Validation of a rapid lateral-flow test for the diagnosis and monitoring of immunoglobulin free light chains: Retrospective analysis of sera from patients with plasma cell dyscrasias

J. Campbell, A. Stride, J. Heaney, M. Cobbold, Y. Wang, M. Goodall, S. Bonney, A. Chamba, T. Plant, Z. Afzal, R. Jefferies, M. Drayson

Research output: Contribution to journalMeeting abstract

31 Citations (Scopus)

Abstract

Background: Quantitation of serum κ and λ immunoglobulin free light chains (FLC) is central to the diagnosis and monitoring of patients with plasma cell dyscrasias, including multiple myeloma. At present, laboratory FLC tests offer the only means of quantitating FLC in urine and blood and often have a slow turnaround time that prevents early myeloma diagnosis or identification of relapse. We have developed a rapid lateral-flow test (Seralite™) that simultaneously quantitates kappa and lambda FLCs in blood or urine in 10 minutes using highly-specific anti-κ and anti-λ FLC monoclonal antibodies (Campbell et al., 2013 JIM). Methods: Seralite™ validation was conducted by retrospective analysis of sera from patients with plasma cell dyscrasias from MRC UK Myeloma IX and XI trials. Specifically, 1,975 (MIX n=1,231, MXI n=744) samples at trial entry were used to assess the utility of Seralite™ for diagnosis. Results: Seralite™ displayed excellent clinical concordance with Freelite™ and immunofixation electrophoresis for identification of abnormal FLC levels. Additionally, cohorts of samples from patients with light chain only myeloma, nonsecretory myeloma, and intact immunoglobulin myeloma (IgAκ/λ, IgGκ/λ, IgMκ/λ, IgDκ/λ) were assessed through diagnosis, response to therapy, plateau and relapse. Seralite had excellent concordance with Freelite™ for the quantitation of serum FLC from diagnosis through monitoring. Conclusion: Prospective use of Seralite™ to diagnose and monitor plasma cell dyscrasias at the point-of-care should now be investigated.
Original languageEnglish
Pages (from-to)14
Number of pages1
JournalClinical Chemistry
Volume59
Issue number10
Publication statusPublished - 1 Oct 2013

Fingerprint

Immunoglobulin Light Chains
Paraproteinemias
Immunoglobulins
Plasmas
Light
Monitoring
Serum
Point-of-Care Systems
Urine
Blood
Recurrence
Physiologic Monitoring
Turnaround time
Multiple Myeloma
Electrophoresis
Early Diagnosis
Monoclonal Antibodies

Keywords

  • immunoglobulin
  • immunoglobulin D
  • immunoglobulin M
  • immunoglobulin G
  • immunoglobulin A
  • monoclonal antibody
  • monitoring
  • light chain
  • serum
  • patient
  • human
  • plasma cell dyscrasia
  • American
  • clinical chemistry
  • diagnosis
  • myeloma
  • relapse
  • blood
  • urine
  • turnaround time
  • therapy
  • laboratory
  • multiple myeloma
  • electrophoresis
  • United Kingdom

Cite this

Validation of a rapid lateral-flow test for the diagnosis and monitoring of immunoglobulin free light chains: Retrospective analysis of sera from patients with plasma cell dyscrasias. / Campbell, J.; Stride, A.; Heaney, J.; Cobbold, M.; Wang, Y.; Goodall, M.; Bonney, S.; Chamba, A.; Plant, T.; Afzal, Z.; Jefferies, R.; Drayson, M.

In: Clinical Chemistry, Vol. 59, No. 10, 01.10.2013, p. 14.

