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Clinical Chemistry and Laboratory Medicine (CCLM)

Published in Association with the European Federation of Clinical Chemistry and Laboratory Medicine (EFLM)

Editor-in-Chief: Plebani, Mario

Ed. by Gillery, Philippe / Lackner, Karl J. / Lippi, Giuseppe / Melichar, Bohuslav / Payne, Deborah A. / Schlattmann, Peter / Tate, Jillian R.

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1437-4331
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Volume 49, Issue 8 (Aug 2011)

Issues

N Latex FLC – new monoclonal high-performance assays for the determination of free light chain kappa and lambda

Henk te Velthuis
  • Sanquin Reagents, Sanquin Blood Supply, Amsterdam, The Netherlands
  • Department of Immunopathology, Sanquin Research and Landsteiner Laboratory, Academic Medical Center, Amsterdam, The Netherlands
  • Email:
/ Ingrid Knop
  • Sanquin Reagents, Sanquin Blood Supply, Amsterdam, The Netherlands
/ Peter Stam
  • Sanquin Reagents, Sanquin Blood Supply, Amsterdam, The Netherlands
/ Monic van den Broek
  • Sanquin Reagents, Sanquin Blood Supply, Amsterdam, The Netherlands
/ Hannie Klaasse Bos
  • Department of Immunopathology, Sanquin Research and Landsteiner Laboratory, Academic Medical Center, Amsterdam, The Netherlands
/ Suzanne Hol
  • Sanquin Reagents, Sanquin Blood Supply, Amsterdam, The Netherlands
/ Elisa Teunissen
  • Sanquin Reagents, Sanquin Blood Supply, Amsterdam, The Netherlands
/ Karin Schulte Fischedick
  • Sanquin Reagents, Sanquin Blood Supply, Amsterdam, The Netherlands
/ Harald Althaus
  • Department of Plasma Proteins, Siemens Healthcare Diagnostics, Marburg, Germany
/ Brigitta Schmidt
  • Department of Plasma Proteins, Siemens Healthcare Diagnostics, Marburg, Germany
/ Carola Wagner
  • Department of Plasma Proteins, Siemens Healthcare Diagnostics, Marburg, Germany
/ Roel Melsert
  • Sanquin Reagents, Sanquin Blood Supply, Amsterdam, The Netherlands
Published Online: 2011-06-11 | DOI: https://doi.org/10.1515/CCLM.2011.624

Abstract

Background: High serum concentrations of monoclonal free light chain (FLC) kappa or lambda are markers of plasma cell dyscrasia.

Methods: We developed new, latex-enhanced, specific nephelometric assays based on monoclonal antibodies for the determination of FLC kappa and lambda in serum, EDTA plasma and Li-heparin plasma for use on the Siemens BN™ systems.

Results: Reference ranges were determined from 369 samples: FLC kappa 6.7–22.4 mg/L, FLC lambda 8.3–27.0 mg/L and kappa/lambda ratio 0.31–1.56. Protection from falsely low results due to antigen excess is obtained with a built-in pre-reaction in the assay protocols. Lot-to-lot consistency between three different lots of reagent, calibrators and supplementary reagent lots showed normalized differences <7.5%. The reproducibility of serum samples varied between 4% and 7%. The method comparison with Freelite™ assays showed normalized differences of 19.7%, 32.7% and 21.7%, respectively, for FLC kappa, lambda and ratio, correlations of 0.94, 0.77 and 0.73, and concordance rates of 99.2%, 94.2% and 95%.

Conclusions: N Latex FLC demonstrates high precision, good lot-to-lot consistency and freedom from a high-dose hook effect. The method comparison between Freelite™ and the N Latex FLC assays showed good clinical concordance. Further studies need to reveal the clinical value of the new FLC assays.

About the article

Corresponding author: Dr. Henk te Velthuis, Department of R&D, Sanquin Reagents, Plesmanlaan 125, 1066CX Amsterdam, The Netherlands Phone: +31 20 512 3665, Fax: +31 20 512 3170


Received: 2011-03-03

Accepted: 2011-03-22

Published Online: 2011-06-11

Published in Print: 2011-08-01


Citation Information: Clinical Chemistry and Laboratory Medicine, ISSN (Online) 1437-4331, ISSN (Print) 1434-6621, DOI: https://doi.org/10.1515/CCLM.2011.624. Export Citation

©2011 by Walter de Gruyter Berlin Boston. This content is open access.

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