Freelite Serum Free Light Chain Assays
Freelite™ is a major breakthrough for the detection and monitoring of Multiple Myeloma (MM) and other B-cell dyscrasia. There is now significant clinical evidence indicating the benefit of serum free light chain assays in initial screening for monoclonal gammopathies, identifying AL amyloidosis and Nonsecretory MM patients missed by conventional electrophoretic methods, as a prognostic indicator for progression in myeloma*, for risk stratification of MGUS patients* and rapid evaluation of treatment efficacy.
Freelite assays were developed by Binding Site to measure free lambda and free kappa immunoglobulin light chains. Our expertise in the manufacture of antibodies has enabled us to provide a quantifiable, highly specific, automatable free light chain assay for serum.
In September 2009 Binding Site announced the launch of Hevylite™ - a novel immunoassay panel designed for analysis of immunoglobulin heavy chain/light chain pairs.
Summary of Data
NOTE: Click on the image above to enlarge
Logarithmic scale plot of absolute free kappa (κ) and free lambda (λ) concentrations in a group of normal patients and those with a variety of B cell dyscrasia. Calculation of the / ratio distinguishes elevated polyclonal immunoglobulin and renal impairment (κ/λ ratio is normal) from monoclonal gammopathies with an abnormal / ratio e.g. Lambda and Kappa BJ.
Published data indicate that 100% of patients with Light Chain (Bence Jones) Multiple Myeloma1, 82% of patients with Nonsecretory Multiple Myeloma2, over 98% of patients with AL amyloidosis3 and 96% of Intact Immunoglobulin Multiple Myeloma patients4 have abnormal serum free light chain concentrations. This improvement in disease detection rates, and the superior utility of serum free light chains for disease monitoring, may obviate the need for urine free light chain tests in most patients with monoclonal plasma diseases.
Several recent studies have indicated the use of serum free light chains as an independent marker of prognosis* in multiple myeloma patients5-9. Additionally, the serum free light chain ratio has been identified as a major new independent risk factor for progression of patients with MGUS* to multiple myeloma or other related disorders10.
Serum free light chain assays are included in an increasing number of guidelines for the diagnosis and management of Multiple Myeloma and AL amyloidosis including specific guidelines on their use by the International Myeloma Working Group. They have also been added to the new International uniform response criteria for assessing clinical outcomes in multiple myeloma.
A recent review by Sundar Jagannath, St Vincent's Comprehensive Cancer Center, New York, looks at the value of these assays in haematology11. General information on the use of serum free light chains is also available in a Clinical Chemistry editorial12.
* In the USA diagnostic use of this product is restricted to those stated in the product insert
Freelite Web Site
Freelite has its own web site which includes:
- Clinical Evidence for the application of Freelite in the detection and monitoring of B-cell dyscrasia
- Laboratory Protocols show the comparison of traditional methods and the new serum assays
- Guidelines - published guidelines endorsing the use of Freelite
- Products - availability of assays on a range of clinical analysers
- Hevylite - analysis of immunoglobulin heavy chain/light chain pairs
- FAQs - frequently asked questions on the application of serum free light chain assays
Wikilite.com
A new educational resource with up to date information on:
- Freelite - Serum free light chain analysis
- Hevylite - Heavy chain/light chain analysis
Visit the website at www.wikilite.com
Serum Free Light Chain Analysis 5th Edition
AR Bradwell
Serum Free Light Chain Analysis (Plus Hevylite) 5th Edition
The book is available to order US $75.
Please contact your local office or distributor
References
- Arthur R Bradwell, Hugh D Carr-Smith, Graham P Mead, Timothy C Harvey, Mark T Drayson.
"Serum test for assessment of patients with Bence Jones myeloma"
Lancet 2003;361:489-491 - Mark Drayson, Liang X. Tang, Roger Drew, Graham P. Mead, Hugh Carr-Smith, and Arthur R. Bradwell.
