Towards improved measurement of serum free light chains: Clinical and laboratory issues

Biochimica Clinica

Volumn 37, Issue 5, 2013, Pages 395-404

  Tate, Jill ^a   Peter, Mollee ^b,c  

^a ROYAL BRISBANE AND WOMEN'S HOSPITAL   (Australia)

^b PRINCESS ALEXANDRA HOSPITAL   (Australia)

^c UNIVERSITY OF QUEENSLAND   (Australia)

Author keywords

[No Author keywords available]

Indexed keywords

IMMUNOGLOBULIN A ANTIBODY; IMMUNOGLOBULIN KAPPA CHAIN; IMMUNOGLOBULIN LAMBDA CHAIN; IMMUNOGLOBULIN LIGHT CHAIN; IMMUNOGLOBULIN M ANTIBODY; MONOCLONAL ANTIBODY; PARAPROTEIN;

ANTIGEN ANTIBODY COMPLEX; ANTIGEN RECOGNITION; CALIBRATOR; CLINICAL LABORATORY; COMPETITIVE INHIBITION; CROSS REACTION; DILUTION; ENZYME LINKED IMMUNOSORBENT ASSAY; FALSE NEGATIVE RESULT; FREE LIGHT CHAIN ASSAY; HEMODIAFILTRATION; HUMAN; HYPERGAMMAGLOBULINEMIA; IMMUNOASSAY; IMMUNOCHEMISTRY; IMMUNOGLOBULIN PRODUCTION; IMMUNOPRECIPITATION; IMMUNOREACTIVITY; INCUBATION TIME; LYMPHOPROLIFERATIVE DISEASE; MONOCLONAL IMMUNOGLOBULINEMIA; NONLINEAR SYSTEM; NOTE; PLASMA CELL; PLASMA CELL DYSCRASIA; POLYMERIZATION; PROTEIN ELECTROPHORESIS; REFERENCE VALUE; SENSITIVITY AND SPECIFICITY; STATISTICAL SIGNIFICANCE;

EID: 84889264886     PISSN: 03930564     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Note

References (60)

