New rapid urine test for the identification and quantitation of immunoglobulin free light chains (Bence Jones Proteins)

J. Campbell, J. Heaney, P. Patel, M. Goodall, M. Drayson

Research output: Contribution to journalMeeting abstract

Abstract

Background. Monoclonal κ and λ immunoglobulin free light chains (FLC) in the urine are important biomarkers for the diagnosis and monitoring of a number of plasma cell dyscrasias including multiple myeloma. To date, laboratory FLC tests provide the only means of quantitating FLC and often have a slow turnaround time that prevents early diagnosis or prompt identification of changes in disease activity. Furthermore, the gold standards for identifying (immunofixation electrophoresis; IFE) and quantitating (densitometry) FLC in the urine have a number of limitations. IFE lacks analytical sensitivity (LOD >10-20 mg/L) and interpretation is often subjective. Densitometry has high inter-test variability that contributes to an inter-lab CV% of 50- 95% in the UK National External Quality Assessment Service (NEQAS), and is poorly sensitive meaning that urines need to be concentrated before measurement, sometimes up to 150-fold. Further, clinical manifestations such as proteinuria may obscure monoclonal FLC bands and makes identification and quantitation of monoclonal protein bands inaccurate. Therefore, we have developed a rapid test (Seralite®) that identifies abnormal FLC levels in unconcentrated urine or blood in 10 minutes. Seralite® quantitates κ and λ FLC levels simultaneously using highly specific anti-κ and anti-λ FLC monoclonal antibodies. Methods: Seralite® validation was conducted by retrospective analysis of urine from patients presenting with multiple myeloma (n=100). All samples were also measured for FLC by electrophoresis immunofixation; densitometry on concentrated urines; and a recently validated new Luminex assay that incorporates the same mAbs as Seralite®. Results: Seralite® displayed excellent clinical concordance with Luminex. Analysis of IFE results revealed that Seralite® had no false negatives, and correlated excellently with densitometry. Conclusion: Seralite® detected all FLC in urine from 100 myeloma patients at diagnosis. Prospective use of Seralite® to diagnose and monitor plasma cell dyscrasias including multiple myeloma should now be investigated. The utility of Seralite® in the context of other FLC related disorders including AL amyloidosis should also be established.
LanguageEnglish
Pages6
Number of pages1
JournalClinical Chemistry
Volume60
Issue number10
StatusPublished - 1 Jan 2014

Fingerprint

Bence Jones Protein
Immunoglobulin Light Chains
Immunoglobulins
Urine
Light
Densitometry
Multiple Myeloma
Paraproteinemias
Electrophoresis
Plasmas
Amyloidosis
Turnaround time
Proteinuria
Biomarkers
Early Diagnosis
Monoclonal Antibodies
Assays
Blood

Keywords

  • immunoglobulin
  • Bence Jones protein
  • monoclonal antibody
  • biological marker
  • protein
  • urinalysis
  • light chain
  • American
  • clinical chemistry
  • urine
  • densitometry
  • multiple myeloma
  • diagnosis
  • electrophoresis
  • plasma cell dyscrasia
  • human
  • patient
  • United Kingdom
  • gold standard
  • amyloidosis
  • disease activity
  • early diagnosis
  • myeloma
  • turnaround time
  • monitoring
  • laboratory
  • blood
  • rapid test
  • proteinuria
  • quality control
  • assay
  • diseases

Cite this

New rapid urine test for the identification and quantitation of immunoglobulin free light chains (Bence Jones Proteins). / Campbell, J.; Heaney, J.; Patel, P.; Goodall, M.; Drayson, M.

In: Clinical Chemistry, Vol. 60, No. 10, 01.01.2014, p. 6.

Research output: Contribution to journalMeeting abstract

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T1 - New rapid urine test for the identification and quantitation of immunoglobulin free light chains (Bence Jones Proteins)

AU - Campbell, J.

AU - Heaney, J.

AU - Patel, P.

AU - Goodall, M.

AU - Drayson, M.