"Serum free light-chain measurements for identifying and monitoring patients with nonsecretory multiple myeloma"
Blood 2001;97:9:2900-2902 - Helen J. Lachmann, Ruth Gallimore, Julian D. Gillmore, Hugh D. Carr-Smith, Arthur R. Bradwell, Mark B. Pepys and Philip N. Hawkins.
"Outcome in systemic AL amyloidosis in relation to changes in concentration of circulating free immunoglobulin light chains following chemotherapy"
BJH 2003;122:78-84 - G. P. Mead, H. D. Carr-Smith, M. T. Drayson, G. J. Morgan, J. A. Child and A. R. Bradwell.
"Serum free light chains for monitoring multiple myeloma"
BJH 2004;126:348-354 - Frits van Rhee, Vanessa Bolejack, Klaus Hollmig, Mauricio Pineda-Roman, Elias Anaissie, Joshua Epstein, John D. Shaughnessy Jr, Maurizio Zangari, Guido Tricot, Abid Mohiuddin, Yazan Alsayed, Gail Woods, John Crowley, and Bart Barlogie
"High serum-free light chain levels and their rapid reduction in response to therapy define an aggressive multiple myeloma subtype with poor prognosis"
Blood, 2007; 110(3):827-832 - Marie-Christine Kyrtsonis, Theodoros P. Vassilakopoulos, Nicoletta Kafasi, Sotirios Sachanas, Tatiana Tzenou, Argiroula Papadogiannis, Zacharoula Galanism Christina Kalpadakis, Maria Dimou, Elias Kyriakou, Maria K. Angelopoulou, Maria N. Dimopoulou, Marina P. Siakantaris, Evangelia M. Dimitriadou, Styliani I. Kokoris, Panayiotis Panayiotidis and Gerassimos A. Pangalis
"Prognostic value of serum free light chain ratio at diagnosis in multiple myeloma"
British Journal of Haematology 2007; 137:240-243 - CLH Snozek, JA Katzmann, RA Kyle, A Dispenzieri, DR Larson, TM Therneau, LJ Melton III, S Kumar, PR Greipp, RJ Clark and SV Rajkumar
"Prognostic value of the serum free light chain ratio in newly diagnosed myeloma: proposed incorporation into the international staging system"
Leukemia advance online publication, 3 July 2008; doi:10.1038/leu.2008.171 - Kyrtsonis et al.
"Serum free light chain measurement aids the diagnosis of myeloma in patients with severe renal failure"
Blood 2007; 110:1490a - Angela Dispenzieri, Robert A. Kyle, Jerry A. Katzmann, Terry M. Therneau, Dirk Larson, Joanne Benson, Raynell J. Clark, L. Joseph Melton III, Morie A. Gertz, Shaji K. Kumar, Rafael Fonseca, Diane F. Jelinek, S. Vincent Rajkumar
"Immunoglobulin free light chain ratio is an independent risk factor for progression of smoldering (asymptomatic) multiple myeloma"
Blood 2008 111(2):785-789 - S.Vincent Rajkumar, Robert A. Kyle, Terry M. Therneau, L. Joseph Melton III, Arthur R. Bradwell, Raynell J. Clark, Dirk R. Larson, Matthew F. Plevak, Angela Dispenzieri, Jerry A. Katzmann.
"Serum free light chain ratio is an independent risk factor for progression in monoclonal gammopathy of undetermined significance (MGUS)"
Blood 2005;106;3: 812-817 - Sundar Jagannath
"Value of Serum Free Light Chain Testing for the Diagnosis and Monitoring of Monoclonal Gammopathies in Hematology."
Clinical Lymphoma and Myeloma 2007 7(8):518-523 - Arthur R. Bradwell.
"Serum Free Light Chain Measurements Move to Center Stage"
Clin Chem 2005;51:5:805-807
Click here to order the reprints listed above (except number 8)
Freelite™ is a trademark of The Binding Site Group Ltd, Birmingham, UK
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