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

Journal of Immunological Methods

Volumn 391, Issue 1-2, 2013, Pages 1-13

  Campbell, John P ^a   Cobbold, Mark ^a   Wang, Yanyun ^a   Goodall, Margaret ^a   Bonney, Sarah L ^a   Chamba, Anita ^a   Birtwistle, Jane ^a   Plant, Timothy ^a   Afzal, Zaheer ^a   Jefferis, Roy ^a   Drayson, Mark T ^a  

^a UNIVERSITY OF BIRMINGHAM   (United Kingdom)

Author keywords

Bence Jones proteins; Multiple myeloma; Plasma cell dyscrasias; Serum free light chains

Indexed keywords

IMMUNOGLOBULIN KAPPA CHAIN; IMMUNOGLOBULIN LAMBDA CHAIN; MONOCLONAL ANTIBODY; POLYSTYRENE;

ARTICLE; CONTROLLED STUDY; ELECTROPHORESIS; HUMAN; IMMUNOASSAY; PRIORITY JOURNAL; SENSITIVITY AND SPECIFICITY; VALIDATION STUDY;

ANIMALS; ANTIBODIES, MONOCLONAL; ANTIBODY SPECIFICITY; BINDING, COMPETITIVE; CALIBRATION; CASE-CONTROL STUDIES; CROSS REACTIONS; HUMANS; IMMUNOASSAY; IMMUNOGLOBULIN KAPPA-CHAINS; IMMUNOGLOBULIN LAMBDA-CHAINS; LINEAR MODELS; MICE; MICE, INBRED BALB C; MULTIPLE MYELOMA; PREDICTIVE VALUE OF TESTS; REFERENCE STANDARDS; REPRODUCIBILITY OF RESULTS; SENSITIVITY AND SPECIFICITY; TUMOR MARKERS, BIOLOGICAL;

OVIS ARIES;

EID: 84876139984     PISSN: 00221759     EISSN: 18727905     Source Type: Journal    
DOI: 10.1016/j.jim.2013.01.014     Document Type: Article

References (39)

