Screening

Freelite® - Recommended for Use at Diagnosis

The combination of Freelite® and serum protein electrophoresis (SPE) enables sensitive quantification of serum free light chains for diagnosis. Therefore urine studies and serum immunofixation electrophoresis (sIFE) can be ordered more selectively.   

Freelite® is recommended in the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) and in the International Myeloma Working Group Guidelines.

The NCCN Guidelines® recommend the use of serum free light chain assays in the initial diagnostic workup of multiple myeloma and related disorders. "Use of free light chain (FLC) assay along with SPEP and sIFE yields high sensitivity while screening for MM and related plasma cell disorders."2

The International Myeloma Working Group guidelines state that Freelite® should be used for the diagnosis and monitoring of B cell dyscrasias. "In the context of screening for the presence of myeloma or related disorders, the serum FLC assay in combination with serum electrophoresis and immunofixation yield high sensitivity, and negates the need for 24-hr urine studies when screening for multiple myeloma."3

 

Suggested Laboratory Diagnosis Algorithm

An algorithm combining SPE and Freelite® FLC will allow for the most sensitive and specific identification of significant monoclonal proteins and negates the requirement for urine samples for screening for Bence Jones Protein.

 

 

 

 

 

Screening Panels for Detection of Monoclonal Gammopathies1

 

 

 

·         "...the use of serum PEL plus FLC provides a simple and efficient initial diagnostic screen for the high-tumour-burden monoclonal gammopathies such as MM, WM and SMM. Urine studies and serum IFE can be ordered more selectively." 1
·         "...most laboratories find it difficult to obtain both serum and urine samples from patients. In this hospital, despite publicity from the laboratory, concurrent urine samples are received from <40% of patients." 8
·         "...performing urine studies can become much more selective. This approach will not only reduce cost but also spare patients the inconvenience of a 24-hour urine collection" 9
·         "Urine tests are no longer necessary as part of the screening algorithm for identifying monoclonal gammopathies..." 9
·         "Critically, due to the poor compliance of urine sample provision, serum FLC analysis provided the most effective practical means of determining monoclonal FLC production in a diagnostic setting." 10

 

  1. Katzmann JA, et al. Screening panels for detection of monoclonal gammopathies. Clin Chem 2009; 55:1517-1522
  2. Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Multiple Myeloma V.1.2012. © 2011 National Comprehensive Cancer Network, Inc. All rights reserved.
  3. Dispenzieri A, et al. International Myeloma Working Group guidelines for serum-free light chain analysis in multiple myeloma and related disorders. Leukemia 2009; 23:215-224
  4. Lachmann HJ, et al. Outcome in systemic AL amyloidosis in relation to changes in concentration of circulating free immunoglobulin light chains following chemotherapy. Br J Haematol 2003; 122:78-85
  5. Abraham RS, et al. Correlation of Serum Immunoglobulin Free Light Chain Quantification with Urinary Bence Jones Protein in Light Chain Myeloma. Clin Chem 2002; 48:655-657
  6. Bradwell AR, et al. Serum test for assessment of patients with Bence Jones myeloma. Lancet 2003; 361:489-491
  7. Drayson M, et al. Serum free light-chain measurements for identifying and monitoring patients with nonsecretory multiple myeloma. Blood 2001; 97:2900-2902
  8. Hill PG, et al. Serum Free Light Chains: An Alternative Test to Urine Bence Jones Proteins When Screening for Monoclonal Gammopathies. Clin Chem 2006; 52:1743-1748
  9. Katzmann JA, et al. Elimination of the Need for Urine Studies in the Screening Algorithm for Monoclonal Gammopathies by Using Serum Immunofixation and Free Light Chain AssaysMayo Clin Proc 2006; 81:1575-1578
  10.  Robson EJD, et al. Utility of serum free light chain analysis when screening for lymphoproliferative disorders. LabMedicine 2009;4:325-329 doi:10.1309/M6YUPSL3EIR7KE