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Clin Chem Lab Med. 2011 Aug;49(8):1323-32. doi: 10.1515/CCLM.2011.624. Epub 2011 Jun 10.

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

Author information

  • 1Sanquin Reagents, Sanquin Blood Supply, Amsterdam, The Netherlands. h.tevelthuis@sanquin.nl

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.

PMID:
21663464
[PubMed - indexed for MEDLINE]
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