1. Abe M., Goto T., Kennel S.J., Wolfenbarger D., Macy S.D., Weiss D.T., Solomon A. Production and immunodiagnostic applications of antihuman light chain monoclonal antibodies. Am. J. Clin. Pathol. 1993, 100:67.
2. Abe M., Goto T., Kosaka M., Wolfenbarger D., Weiss D.T., Solomon A. Differences in kappa to lambda (kappa:lambda) ratios of serum and urinary free light chains. Clin. Exp. Immunol. 1998, 111:457.
3. Abraham R.S., Charlesworth M.C., Owen B.A., Benson L.M., Katzmann J.A., Reeder C.B., Kyle R.A. Trimolecular complexes of lambda light chain dimers in serum of a patient with multiple myeloma. Clin. Chem. 2002, 48:1805.
4. Bergen H.R., Abraham R.S., Johnson K.L., Bradwell A.R., Naylor S. Characterization of amyloidogenic immunoglobulin light chains directly from serum by on-line immunoaffinity isolation. Biomed. Chromatogr. 2004, 18:191.
5. Bradwell A.R. Serum Free Light Chain Analysis (Plus Hevylite) 2008, Binding Site, Birmingham, (www.wikilite.com).
6. Bradwell A.R., Carr-Smith H.D., Mead G.P., Tang L.X., Showell P.J., Drayson M.T., Drew R. Highly sensitive, automated immunoassay for immunoglobulin free light chains in serum and urine. Clin. Chem. 2001, 47:673.
7. Bradwell A.R., Carr-Smith H.D., Mead G.P., Harvey T.C., Drayson M.T. Serum test for assessment of patients with Bence Jones myeloma. Lancet 2003, 361:489.
8. Daval S., Tridon A., Mazeron N., Ristori J.M., Evrard B. Risk of antigen excess in serum free light chain measurements. Clin. Chem. 2007, 53:1985.
9. Davern S., Tang L.X., Williams T.K., Macy S.D., Wall J.S., Weiss D.T., Solomon A. Immunodiagnostic capabilities of anti-free immunoglobulin light chain monoclonal antibodies. Am. J. Clin. Pathol. 2008, 130:702.
10. Dispenzieri A., Kyle R., Merlini G., Miguel J.S., Ludwig H., Hajek R., Palumbo A., Jagannath S., Blade J., Lonial S., Dimopoulos M., Comenzo R., Einsele H., Barlogie B., Anderson K., Gertz M., Harousseau J.L., Attal M., Tosi P., Sonneveld P., Boccadoro M., Morgan G., Richardson P., Sezer O., Mateos M.V., Cavo M., Joshua D., Turesson I., Chen W., Shimizu K., Powles R., Rajkumar S.V., Durie B.G. International Myeloma Working Group guidelines for serum-free light chain analysis in multiple myeloma and related disorders. Leukemia 2009, 23:215.
11. Dispenzieri A., Katzmann J.A., Kyle R.A., Larson D.R., Therneau T.M., Colby C.L., Clark R.J., Mead G.P., Kumar S., Melton L.J., Rajkumar S.V. Use of nonclonal serum immunoglobulin free light chains to predict overall survival in the general population. Mayo Clin. Proc. 2012, 87:517.
12. Drayson M.T. Using single protein biomarkers to predict health and disease in diverse patient populations: a new role for assessment of immunoglobulin free light chains. Mayo Clin. Proc. 2012, 87:505.
13. Drayson M., Carr-Smith H. 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, 50:587.
14. Drayson M., Tang L.X., Drew R., Mead G.P., Carr-Smith H., Bradwell A.R. Serum free light-chain measurements for identifying and monitoring patients with nonsecretory multiple myeloma. Blood 2001, 97:2900.
15. Galfre G., Milstein C. Preparation of monoclonal antibodies: strategies and procedures. Methods Enzymol. 1981, 73:3.
16. Hay F.C., Westwood O.M.R., Nelson P.N., Hudson L. Practical Immunology 2002, Blackwell Science, Oxford.
17. Hoedemakers R.M., Pruijt J.F., Hol S., Teunissen E., Martens H., Stam P., Melsert R., Te Velthuis H. 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.
18. Hutchison C.A., Plant T., Drayson M., Cockwell P., Kountouri M., Basnayake K., Harding S., Bradwell A.R., Mead G. Serum free light chain measurement aids the diagnosis of myeloma in patients with severe renal failure. BMC Nephrol. 2008, 9:11.
19. Hutchison C.A., Cockwell P., Cook M. Diagnostic accuracy of monoclonal antibody based serum immunoglobulin free light chain immunoassays in myeloma cast nephropathy. BMC Clin. Pathol. 2012, 12:12.
20. Jefferis R., Lefranc M.P. Human immunoglobulin allotypes: possible implications for immunogenicity. MAbs 2009, 1:332.
21. Katzmann J.A., Clark R.J., Abraham R.S., Bryant S., Lymp J.F., Bradwell A.R., Kyle R.A. Serum reference intervals and diagnostic ranges for free kappa and free lambda immunoglobulin light chains: relative sensitivity for detection of monoclonal light chains. Clin. Chem. 2002, 48:1437.
22. Krouwer J.S., Tholen D.W., Garber C.C., Goldschmidt H., Kroll M.H., Linnet K., Meier K., Robinowitz M., Kennedy J.W. Method Comparison and Bias Estimation Using Patient Samples; Approved Guideline - Second Edition 2010, CLSI, Wayne, Pa, (Vol.). 2nd edition.
23. Kyle R.A., Therneau T.M., Rajkumar S.V., Larson D.R., Plevak M.F., Offord J.R., Dispenzieri A., Katzmann J.A., Melton L.J. Prevalence of monoclonal gammopathy of undetermined significance. N. Engl. J. Med. 2006, 354:1362.
24. Lachmann H.J., Gallimore R., Gillmore J.D., Carr-Smith H.D., Bradwell A.R., Pepys M.B., Hawkins P.N. 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.
25. Levinson S.S. Hook effect with lambda free light chain in serum free light chain assay. Clin. Chim. Acta 2010, 411:1834.
26. Levinson S.S. Polyclonal free light chain of Ig may interfere with interpretation of monoclonal free light chain kappa/lambda ratio. Ann. Clin. Lab. Sci. 2010, 40:348.
27. Ling N.R., Bishop S., Jefferis Use of antibody-coated red cells for the sensitive detection of antigen and in rosette tests for cells bearing surface immunoglobulins. J. Immunol. Methods 1977, 15:279.
28. McEnroe R.J., Burritt M.F., Powers D.M., Rheinheimer D.W., Wallace B.H. Interference Testing in Clinical Chemistry; Approved Guideline 2005, CLSI, Wayne, Pa. Second edition.
29. Murata K., Clark R.J., Lockington K.S., Tostrud L.J., Greipp P.R., Katzmann J.A. Sharply increased serum free light-chain concentrations after treatment for multiple myeloma. Clin. Chem. 2010, 56:16.
30. Nakano T., Nagata A. ELISAs for free light chains of human immunoglobulins using monoclonal antibodies: comparison of their specificity with available polyclonal antibodies. J. Immunol. Methods 2003, 275:9.
31. Palladini G., Russo P., Bosoni T., Verga L., Sarais G., Lavatelli F., Nuvolone M., Obici L., Casarini S., Donadei S., Albertini R., Righetti G., Marini M., Graziani M.S., Melzi D'Eril G.V., Moratti R., Merlini G. 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.
32. Rajkumar S.V., Kyle R.A., Therneau T.M., Clark R.J., Bradwell A.R., Melton L.J., Larson D.R., Plevak M.F., Katzmann J.A. Presence of monoclonal free light chains in the serum predicts risk of progression in monoclonal gammopathy of undetermined significance. Br. J. Haematol. 2004, 127:308.
33. Sitnikova T., Nei M. Evolution of immunoglobulin kappa chain variable region genes in vertebrates. Mol. Biol. Evol. 1998, 15:50.
34. Solomon A., Weiss D.T. Structural and functional properties of human lambda-light-chain variable-region subgroups. Clin. Diagn. Lab. Immunol. 1995, 2:387.
35. Tate J.R., Mollee P., Dimeski G., Carter A.C., Gill D. Analytical performance of serum free light-chain assay during monitoring of patients with monoclonal light-chain diseases. Clin. Chim. Acta 2007, 376:30.
36. Tate J.R., Bazeley S., Sykes S., Mollee P. Quantitative serum free light chain assay-analytical issues. Clin. Biochem. Rev. 2009, 30:131.
37. te Velthuis H., Knop I., Stam P., van den Broek M., Bos H.K., Hol S., Teunissen E., Fischedick K.S., Althaus H., Schmidt B., Wagner C., Melsert R. 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.
38. Tholen D.W., Kallner A., Kennedy J.W., Krouwer J.S., Meier K. Evaluation of Precision Performance of Quantitative Measurement Methods: Approved Guideline 2004, CLSI, Wayne, Pa.
39. Waldmann T.A., Strober W., Mogielnicki R.P. The renal handling of low molecular weight proteins. II. Disorders of serum protein catabolism in patients with tubular proteinuria, the nephrotic syndrome, or uremia. J. Clin. Invest. 1972, 51:2162.