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Clinical Chemistry 48: 1437-1444, 2002;
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(Clinical Chemistry. 2002;48:1437-1444.)
© 2002 American Association for Clinical Chemistry, Inc.

Serum Reference Intervals and Diagnostic Ranges for Free {kappa} and Free {lambda} Immunoglobulin Light Chains: Relative Sensitivity for Detection of Monoclonal Light Chains

Jerry A. Katzmann1a, Raynell J. Clark1, Roshini S. Abraham1, Sandra Bryant1, James F. Lymp1, Arthur R. Bradwell2 and Robert A. Kyle1

1 Mayo Clinic, 200 First St. SW, Rochester, MN 55905.

2 The Binding Site Ltd and The Medical School, University of Birmingham, Birmingham B15 2TT, England.

aAddress correspondence to this author at: Mayo Clinic, Hilton Bldg., Room 920, 200 First St. SW, Rochester, MN 55905. Fax 507-266-4088; e-mail katzmann{at}mayo.edu.

Background: The detection of monoclonal free light chains (FLCs) is an important diagnostic aid for a variety of monoclonal gammopathies and is especially important in light-chain diseases, such as light-chain myeloma, primary systemic amyloidosis, and light-chain-deposition disease. These diseases are more prevalent in the elderly, and assays to detect and quantify abnormal amounts of FLCs require reference intervals that include elderly donors.

Methods: We used an automated immunoassay for FLCs and sera from a population 21–90 years of age. We used the calculated reference and diagnostic intervals to compare FLC results with those obtained by immunofixation (IFE) to detect low concentrations of monoclonal {kappa} and {lambda} FLCs in the sera of patients with monoclonal gammopathies.

Results: Serum {kappa} and {lambda} FLCs increased with population age, with an apparent change for those >80 years. This trend was lost when the FLC concentration was normalized to cystatin C concentration. The ratio of {kappa} FLC to {lambda} FLC (FLC K/L) did not exhibit an age-dependent trend. The diagnostic interval for FLC K/L was 0.26–1.65. The 95% reference interval for {kappa} FLC was 3.3–19.4 mg/L, and that for {lambda} FLC was 5.7–26.3 mg/L. Detection and quantification of monoclonal FLCs by nephelometry were more sensitive than IFE in serum samples from patients with primary systemic amyloidosis and light-chain-deposition disease.

Conclusions: Reference and diagnostic intervals for serum FLCs have been developed for use with a new, automated immunoassay that makes the detection and quantification of monoclonal FLCs easier and more sensitive than with current methods. The serum FLC assay complements IFE and allows quantification of FLCs in light-chain-disease patients who have no detectable serum or urine M-spike.




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