1. Drayson M, Tang LX, Drew R, et al. Serum free light-chain measurements for identifying and monitoring patients with nonsecretory multiple myeloma. Blood 2001;97:2900-2.
2. Dispenzieri A, Kyle R, Merlini G, et al. International Myeloma Working Group guidelines for serum-free light chain analysis in multiple myeloma and related disorders. Leukemia 2009;23:215-24.
3. Graziani M, Merlini G, Petrini C for the IFCC Committee on Plasma Proteins and the SIBioC Study Group on Proteins. Guidelines for the analysis of Bence Jones protein. Clin Chem Lab Med 2003;41:338-46.
4. Lavatelli F, Brambilla F, Valentini V, et al. A novel approach for the purification and proteomic analysis of pathogenic immunoglobulin free light chains from serum. Biochim Biophys Acta 2011;1814:409-19.
5. Bradwell AR, Carr-Smith HD, Mead GP, et al. Highly sensitive, automated immunoassay for immunoglobulin free light chains in serum and urine. Clin Chem 2001;47:673-80.
6. Te Velthuis H, Knop I, Stam P, et al. N Latex FLC - new monoclonal high-performance assays for the determination of free light chain kappa and lambda. Clin Chem Lab Med 2011;49:1323-32.
7. Abe M, Goto T, Kennel SJ, et al. Production and immunodiagnostic applications of antihuman light chain monoclonal antibodies. Am J Clin Pathol 1993;100:67-74.
8. Nakano T, Nagata A. ELISAs for free human immunoglobulin light chains in serum: improvement of assay specificity by using two specific antibodies in a sandwich detection method. J Immunol Methods 2004;293:183-9.
9. Davern S, Tang L, Williams T, et al. Immunodiagnostic capabilities of anti-free immunoglobulin light chain monoclonal antibodies. Am J Clin Pathol 2008;130:702-11.
10. Campbell JP, Cobbold M, Wang Y, et al. Development of a highly-sensitive multi-plex assay using monoclonal antibodies for the simultaneous measurement of kappa and lambda immunoglobulin free light chains in serum and urine. J Immunol Methods 2013;391:1-13.
11. Nakano T, Miyazaki S, Takahashi H, et al. Immunochemical quantification of free immunoglobulin light chains from an analytical perspective. Clin Chem Lab Med 2006;44:522-32.
12. Tate JR, Mollee P, Dimeski G, et al. Analytical performance of serum free light-chain assay during monitoring of patients with monoclonal light-chain diseases. Clin Chim Acta 2007;376:30-6.
13. Beetham R, Wassell J, Wallage MJ, et al. Can serum free light chains replace urine electrophoresis in the detection of monoclonal gammopathies? Ann Clin Biochem 2007;44:516-22.
14. Katzmann JA, Kyle RA, Benson J, et al. Screening panels for detection of monoclonal gammopathies. Clin Chem 2009;55:1517-22.
15. Palladini G, Russo P, Bosoni T, et al. Identification of amyloidogenic light chains requires the combination of serum-free light chain assay with immunofixation of serum and urine. Clin Chem 2009;55:499-504.
16. Levinson SS. Polyclonal free light chain of Ig may interfere with interpretation of monoclonal free light chain κ/λ ratio. Ann Clin Lab Sci 2010;40:348-53.
17. Nakano T, Komoda T, Nagata A. To the editor: Author reply; Robson et al. Clin Chem Lab Med 2007;45:264-5.
18. Clin Chem Lab Med 2007;45:266-7.
19. Katzmann JA, Snyder MR, Rajkumar SV, et al. Long-term biological variation of serum protein electrophoresis M-spike, urine M-spike, and monoclonal serum free light chain quantification: implications for monitoring monoclonal gammopathies. Clin Chem 2011;57:1687-92.
20. Hansen CT, Münster A-M, Nielsen L, et al. Clinical and preclinical validation of the serum free light chain assay: identification of the critical difference for optimized clinical use. Eur J Haematol 2012;89:458-68.
21. Braga F, Infusino I, Dolci A, et al. Variabilità biologica delle catene leggere libere delle immunoglobuline nel siero. Biochim Clin 2013;37;376-82.
22. Pretorius CJ, Klingberg S, Tate J, et al. Evaluation of the N Latex FLC free light chain assay on the Siemens BN analyser: precision, agreement, linearity and variation between reagent lots. Ann Clin Biochem 2012;49:450-5.
23. Vercammen M, Meirlaen P, Broodtaerts L, et al. Effect of sample dilution on serum free light chain concentration by immunonephelometric assay. Clin Chim Acta 2011;412:1798-804.
24. Hoedemakers RM, Pruijt JFM, Hol S, et al. Clinical comparison of new monoclonal antibody-based nephelometric assays for free light chain kappa and lambda to polyclonal antibody-based assays and immunofixation electrophoresis. Clin Chem Lab Med 2012:50:489-95.
25. Clark RJ, Lockington KS, Tostrud LJ, et al. Incidence of antigen excess in serum free light chain assays. Clin Chem 2007;53:A148.
26. Daval S, Tridon A, Mazeron N, et al. Risk of antigen excess in serum free light chain measurements. Clin Chem 2007;53:1955-6.
27. Tate J, Bazeley S, Sykes S, et al. Quantitative serum free light chain assay - analytical issues. Clin Biochem Rev 2009;30:131-40.
