinopathies
  32. Cancer Diagnostics
  33. Promising protein biomarkers for early gastric cancer: clinical performance of combined detection
  34. Infectious Diseases
  35. The accuracy of presepsin in diagnosing neonatal late-onset sepsis in critically ill neonates: a prospective study
  36. Corrigendum
  37. The Unholy Grail of cancer screening: or is it just about the Benjamins?
  38. Letters to the Editor
  39. Analytical validation of hemolysis detection on GEM Premier 7000
  40. Reconciling reference ranges and clinical decision limits: the case of thyroid stimulating hormone
  41. Contradictory definitions give rise to demands for a right to unambiguous definitions
  42. Biomarkers to measure the need and the effectiveness of therapeutic supplementation: a critical issue
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