Research output: Contribution to journalMeeting abstract

Campbell, J, Stride, A, Heaney, J, Cobbold, M, Wang, Y, Goodall, M, Bonney, S, Chamba, A, Plant, T, Afzal, Z, Jefferies, R & Drayson, M 2013, 'Validation of a rapid lateral-flow test for the diagnosis and monitoring of immunoglobulin free light chains: Retrospective analysis of sera from patients with plasma cell dyscrasias', Clinical Chemistry, vol. 59, no. 10, pp. 14.
Campbell, J. ; Stride, A. ; Heaney, J. ; Cobbold, M. ; Wang, Y. ; Goodall, M. ; Bonney, S. ; Chamba, A. ; Plant, T. ; Afzal, Z. ; Jefferies, R. ; Drayson, M. / Validation of a rapid lateral-flow test for the diagnosis and monitoring of immunoglobulin free light chains: Retrospective analysis of sera from patients with plasma cell dyscrasias. In: Clinical Chemistry. 2013 ; Vol. 59, No. 10. pp. 14.
@article{30d2a20faa3f4968a1205e1fc94e872b,
title = "Validation of a rapid lateral-flow test for the diagnosis and monitoring of immunoglobulin free light chains: Retrospective analysis of sera from patients with plasma cell dyscrasias",
abstract = "Background: Quantitation of serum κ and λ immunoglobulin free light chains (FLC) is central to the diagnosis and monitoring of patients with plasma cell dyscrasias, including multiple myeloma. At present, laboratory FLC tests offer the only means of quantitating FLC in urine and blood and often have a slow turnaround time that prevents early myeloma diagnosis or identification of relapse. We have developed a rapid lateral-flow test (Seralite™) that simultaneously quantitates kappa and lambda FLCs in blood or urine in 10 minutes using highly-specific anti-κ and anti-λ FLC monoclonal antibodies (Campbell et al., 2013 JIM). Methods: Seralite™ validation was conducted by retrospective analysis of sera from patients with plasma cell dyscrasias from MRC UK Myeloma IX and XI trials. Specifically, 1,975 (MIX n=1,231, MXI n=744) samples at trial entry were used to assess the utility of Seralite™ for diagnosis. Results: Seralite™ displayed excellent clinical concordance with Freelite™ and immunofixation electrophoresis for identification of abnormal FLC levels. Additionally, cohorts of samples from patients with light chain only myeloma, nonsecretory myeloma, and intact immunoglobulin myeloma (IgAκ/λ, IgGκ/λ, IgMκ/λ, IgDκ/λ) were assessed through diagnosis, response to therapy, plateau and relapse. Seralite had excellent concordance with Freelite™ for the quantitation of serum FLC from diagnosis through monitoring. Conclusion: Prospective use of Seralite™ to diagnose and monitor plasma cell dyscrasias at the point-of-care should now be investigated.",
keywords = "immunoglobulin, immunoglobulin D, immunoglobulin M, immunoglobulin G, immunoglobulin A, monoclonal antibody, monitoring, light chain, serum, patient, human, plasma cell dyscrasia, American, clinical chemistry, diagnosis, myeloma, relapse, blood, urine, turnaround time, therapy, laboratory, multiple myeloma, electrophoresis, United Kingdom",
author = "J. Campbell and A. Stride and J. Heaney and M. Cobbold and Y. Wang and M. Goodall and S. Bonney and A. Chamba and T. Plant and Z. Afzal and R. Jefferies and M. Drayson",
year = "2013",
month = "10",
day = "1",
language = "English",
volume = "59",
pages = "14",
journal = "Clinical Chemistry",
issn = "0009-9147",
publisher = "American Association for Clinical Chemistry Inc.",
number = "10",

}

TY - JOUR

T1 - Validation of a rapid lateral-flow test for the diagnosis and monitoring of immunoglobulin free light chains: Retrospective analysis of sera from patients with plasma cell dyscrasias

AU - Campbell, J.

AU - Stride, A.

AU - Heaney, J.

AU - Cobbold, M.

AU - Wang, Y.

AU - Goodall, M.

AU - Bonney, S.

AU - Chamba, A.

AU - Plant, T.

AU - Afzal, Z.

AU - Jefferies, R.

AU - Drayson, M.