28. Levinson SS. Hook effect with lambda free light chain in serum free light chain assay. Clin Chim Acta 2010;411:1834-6.
29. Bosmann M, Kößler J, Stolz H, et al. Detection of serum free light chains: the problem with antigen excess. Clin Chem Lab Med 2010;48:1419-22.
30. Murata K, Clark RJ, Lockington KS, et al. Sharply increased serum free light-chain concentrations after treatment for multiple myeloma. Clin Chem 2010;56:16-20.
31. Jacobs JFM, Hoedemakers RM, Teunissen E, et al. Effect of sample dilution on two free light chain nephelometric assays. Clin Chim Acta 2012;413:1708-9.
32. Robson E, Mead G, Carr-Smith H, et al. To the Editor: Author reply; Tate et al. Clin Chim Acta 2007;380:30-6;
33. Clin Chim Acta 2007;380:247.
34. Tate JR, Dimeski G, Carter AC, et al. To the Editor: Author reply; Robson E. et al. Clin Chim Acta 2007;380:247.
35. Clin Chim Acta 2007;380:250-1.
36. Bakker AJ, Bierma-Ram A, Elderman-van der Werf C, et al. Quantitation of serum free light chains. Clin Chem 2009;55:1585-7.
37. Katzmann JA, Clark RJ, Abraham RS, et al. Serum reference intervals and diagnostic ranges for free K and free L immunoglobulin light chains: relative sensitivity for detection of monoclonal light chains. Clin Chem 2002;48:1437-44.
38. Pattenden RJ, Rogers SY, Wenham PR. Serum free light chains; the need to establish local reference intervals. Ann Clin Biochem 2007;44:512-5.
39. rd ed. CLSI document C28-A3. Wayne, PA: CLSI, 2008.
40. Hutchison CA, Harding S, Hewins P, et al. Quantitative assessment of serum and urinary polyclonal free light chains in patients with chronic kidney disease. Clin J Am Soc Nephrol 2008;3:1684-90.
41. Abadie JM, van Hoeven KH, Wells JM. Are renal reference intervals required when screening for plasma cell disorders with serum free light chains and serum protein electrophoresis? Am J Clin Pathol 2009;131:166-71.
42. Marshall G, Tate J, Mollee P. Borderline high serum free light chain κ/λ ratios are seen not only in dialysis patients but also in non-dialysis-dependent renal impairment and inflammatory states. Am J Clin Pathol 2009;132:308-9.
43. Tate J, Bazeley S, Klingberg S, et al. Comparison of the Freelite and N Latex serum free light chain (FLC) assays in chronic kidney disease. Clin Biochem Rev 2012;33:S41.
44. Mead GP, Stubbs PS, Carr-Smith HD, et al. Nephelometric measurement of serum free light chains in nonsecretory myeloma. Clin Chem 2002;48:A23.
45. Abraham RS, Charlesworth MC, Owen BAL, et al. Trimolecular complexes of λ light chain dimers in serum of a patient with multiple myeloma. Clin Chem 2002;48:1805-11.
46. De Kat Angelino CM, Raymakers R, Teunesen MA, et al. Overestimation of serum kappa free light chain concentration by immunonephelometry. Clin Chem 2010;56:1188-90.
47. Jacobs JFM, de Kat Angelino CM, Raymakers R, et al. To the editor: Author reply; Mead GP, Carr-Smith HD. Clin Chem 2010:56:1503-4.
48. Clin Chem 2010;56:1504-5.
49. Pretorius CJ, Ungerer JPJ, Wilgen U, et al. To the editor: Author reply; Katzmann et al. Clin Chem 2010;56:677-9.
50. Clin Chem 2010;56:679-80.
51. Piehler AP, Gulbrandsen N, Kierulf P, et al. 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 2008;54:1823-30.
52. Robson EJD, Taylor J, Beardsmore C, et al. Utility of serum free light chain analysis when screening for lymphoproliferative disorders. Lab Med 2009;40:325-9.
53. Durie BGM, Harousseau J-L, Miguel JS, et al. International uniform response criteria for multiple myeloma. Leukemia 2006;20:1467-73.
54. Rajkumar SV, Harousseau J-L, Durie B. Consensus recommendations for the uniform reporting of clinical trials: report of the International Myeloma Workshop Consensus Panel 1. Blood 2011;117:4691-5.
55. Comenzo RL, Reece D, Palladini G, et al. Consensus guidelines for the conduct and reporting of clinical trials in systemic light-chain (AL) amyloidosis. Leukemia 2012;26:2317-25.
56. Palladini G, Dispenzieri A, Gertz MA, et al. New criteria for response to treatment in immunoglobulin light chain amyloidosis based on free light chain measurement and cardiac biomarkers: impact on survival outcomes. J Clin Oncol 2012;30:4541-9.
57. Lachmann HJ, Gallimore R, Gillmore JD, et al. Outcome in systemic AL amyloidosis in relation to changes in concentration of circulating free immunoglobulin light chains following chemotherapy. Br J Haematol 2003;122:78-84.
58. Kumar SK, Dispenzieri A, Lacy MQ, et al. Changes in serum-free light chain rather than intact monoclonal immunoglobulin levels predicts outcome following therapy in primary amyloidosis. Am J Hematol 2011;86:251-5.
59. Singhal S, Vickrey E, Krishnamurthy J, et al. 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 2009;114:38-9.
60. nd ed. CLSI document EP15-A2. Wayne, PA: CLSI, 2005.