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Received on December 15, 2004
Accepted on February 23, 2005
Hematology |
and 
Free Light Chain Assays in Clinical Practice
1 Division of Clinical Biochemistry and Immunology, Department of Laboratory Medicine and Pathology, and Division of Hematology, Department of Internal Medicine, Mayo Clinic College of Medicine, Rochester, MN
* To whom correspondence should be addressed. E-mail: katzmann{at}mayo.edu.
Background: The quantitative assay for free light chains (FLCs) is a recently introduced commercial test reported to be sensitive and specific for detecting FLC diseases such as primary systemic amyloidosis (AL), light chain deposition disease (LCDD), nonsecretory multiple myeloma (NSMM), and light chain multiple myeloma. We evaluated its diagnostic performance in clinical practice.
Methods: All FLC clinical test results generated in 2003 were abstracted from the Laboratory Information System. Diagnoses were obtained from the Dysproteinemia database and the patient medical history.
Results: In 2003, we received samples for FLC assays from 1020 Mayo Clinic patients. The majority of these patients (88%) had bone marrow-derived monoclonal plasma cell disorders (PCDs). The 121 patients who did not have monoclonal gammopathy all had FLC 
/
ratios within the range of values obtained for a reference population in our laboratory. Among the patients with monoclonal gammopathies were patients with multiple myeloma (330), AL (269), monoclonal gammopathy of undetermined significance (114), smoldering multiple myeloma (72), plasmacytoma (22), NSMM (20), macroglobulinemia (9), LCDD (7), and a variety of other PCDs. Among the 110 AL patients who had not been previously treated and who had a FLC assay performed within 120 days of diagnosis, the FLC / ratio was positive in 91% compared with 69% for serum immunofixation electrophoresis (IFE) and 83% for urine IFE. The combination of serum IFE and serum FLC assay detected an abnormal result in 99% (109 of 110) of patients with AL.
Conclusion: The performance of the FLC assay in this analysis of clinical laboratory data is consistent with results from published retrospective validation studies.
The following articles in journals at HighWire Press have cited this article:
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  R. B Fulton and S. L Fernando Serum free light chain assay reduces the need for serum and urine immunofixation electrophoresis in the evaluation of monoclonal gammopathy Ann Clin Biochem, September 1, 2009; 46(5): 407 - 412. [Abstract] [Full Text] [PDF]
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 S. Singhal, E. Vickrey, J. Krishnamurthy, V. Singh, S. Allen, and J. Mehta The relationship between the serum free light chain assay and serum immunofixation electrophoresis, and the definition of concordant and discordant free light chain ratios Blood, July 2, 2009; 114(1): 38 - 39. [Abstract] [Full Text] [PDF]
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G. Palladini, P. Russo, T. Bosoni, L. Verga, G. Sarais, F. Lavatelli, M. Nuvolone, L. Obici, S. Casarini, S. Donadei, et al. Identification of Amyloidogenic Light Chains Requires the Combination of Serum-Free Light Chain Assay with Immunofixation of Serum and Urine Clin. Chem., March 1, 2009; 55(3): 499 - 504. [Abstract] [Full Text] [PDF]
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A. P. Piehler, N. Gulbrandsen, P. Kierulf, and P. Urdal Quantitation of Serum Free Light Chains in Combination with Protein Electrophoresis and Clinical Information for Diagnosing Multiple Myeloma in a General Hospital Population Clin. Chem., November 1, 2008; 54(11): 1823 - 1830. [Abstract] [Full Text] [PDF]
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A. Dispenzieri, L. Zhang, J. A. Katzmann, M. Snyder, E. Blood, R. DeGoey, K. Henderson, R. A. Kyle, M. M. Oken, A. R. Bradwell, et al. Appraisal of immunoglobulin free light chain as a marker of response Blood, May 15, 2008; 111(10): 4908 - 4915. [Abstract] [Full Text] [PDF]
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 T. Bochtler, U. Hegenbart, C. Heiss, A. Benner, F. Cremer, M. Volkmann, J. Ludwig, J. B. Perz, A. D. Ho, H. Goldschmidt, et al. Evaluation of the serum-free light chain test in untreated patients with AL amyloidosis Haematologica, March 1, 2008; 93(3): 459 - 462. [Abstract] [Full Text] [PDF]
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M. A. Gertz, M. Q. Lacy, A. Dispenzieri, S. R. Hayman, S. K. Kumar, N. Leung, and D. A. Gastineau Effect of hematologic response on outcome of patients undergoing transplantation for primary amyloidosis: importance of achieving a complete response Haematologica, October 1, 2007; 92(10): 1415 - 1418. [Abstract] [Full Text] [PDF]
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S. Singhal, R. Stein, E. Vickrey, and J. Mehta The serum-free light chain assay cannot replace 24-hour urine protein estimation in patients with plasma cell dyscrasias Blood, April 15, 2007; 109(8): 3611 - 3612. [Full Text] [PDF]
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E. S.K. Ma and E. T.K. Lee A Case of IgM Paraproteinemia in Which Serum Free Light Chain Values Were Within Reference Intervals Clin. Chem., February 1, 2007; 53(2): 362 - 363. [Full Text] [PDF]
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 J. A. Katzmann, A. Dispenzieri, R. A. Kyle, M. R. Snyder, M. F. Plevak, D. R. Larson, R. S. Abraham, J. A. Lust, L. J. Melton III, and S. V. Rajkumar Elimination of the Need for Urine Studies in the Screening Algorithm for Monoclonal Gammopathies by Using Serum Immunofixation and Free Light Chain Assays Mayo Clin. Proc., December 1, 2006; 81(12): 1575 - 1578. [Abstract] [Full Text] [PDF]
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V. Sanchorawala Light-Chain (AL) Amyloidosis: Diagnosis and Treatment Clin. J. Am. Soc. Nephrol., November 1, 2006; 1(6): 1331 - 1341. [Abstract] [Full Text] [PDF]
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G. Merlini and M. J. Stone Dangerous small B-cell clones Blood, October 15, 2006; 108(8): 2520 - 2530. [Abstract] [Full Text] [PDF]
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N. C. Munshi Determining the undetermined Blood, August 1, 2005; 106(3): 767 - 768. [Full Text] [PDF]
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A. R. Bradwell Serum Free Light Chain Measurements Move to Center Stage Clin. Chem., May 1, 2005; 51(5): 805 - 807. [Full Text] [PDF]
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