Serum free light chain quantitative assays: Dilemma of a biomarker

Giovanni Cigliana, Francesca Gulli, Cecilia Napodano, Krizia Pocino, Elena De Santis, Luigi Colacicco, Iole Cordone, Laura Conti, Umberto Basile

Risultato della ricerca: Contributo in rivistaArticolo in rivista

9 Citazioni (Scopus)


Background: Serum free light chains detection assays are consistently meeting greater interest for the diagnosis and monitoring of monoclonal gammopathies and plasma cell dyscrasias. Nowadays, there are neither standardized methods nor reference material for the determination of free light chains; for this reason, it is important to compare two different assays used in clinical laboratory. Methods: We evaluated 300 serum samples from patients with B-cell disorders and compared the analytical performances of both assay. Each test was assayed on both testing platforms (Siemens Dade Behring BN II Nephelometer and SPAPLUS by The Binding Site). κ/λ ratios were determined and compared. Results were analyzed by Passing-Bablok and Bland-Altman plots to evaluate comparability of the two techniques and to determine bias. Results: The reproducibility of both assays is acceptable, reaching minimum and desirable analytical goals derived from biological variability. However, values are not interchangeable between systems. This study shows that the two systems do not allow results to be transferred from one method to the other even if they display good agreement. Conclusion: Our study highlights the importance of elaborating an international standard for free light chains quantification in order to offer homogeneous results as well as guarantee harmonization of values among laboratories. Moreover, the assays should be validated in specific patient groups to determine that they are clinically fit for purpose.
Lingua originaleEnglish
pagine (da-a)e22243-N/A
RivistaJournal of Clinical Laboratory Analysis
Stato di pubblicazionePubblicato - 2018


  • Aged
  • Biomarkers
  • Biomarkers, Tumor
  • Female
  • Humans
  • Immunoglobulin Light Chains
  • Linear Models
  • Male
  • Middle Aged
  • Multiple Myeloma
  • Reproducibility of Results
  • comparative study
  • free light chains
  • multiple myeloma


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