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Welcome to InSite in which you will see that we have launched the first in the range of Hevylite™ assays. The publication review section summarises the first publications featuring Hevylite and also highlights publications for Freelite™ where the κ/λ renal reference range is discussed.
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2009 Issue 8 |
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Exhibitions and Meetings - Catching up and planning ahead |
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The Binding Site Group Ltd |
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Þ Review of Renal Week and ASH Þ Review of publications Þ The latest information on both Freelite and Hevylite Þ Information on the upcoming 6th International Symposium on Clinical Applications of Serum Free Light Chain Analysis (Previously held in Bath, 2008) |
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What’s in Issue 9 |
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Hevylite publications
Assessment of monoclonal gammopathies by nephelometric measurement of individual immunoglobulin kappa/lambda ratios Arthur R. Bradwell, Stephen J. Harding, Nicolas J. Fourrier, Gregg L.F. Wallis, Mark T. Drayson, Hugh D. Carr-Smith and Graham P. Mead (2009). Clin Chem 55(9): 1646-55. Click here to order your copy - MKG536
Heavy/Light-chain analysis of monoclonal gammopathies David F. Keren (2009) Clin Chem 55(9): 1606-8. Click here to order your copy - MKG537
For the first time, Bradwell et al. describe the development of automatic nephelometric immunoassays (Hevylite) that quantify the separate light chain types of each of the intact immunoglobulin classes (IgGκ, IgGλ, IgAκ, IgAλ, IgMκ and IgMλ). Hevylite assays showed lower analytical sensitivity for monoclonal IgG detection but similar or greater sensitivity for IgA and IgM, particularly when the monoclonal bands overlaid transferrin. Hevylite assays demonstrated clinical utility in monitoring Multiple Myeloma patients as Igκ/Igλ ratios were sometimes more sensitive than IFE, provided numerical results and correlated with changes in disease.
In an editorial in the same edition of Clinical Chemistry, David F. Keren, a recognised key opinion leader in serum electrophoretic techniques, reviews the current methods of M-protein investigation and their limitations and discusses the potential of the new Hevylite assays. He comments that measurement of the Hevylite Igκ/Igλ ratio may fare as well as the free κ/λ ratio in providing useful information, provides greater sensitivity than SPE alone, and renders a value that should be reproducible from one laboratory to another” and that the Hevylite assay is “an important addition to our armamentarium for detecting and measuring M-proteins”.
Freelite Publications
Screening
Screening panels for detection of monoclonal gammopathies Jerry A. Katzmann, Robert A. Kyle, Joanne Benson, Dirk R. Larson, Melissa R. Snyder, John A. Lust, S. Vincent Rajkumar and Angela Dispenzieri (2009). Clin Chem 55(8): 1517-22. Click here to order your copy - MKG535
Serum free light chain assay reduces the need for serum and urine immunofixation electrophoresis in the evaluation of monoclonal gammopathy Richard B. Fulton and Suran L. Fernando (2009). Ann Clin Biochem 46(Pt 5): 407-12.
In a recent study from the Mayo Clinic, Katzmann et al. publish the largest study to date to investigate different screening panels for the detection of monoclonal gammopathies. In 1877 patients, with a variety of plasma cell disorders, the authors demonstrate that serum protein electrophoresis (SPE) plus serum free light chain (FLC) tests provide a simple and efficient initial diagnostic screen, enabling urine studies and serum immunofixation (IFE) to be ordered more selectively.
Similarly, Fulton et al. examine the optimal combination of laboratory tests to screen for monoclonal gammopathy. By changing from a strategy where specific assays were requested by clinicians to a standardised protocol which utilised SPE, serum FLC and restricted the use of IFE, the detection of Monoclonal (M)-proteins was maximised whilst significant reductions in labour costs were made.
Renal reference range
Borderline high serum free light chain kappa/lambda ratios are seen not only in dialysis patients but also in non-dialysis-dependent renal impairment and inflammatory states G. Marshall, J. Tate and P. Mollee (2009). Am J Clin Pathol 132(2): 309.