PY - 2014/1/1

Y1 - 2014/1/1

N2 - Background. Monoclonal κ and λ immunoglobulin free light chains (FLC) in the urine are important biomarkers for the diagnosis and monitoring of a number of plasma cell dyscrasias including multiple myeloma. To date, laboratory FLC tests provide the only means of quantitating FLC and often have a slow turnaround time that prevents early diagnosis or prompt identification of changes in disease activity. Furthermore, the gold standards for identifying (immunofixation electrophoresis; IFE) and quantitating (densitometry) FLC in the urine have a number of limitations. IFE lacks analytical sensitivity (LOD >10-20 mg/L) and interpretation is often subjective. Densitometry has high inter-test variability that contributes to an inter-lab CV% of 50- 95% in the UK National External Quality Assessment Service (NEQAS), and is poorly sensitive meaning that urines need to be concentrated before measurement, sometimes up to 150-fold. Further, clinical manifestations such as proteinuria may obscure monoclonal FLC bands and makes identification and quantitation of monoclonal protein bands inaccurate. Therefore, we have developed a rapid test (Seralite®) that identifies abnormal FLC levels in unconcentrated urine or blood in 10 minutes. Seralite® quantitates κ and λ FLC levels simultaneously using highly specific anti-κ and anti-λ FLC monoclonal antibodies. Methods: Seralite® validation was conducted by retrospective analysis of urine from patients presenting with multiple myeloma (n=100). All samples were also measured for FLC by electrophoresis immunofixation; densitometry on concentrated urines; and a recently validated new Luminex assay that incorporates the same mAbs as Seralite®. Results: Seralite® displayed excellent clinical concordance with Luminex. Analysis of IFE results revealed that Seralite® had no false negatives, and correlated excellently with densitometry. Conclusion: Seralite® detected all FLC in urine from 100 myeloma patients at diagnosis. Prospective use of Seralite® to diagnose and monitor plasma cell dyscrasias including multiple myeloma should now be investigated. The utility of Seralite® in the context of other FLC related disorders including AL amyloidosis should also be established.

AB - Background. Monoclonal κ and λ immunoglobulin free light chains (FLC) in the urine are important biomarkers for the diagnosis and monitoring of a number of plasma cell dyscrasias including multiple myeloma. To date, laboratory FLC tests provide the only means of quantitating FLC and often have a slow turnaround time that prevents early diagnosis or prompt identification of changes in disease activity. Furthermore, the gold standards for identifying (immunofixation electrophoresis; IFE) and quantitating (densitometry) FLC in the urine have a number of limitations. IFE lacks analytical sensitivity (LOD >10-20 mg/L) and interpretation is often subjective. Densitometry has high inter-test variability that contributes to an inter-lab CV% of 50- 95% in the UK National External Quality Assessment Service (NEQAS), and is poorly sensitive meaning that urines need to be concentrated before measurement, sometimes up to 150-fold. Further, clinical manifestations such as proteinuria may obscure monoclonal FLC bands and makes identification and quantitation of monoclonal protein bands inaccurate. Therefore, we have developed a rapid test (Seralite®) that identifies abnormal FLC levels in unconcentrated urine or blood in 10 minutes. Seralite® quantitates κ and λ FLC levels simultaneously using highly specific anti-κ and anti-λ FLC monoclonal antibodies. Methods: Seralite® validation was conducted by retrospective analysis of urine from patients presenting with multiple myeloma (n=100). All samples were also measured for FLC by electrophoresis immunofixation; densitometry on concentrated urines; and a recently validated new Luminex assay that incorporates the same mAbs as Seralite®. Results: Seralite® displayed excellent clinical concordance with Luminex. Analysis of IFE results revealed that Seralite® had no false negatives, and correlated excellently with densitometry. Conclusion: Seralite® detected all FLC in urine from 100 myeloma patients at diagnosis. Prospective use of Seralite® to diagnose and monitor plasma cell dyscrasias including multiple myeloma should now be investigated. The utility of Seralite® in the context of other FLC related disorders including AL amyloidosis should also be established.

KW - immunoglobulin

KW - Bence Jones protein

KW - monoclonal antibody

KW - biological marker

KW - protein

KW - urinalysis

KW - light chain

KW - American

KW - clinical chemistry

KW - urine

KW - densitometry

KW - multiple myeloma

KW - diagnosis

KW - electrophoresis

KW - plasma cell dyscrasia

KW - human

KW - patient

KW - United Kingdom

KW - gold standard

KW - amyloidosis

KW - disease activity

KW - early diagnosis

KW - myeloma

KW - turnaround time

KW - monitoring

KW - laboratory

KW - blood

KW - rapid test

KW - proteinuria

KW - quality control

KW - assay

KW - diseases

M3 - Meeting abstract

VL - 60

SP - 6

JO - Clinical Chemistry

T2 - Clinical Chemistry

JF - Clinical Chemistry

SN - 0009-9147

IS - 10

ER -