Publications by authors named "Ellen L Jenner"

4 Publications

  • Page 1 of 1

Remediation of IgG4 Cross-Reactivity in IgG1 and IgG2 Subclass Assays.

Clin Chem 2018 08 6;64(8):1253-1255. Epub 2018 Jun 6.

Department of Research and Development The Binding Site Group Ltd. Birmingham, UK

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http://dx.doi.org/10.1373/clinchem.2018.289124DOI Listing
August 2018

Serum Free Light Chain (FLC) Analysis: A Guiding Light in Monoclonal Gammopathy Management.

J Appl Lab Med 2017 Jul;2(1):98-106

The Binding Site Group, Birmingham, UK.

Background: Monoclonal free light chains (FLCs) were first reported by Dr. Henry Bence Jones over 150 years ago in the urine of patients with multiple myeloma. Now established as important tumor markers, they aid not only in the diagnosis of monoclonal gammopathies but also in their clinical management by indicating the response to treatment and persistence of residual disease.

Content: A particular focus over the past 15 years has been on the replacement of urine with serum analysis for monoclonal FLC measurement. Because of the limited sensitivity and practical constraints of urine assessment, a combination of serum electrophoresis and serum FLC analysis has been adopted by many laboratories as a first-line screen for patients with a suspected monoclonal gammopathy. Early myeloma diagnosis may translate into improved clinical outcomes, and a new study, iStopMM, is underway to ascertain the benefit of population-wide screening protocols for early detection of the disease in its asymptomatic phase. Laboratory algorithms that include measurement of both monoclonal intact immunoglobulins and FLCs are important for assessing possible changes in myelomic clones in response to treatment, and recent data from Intergroupe Francophone du Myelome trials validate serum FLC as a clinically relevant disease biomarker. Whether sensitive serum techniques such as FLC analysis can be used to guide the use of more invasive procedures for detection of minimal residual disease is the subject of emerging studies.

Summary: Here we review the current and evolving utility of serum FLC measurements for the management of patients with monoclonal gammopathies.
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http://dx.doi.org/10.1373/jalm.2016.021352DOI Listing
July 2017

Analytical issues of serum free light chain assays and the relative performance of polyclonal and monoclonal based reagents.

Clin Chem Lab Med 2016 Jun;54(6):997-1003

Serum free light chain (FLC) assays have been incorporated into routine clinical practice and their use is recommended in international guidelines for the management of monoclonal gammopathies. Given that FLCs are not simple analytes, laboratories should be aware of potential analytical issues when using FLC assays, including antigen excess, lot-to-lot variation and non-linearity. Whilst manufacturers of monoclonal antibody-based assays claim that they overcome such issues, the evidence available to date does not support this. Here we review and compare the technical performance of both polyclonal and monoclonal antibody-based assays. The evidence suggests that the Freelite assay, based on polyclonal antisera, gives a broader recognition of monoclonal FLCs than the N Latex assay, based on monoclonal antisera, and despite being cited as a technical concern, we show that lot-to-lot variation of the Freelite assay is good. Both non-linearity and antigen excess are characteristic of FLC analysis and laboratories should be aware of these phenomena regardless of the assay system they use. Comparisons of the absolute values of sFLCs determined using monoclonal and polyclonal antibody-based assays show poor quantitative agreement and, because current guidelines have been established using the polyclonal antibody-based Freelite assay, it should not be assumed that assays utilizing monoclonal antibodies will give compliance with these guidelines.
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http://dx.doi.org/10.1515/cclm-2015-1068DOI Listing
June 2016

Quantification of β-region IgA monoclonal proteins - should we include immunochemical Hevylite® measurements? Point.

Clin Chem Lab Med 2016 Jun;54(6):1053-7

Accurate measurement of IgA monoclonal proteins presents a significant challenge to laboratory staff. IgA heavy/light chain (Hevylite, HLC) analysis is an alternative methodology for monoclonal protein assessment, giving an independent measure of IgAκ and IgAλ concentrations. Clonality is assessed by calculating the ratio of involved immunoglobulin to background uninvolved immunoglobulin concentrations (e.g. IgAκ/IgAλ in an IgAκ patient). Here we discuss the challenges faced by the laboratory in IgA monoclonal protein assessment, and compare the performance of Hevylite assays with electrophoresis and total IgA results. We present data which validates the use of Hevylite for response assessment: in most cases, Hevylite provides comparable response assignment to that provided by serum protein electrophoresis (SPE) and total IgA; in other cases Hevylite provides additional information, such as detection of residual disease or relapse.
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http://dx.doi.org/10.1515/cclm-2015-0696DOI Listing
June 2016