In this letter to the editor, Marshall et al. discuss the findings of their audit of borderline κ/λ FLC ratios. 47/955 patients (4.9%) had a borderline abnormal FLC ratio and no known plasma cell disorder. In all cases, the κ/λ ratio was borderline high (1.67 – 3.2) and 70% of cases (33/47) had an estimated glomerular filtration rate of less than 50 mL/min/1.73 m2. In addition 55% (26/47) had serum protein electrophoresis suggestive of an inflammatory process. This analysis confirms previous findings that renal reference intervals are required when interpreting FLC assay results. In addition, they suggest that borderline low FLC ratios are uncommonly due to inflammatory states or renal impairment and should provoke a thorough search for plasma cell dyscrasias and lymphoproliferative disease. |
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Publication review – keep up to date with recent publications |
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Don’t forget to visit our webinars page regularly to view the webinars. We have recently added a webinar entitled: The New IMWG Guidelines and Assessing Response in Multiple Myeloma, presented by Dr Sagar Lonial, Associate Professor, Winship Cancer Institute, Atlanta, GA, USA. |
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Webinars |
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International Marketing Manager - Freelite & Hevylite |
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Find out more about serum free light chains at www.freelite.co.uk |
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Previous editions of InSite can also be read online here. |
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Next key meetings Visit us at Renal week to discuss more about the renal κ/λ reference range Renal Week 2009, 42nd Annual Meeting & Scientific Exposition, October 27 - November 1 2009, San Diego Convention Center, San Diego, CA http://www.asn-online.org/education_and_meetings/renal_week/
Visit us at ASH to discuss more about the International Myeloma Working Group Guidelines and also what Hevylite can offer you. 51st ASH Annual Meeting and Exposition, December 5-8, 2009, |
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Binding Site is pleased to announce the launch of Hevylite. This novel immunoassay panel is designed for analysis of immunoglobulin heavy chain/light chain pairs. As with Freelite, Hevylite will be used in monitoring patients with Multiple Myeloma and other B cell dyscrasias.
Hevylite is a panel of immunoassays using polyclonal antibodies targeted at the unique junctional epitopes between the heavy chain and light chain constant regions of intact immunoglobulins. The immunoassays can identify, separately, the different light chain types of each immunoglobulin class i.e. IgAκ, IgAλ, IgGκ, IgGλ, IgMκ and IgMλ. These molecules are then measured in pairs, e.g. IgAκ/IgAλ, to produce ratios of involved immunoglobulin/uninvolved immunoglobulin concentrations, in the same manner as serum free light chain κ/λ ratios (Freelite). The first of the assays for measurement of IgAκ/IgAλ is now available for use on the Siemens BN™II chemistry analyser (other Hevylite kits will follow in 2010).
Paul Duncan, Chief Executive Officer of The Binding Site Group Limited, said:
"The introduction of Freelite has revolutionised the monitoring of patients with Multiple Myeloma and other B cell dyscrasias. Hevylite will further enhance the management of these patients."
More information on Hevylite including clinical information and publications is available on our website.
Hevylite is CE marked for In Vitro use in most European countries. In the USA, Hevylite kits are currently available as Research Use Only. |
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First Hevylite assays are now available |
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Healthcare professional viewpoint |
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“We use both [Freelite ratio and absolute values in the screening and diagnostic algorithm]. I like the quantification and think it is helpful. This is particularly true for clinical trials because some patients may have oligosecretory disease, and it is tremendously tough to deny patients access to a trial simply because they ‘don’t have a measurable protein’. Freelite testing gives us that capability [to measure the low levels of protein], which is a very important advance for our patients since the actual incidence of true non-secretory myeloma is very rare.”
Paul Richardson, MD. Clinical Director, Dana Farber Cancer Institute’s Jerome Lipper Center for Multiple Myeloma. |
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If you don’t already have a copy of the new guidelines please click here to request your copy (Code MKG492)
Spotlight Review. International Myeloma Working Group guidelines for serum-free light chain analysis in multiple myeloma and related disorders Dispenzieri et al Leukemia (2009) 23,215-224; doi:10.1038/leu.2008.307
The key recommendations are:-
1. ‘The serum FLC assay in combination with serum PEL and serum IFE is sufficient to screen for pathological monoclonal plasmaproliferative disorders other than AL which requires all the serum tests as well as 24 h urine IFE.’ 2. ‘The serum FLC assay should be measured at diagnosis for all patients with MGUS, smoldering or active multiple myeloma. Solitary plasmacytoma and AL amyloidosis.’ 3. ‘Serial FLC ascertainment should be routinely performed in patients with AL amyloidosis and multiple myeloma patients with oligosecretory disease.’ 4. ‘It should also be done in all patients who have achieved a CR to determine whether they have attained a stringent CR.’ |
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New guidelines available as reprints |
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BN™II is a trademark of Siemens Healthcare Diagnostics Inc. |