Startseite Medizin Evaluation of the N Latex free light chain assay in the diagnosis and monitoring of AL amyloidosis
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Evaluation of the N Latex free light chain assay in the diagnosis and monitoring of AL amyloidosis

  • Peter Mollee EMAIL logo , Jill Tate und Carel J. Pretorius
Veröffentlicht/Copyright: 10. August 2013
Clinical Chemistry and Laboratory Medicine (CCLM)
Aus der Zeitschrift Clinical Chemistry and Laboratory Medicine (CCLM) Band 51 Heft 12

Abstract

Background: We compared a novel assay for free light chain (FLC) quantitation based on monoclonal antibodies (N-Latex, Siemens, Germany) to the established polyclonal antibody-based assay (Freelite™, The Binding Site, UK) in AL amyloidosis.

Methods: Sixty-two diagnostic samples were analysed on a BNII nephelometer, 32 of which also had a post-treatment sample.

Results: In the diagnostic samples: for AL of κ type, the median involved FLC (iFLC) was significantly lower by the N-Latex assay (289 vs. 667 mg/L, p=0.0002) whereas for λ AL the values were similar (148 vs. 161 mg/L, p=0.84). Measurable disease, defined as a difference between involved and uninvolved FLC (dFLC) >50 mg/L was present in 82% by the N-Latex assay compared to 89% by the Freelite™ assay. For diagnostic sensitivity, the FLC ratio was normal in 21% (95% CI 12%–33%) and 15% (95% CI 7%–26%) of patients by the N-Latex and Freelite™ assays, respectively. The combination of serum and urine immunofixation electrophoresis with either FLC assay allowed identification of the amyloidogenic clone in 98% producing comparable sensitivity. For the monitoring samples the median reduction in dFLC was 68% for the N-Latex assay and 77% for the Freelite™ assay (p=0.04). This led to some differences in assigning response categories. Partial response as assigned by both assays predicted overall survival (N-Latex p=0.0015, Freelite™ p=0.022).

Conclusions: There are differences between FLC as measured by the N-Latex and Freelite™ assays, but overall the two assays have similar diagnostic sensitivity. Disease response calculated by both assays predicts survival but more clinical validation is required.

Keywords: AL amyloidosis; diagnosis; free light chain assay; monitoring
Corresponding author: Peter Mollee, Associate Professor, Department of Haematology, Pathology Queensland, Princess Alexandra Hospital, Ipswich Road, Woolloongabba, QLD 4102, Australia, Phone: +61 7 31762396, Fax: +61 7 31767042, E-mail:

We would like to acknowledge the Australasian Leukaemia and Lymphoma Group (ALLG) and the ALLG Tissue Bank for storing and supplying the serum samples associated with the ALLG MM8 study and the Princess Alexandra Hospital Amyloidosis Clinic.

Conflict of interest statement

Authors’ conflict of interest disclosure: The authors stated that there are no conflicts of interest regarding the publication of this article. Research funding played no role in the study design; in the collection, analysis, and interpretation of data; in the writing of the report; or in the decision to submit the report for publication.

Research funding: Siemens Healthcare supplied N Latex FLC kits free of charge for this study. JT and PM have also previously performed studies using Freelite™ kits provided free of charge from the Binding Site.

Employment or leadership: None declared.

Honorarium: None declared.

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Received: 2013-05-15
Accepted: 2013-07-14
Published Online: 2013-08-10
Published in Print: 2013-12-01

©2013 by Walter de Gruyter Berlin Boston

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https://doi.org/10.1515/cclm-2013-0361
Schlagwörter für diesen Artikel
AL amyloidosis; diagnosis; free light chain assay; monitoring

Artikel in diesem Heft

  1. Letters to the Editor
  2. The addition of MESNA in vitro prolongs prothrombin time similar to N-acetyl cysteine
  3. Detection of unknown β-thalassemia cases from atypical HbA1c chromatograms
  4. Analytical study of a new turbidimetric assay for urinary neutrophil gelatinase-associated lipocalin (NGAL) determination
  5. The rare bipolar-contracted red cell significance and correlation with red cell volume
  6. Howell-Jolly body interference in reticulocyte counts
  7. PBMC expressed adiponectin mRNA is predictive of survival in patients with gastric cancer
  8. Comparison study of two commercially available methods for the determination of infliximab, adalimumab, etanercept and anti-drug antibody levels
  9. Development and validation of a rapid and reliable high-performance liquid chromatography method for methadone quantification in human plasma and saliva
  10. Reply to Ruiz-Argüello et al.: Comparison study of two commercially available methods for the determination of infliximab, adalimumab, etanercept and anti-drug antibody levels
  11. Still more discussion on the journal impact factor
  12. The order of draw, myth or science
  13. Masthead
  14. Masthead
  15. Editorial
  16. Multidisciplinarity and interdisciplinarity at work: the prenatal diagnosis
  17. Research Articles
  18. Prenatal diagnosis of inherited diseases: 20 years’ experience of an Italian Regional Reference Centre
  19. Prenatal diagnosis of haemoglobinopathies: our experience of 523 cases
  20. Prenatal diagnosis of cystic fibrosis: an experience of 181 cases
  21. Prenatal diagnosis of haemophilia: our experience of 44 cases
  22. Prenatal molecular diagnosis of inherited neuromuscular diseases: Duchenne/Becker muscular dystrophy, myotonic dystrophy type 1 and spinal muscular atrophy
  23. Editorials
  24. Journal impact factor: the debate continues
  25. Estimation of uncertainty in measurements in the clinical laboratory
  26. Review
  27. Searching for genes involved in hypertension development in special populations: children and pre-eclamptic women. Where are we standing now?
  28. Opinion Paper
  29. More discussion on journal impact factor
  30. General Clinical Chemistry and Laboratory Medicine
  31. Category-specific uncertainty modeling in clinical laboratory measurement processes
  32. The order of draw: myth or science?
  33. Planned variation in preanalytical conditions to evaluate biospecimen stability in the National Children’s Study (NCS)
  34. Longitudinal evaluation of thyroid autoimmunity and function in pregnant Korean women
  35. Evaluation of the N Latex free light chain assay in the diagnosis and monitoring of AL amyloidosis
  36. Identification of an important potential confound in CSF AD studies: aliquot volume
  37. Cancer Diagnostics
  38. Double heterozygosity in the BRCA1 and BRCA2 genes in Italian family
  39. Quantification of EGFR autoantibodies in the amplification phenomenon of HER2 in breast cancer
  40. Diabetes
  41. SAA1 genetic polymorphisms are associated with plasma glucose concentration in non-diabetic subjects
  42. Acknowledgment
  43. Acknowledgment
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