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Freelite® - Recommended for use at Diagnosis

Remove the inconvenience and ensure the best detection rate

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.1  

Include Freelite® in your laboratory algorithm

International Guidelines recommend the use of Freelite®

The International Myeloma Working Group guidelines2 state that Freelite® should be used for the diagnosis, prognosis and monitoring of B cell dyscrasias.

The International Myeloma Working Group guidelines2 state that Freelite® should be used for the diagnosis, prognosis and monitoring of B cell dyscrasias. At diagnosis "The serum FLC assay in combination with serum PEL and serum IFE is sufficient to screen for pathological monoclonal plasmaproliferative disorders other than AL, which requires all the serum tests as well as the 24-h urine IFE."
The advice was based upon results obtained in extensive clinical trials using the polyclonal Freelite® assays.

Suggested laboratory diagnosis algorithm

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

A number of webinars are available with more information.

Using currently available data Table 1 shows the detection rate for all patients with Multiple Myeloma, AL amyloidosis, Light Chain Multiple Myeloma and Nonsecretory Multiple Myeloma using different combinations of diagnostic tests.3,4,5,6,7,8
It is important to note that for Light Chain Multiple Myeloma, Freelite® detected 100% of patients when compared to SPE and UPE which detected only 90%.
An optimal pick up rate for all paraproteins can be achieved by simply performing SPE or CZE plus Freelite® without the need for a urine sample.

Table 1

Protocols % of Paraproteins detected
  *Myeloma AL LCMM NSMM
SPE/CZE alone 90 50 40 - 57 0
SPE/CZE, serum IFE 95 70 75 0
SPE/CZE and UPE 95 75 90 0
SPE/CZE, UPE serum and urine IFE 97 90 95 0
Freelite® alone 96 98 100 68**

SPE/CZE and Freelite®

99 98 100 68**
SPE/CZE, Freelite® and serum IFE 99 98 100 68**
*Myeloma is inclusive of samples from patients identified with Intact Immunoglobulin Multiple Myeloma, Light Chain Multiple Myeloma and Nonsecretory Multiple Myeloma.
**A further 4/28 patients with suppression of one or both free light chains were identified in addition to this 68% equaling 82%.3

 

 

·         "...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." 9
·         "...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" 10
·         "Urine tests are no longer necessary as part of the screening algorithm for identifying monoclonal gammopathies..." 10
·         "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." 11

The above studies used Freelite® polyclonal serum free light chain assays.

In the clinic:
In the laboratory:
Just a simple blood collection
No need to chase for urine samples
No need to chase for urine samples
No requirement for storage of large volume samples
Improve the turnaround time for a patient result9
No time consuming concentration of urines
Reduce testing costs10
Maximise workflow through automation
Use the same reliable test in screening that you use in monitoring
Reduce hands on time and release valuable labour resource
Fully quantitative assay
Assay time of less than 20 minutes
No significant pathology missed by replacing urine Bence Jones Protein9
Improve the turnaround time for patient result9
 
Reduce testing costs10
 
Use the same reliable test in your initial evaluation that you use in monitoring

  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.1.2011. © 2010 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