PY - 2013/10/1

Y1 - 2013/10/1

N2 - Background: Quantitation of serum κ and λ immunoglobulin free light chains (FLC) is central to the diagnosis and monitoring of patients with plasma cell dyscrasias, including multiple myeloma. At present, laboratory FLC tests offer the only means of quantitating FLC in urine and blood and often have a slow turnaround time that prevents early myeloma diagnosis or identification of relapse. We have developed a rapid lateral-flow test (Seralite™) that simultaneously quantitates kappa and lambda FLCs in blood or urine in 10 minutes using highly-specific anti-κ and anti-λ FLC monoclonal antibodies (Campbell et al., 2013 JIM). Methods: Seralite™ validation was conducted by retrospective analysis of sera from patients with plasma cell dyscrasias from MRC UK Myeloma IX and XI trials. Specifically, 1,975 (MIX n=1,231, MXI n=744) samples at trial entry were used to assess the utility of Seralite™ for diagnosis. Results: Seralite™ displayed excellent clinical concordance with Freelite™ and immunofixation electrophoresis for identification of abnormal FLC levels. Additionally, cohorts of samples from patients with light chain only myeloma, nonsecretory myeloma, and intact immunoglobulin myeloma (IgAκ/λ, IgGκ/λ, IgMκ/λ, IgDκ/λ) were assessed through diagnosis, response to therapy, plateau and relapse. Seralite had excellent concordance with Freelite™ for the quantitation of serum FLC from diagnosis through monitoring. Conclusion: Prospective use of Seralite™ to diagnose and monitor plasma cell dyscrasias at the point-of-care should now be investigated.

AB - Background: Quantitation of serum κ and λ immunoglobulin free light chains (FLC) is central to the diagnosis and monitoring of patients with plasma cell dyscrasias, including multiple myeloma. At present, laboratory FLC tests offer the only means of quantitating FLC in urine and blood and often have a slow turnaround time that prevents early myeloma diagnosis or identification of relapse. We have developed a rapid lateral-flow test (Seralite™) that simultaneously quantitates kappa and lambda FLCs in blood or urine in 10 minutes using highly-specific anti-κ and anti-λ FLC monoclonal antibodies (Campbell et al., 2013 JIM). Methods: Seralite™ validation was conducted by retrospective analysis of sera from patients with plasma cell dyscrasias from MRC UK Myeloma IX and XI trials. Specifically, 1,975 (MIX n=1,231, MXI n=744) samples at trial entry were used to assess the utility of Seralite™ for diagnosis. Results: Seralite™ displayed excellent clinical concordance with Freelite™ and immunofixation electrophoresis for identification of abnormal FLC levels. Additionally, cohorts of samples from patients with light chain only myeloma, nonsecretory myeloma, and intact immunoglobulin myeloma (IgAκ/λ, IgGκ/λ, IgMκ/λ, IgDκ/λ) were assessed through diagnosis, response to therapy, plateau and relapse. Seralite had excellent concordance with Freelite™ for the quantitation of serum FLC from diagnosis through monitoring. Conclusion: Prospective use of Seralite™ to diagnose and monitor plasma cell dyscrasias at the point-of-care should now be investigated.

KW - immunoglobulin

KW - immunoglobulin D

KW - immunoglobulin M

KW - immunoglobulin G

KW - immunoglobulin A

KW - monoclonal antibody

KW - monitoring

KW - light chain

KW - serum

KW - patient

KW - human

KW - plasma cell dyscrasia

KW - American

KW - clinical chemistry

KW - diagnosis

KW - myeloma

KW - relapse

KW - blood

KW - urine

KW - turnaround time

KW - therapy

KW - laboratory

KW - multiple myeloma

KW - electrophoresis

KW - United Kingdom

M3 - Meeting abstract

VL - 59

SP - 14

JO - Clinical Chemistry

JF - Clinical Chemistry

SN - 0009-9147

IS - 10

ER -