Clinical comparison of new monoclonal antibody-based nephelometric assays for free light chain kappa and lambda to polyclonal antibody-based assays and immunofixation electrophoresis

Hoedemakers, Rein M. J.; Pruijt, J.F.M.; Hol, Suzanne; Teunissen, Elisa; Martens, Henk; Stam, Peter; Melsert, Roel; Velthuis, Henk te

doi:10.1515/cclm.2011.793

Cited by 44 publications

(56 citation statements)

References 18 publications

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“…2 So, although the numbers are small, and therefore not conclusive, both these and our own study support our contention that some clones might be missed by the more limited epitope specificity expected of monoclonal antisera.…”

Section: 3supporting

confidence: 67%

A multicentre study comparing two methods for serum free light chain analysis

et al. 2013

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Background: Serum free light chain analysis is now well established in the investigation of monoclonal gammopathies. In the UK there has, until recently, been a single supplier of kits for such analysis. Recently, a second method using monoclonal antisera was introduced. We have compared the performance of these two kits in four routine laboratories. Method: Samples submitted for routine analysis (327 samples, 258 [79%] from patients with B-cell lymphoproliferative disease) for serum free light chains were tested by both technologies (Freelite, Binding Site and N Latex FLC, Siemens), according to the manufacturers' instructions. Results: Qualitative data were available by both methods on 313 samples for serum free kappa chains and 324 samples for lambda free light chains. We found poor correspondence of 81% for kappa and 74% for lambda. Five percent of samples were significantly discordant in these assays. Conclusions: These assays perform very differently in clinical practice. They cannot be used interchangeably, especially if monitoring patient responses to therapy.

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Section: 3supporting

confidence: 67%

A multicentre study comparing two methods for serum free light chain analysis

et al. 2013

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“…Comparative studies conducted in order to evaluate the concordance between the two assays have produced varied results [20,26,27]. It is therefore recommended that the same method be used, especially for monitoring therapy responses [28,29,30,31,32,33,34].…”

Section: Introductionmentioning

confidence: 99%

Analytical Criticalities Associated to Different Immunological Methods for Serum Free Light Chain Detection in Plasma Cell Dyscrasias: A Description of Particular Clinical Cases

Sabatino

Perrone

Cuomo

et al. 2017

IJMS

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Current criteria for differential diagnosis of multiple myeloma (MM), Monoclonal gammopathy of undetermined significance (MGUS), and smoldering multiple myeloma (SMM) are included in the 2003 guidelines by the International Myeloma Working Group (IMWG). An updated version was then published in 2014, highlighting the importance of serum free light chain (sFLC) detection, as well as the κ/λ ratio as excellent indicators of clonality. At present, two commercial assays for sFLC quantification are available: the Freelite™ assay and the N-Latex assay. The first was developed by The Binding Site based on a mixture of polyclonal antibodies directed against a variety of FLC epitopes. It may be run on a wide range of nephelometers, as well as on turbidimeters. The second method was developed by Siemens and runs exclusively on Siemens instruments. It employs a probe mixture of mouse monoclonal antibodies. The aim of our study was to evaluate sFLC measurement and calculated κ/λ ratio in 85 patients with monoclonal gammopathies (MGs) in order to compare methods. We demonstrated that there is only a moderate concordance between the two FLC assays. In particular, in one case, we observed no qualitative alterations of the serum protein pattern, and in the absence of a Freelite™ assay, sFLC measurement would not have been possible to highlight the increase of λ FLC.

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“…We read with interest the communication from Hoedemakers et al (1) which compared serum free light chain measurements generated using the established polyclonal Freelite ™ assays (The Binding Site Group Ltd, Birmingham, UK), with results from the new N Latex assays, which utilise monoclonal antibodies developed by Reagents Division, Sanquin Blood Supply Foundation (Amsterdam, The Netherlands). The Freelite™ assays have been utilised in many clinical studies which have formed the basis of international guidelines for serum free light chain measurement (2) .…”

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confidence: 99%