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Clinical Chemistry and Laboratory Medicine (CCLM)

Published in Association with the European Federation of Clinical Chemistry and Laboratory Medicine (EFLM)

Editor-in-Chief: Plebani, Mario

Ed. by Gillery, Philippe / Lackner, Karl J. / Lippi, Giuseppe / Melichar, Bohuslav / Payne, Deborah A. / Schlattmann, Peter / Tate, Jillian R.

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1437-4331
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Volume 55, Issue 3

Issues

Development of a rapid and quantitative lateral flow assay for the simultaneous measurement of serum κ and λ immunoglobulin free light chains (FLC): inception of a new near-patient FLC screening tool

John P. Campbell / Jennifer L.J. Heaney / Meena Shemar / Dene Baldwin / Ann E. Griffin / Emma Oldridge / Margaret Goodall / Zaheer Afzal / Tim Plant / Mark Cobbold
  • Clinical Immunology, University of Birmingham, Birmingham, UK
  • Harvard University Medical School, Massachusetts General Hospital, Boston, MA, USA
  • Other articles by this author:
  • De Gruyter OnlineGoogle Scholar
/ Roy Jefferis / Joannes F.M. Jacobs
  • Department of Laboratory Medicine, Laboratory Medical Immunology, Radboud University Medical Center, Nijmegen, The Netherlands
  • Other articles by this author:
  • De Gruyter OnlineGoogle Scholar
/ Christopher Hand / Mark T. Drayson
Published Online: 2016-08-09 | DOI: https://doi.org/10.1515/cclm-2016-0194

Abstract

Background:

Serum free light chains (FLC) are sensitive biomarkers used for the diagnosis and management of plasma cell dyscrasias, such as multiple myeloma (MM), and are central to clinical screening algorithms and therapy response criteria. We have developed a portable, near-patient, lateral-flow test (Seralite®) that quantitates serum FLC in 10 min, and is designed to eliminate sample processing delays and accelerate decision-making in the clinic.

Methods:

Assay interference, imprecision, lot-to-lot variability, linearity, and the utility of a competitive-inhibition design for the elimination of antigen-excess (‘hook effect’) were assessed. Reference ranges were calculated from 91 healthy donor sera. Preliminary clinical validation was conducted by retrospective analysis of sera from 329 patients. Quantitative and diagnostic results were compared to Freelite®.

Results:

Seralite® gave a broad competitive-inhibition calibration curve from below 2.5 mg/L to above 200 mg/L, provided good assay linearity (between 1.6 and 208.7 mg/L for κ FLC and between 3.5 and 249.7 mg/L for λ FLC) and sensitivity (1.4 mg/L for κ FLC and 1.7 mg/L for λ FLC), and eliminated anomalous results from antigen-excess. Seralite® gave good diagnostic concordance with Freelite® (Roche Hitachi Cobas C501) identifying an abnormal FLC ratio and FLC difference in 209 patients with newly diagnosed MM and differentiating these patients from normal healthy donors with polyclonal FLC.

Conclusions:

Seralite® sensitively quantitates FLC and rapidly identifies clinical conditions where FLC are abnormal, including MM.

This article offers supplementary material which is provided at the end of the article.

Keywords: free light chains; multiple myeloma; near-patient testing

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About the article

aJohn P. Campbell and Jennifer L.J. Heaney contributed equally to this work.


Received: 2016-03-08

Accepted: 2016-07-07

Published Online: 2016-08-09

Published in Print: 2017-03-01


Author contributions: All the authors have accepted responsibility for the entire content of this submitted manuscript and approved submission.

Research funding: Seralite® development was funded by Abingdon Health Ltd. J.H. receives research funding from Abingdon Health Ltd.

Employment or leadership: M.S., A.G., E.O. and D.B. are, or were, employees of Abingdon Health Ltd. M.D. has, and R.J. has previously had, an advisory role with Abingdon Health Ltd. J.C., M.G., R.J., M.C., T.P., C.H. and M.D. have shares in Abingdon Health Ltd.

Honorarium: None declared.

Competing interests: The funding organization(s) played no role in thestudy design; in the collection, analysis, and interpretationof data; in the writing of the report; or in the decision to submit the report for publication.


Citation Information: Clinical Chemistry and Laboratory Medicine (CCLM), Volume 55, Issue 3, Pages 424–434, ISSN (Online) 1437-4331, ISSN (Print) 1434-6621, DOI: https://doi.org/10.1515/cclm-2016-0194.

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