Initial Screening Investigation

Freelite - Recommended for use at Diagnosis

Remove the inconvenience and ensure the best detection rate.

Optimise your detection rate of B cell dyscrasias by including Freelite in your laboratory algorithm. 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 (sIFE) can be ordered more selectively.1

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.
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."

Accuracy of different diagnostic approaches for monoclonal proteins

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
FLC alone 96 98 100 68**
SPE/CZE and FLC 99 98 100 68**
SPE/CZE, FLC 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

 

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.

 

Laboratory Diagnosis Algorithm

 

At diagnosis, urine tests are no longer necessary

 

Efficiency Gains

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

 

References

  1. Jerry A Katzmann, Robert A Kyle, Joanne Benson et al.

    Screening panels for detection of monoclonal gammopathies

    Clinical Chemistry August 2009; 55(8):1517-1522

    Reference: MKG535 Quantity:

  2. A Dispenzieri, R Kyle, G Merlini, JS Miguel, H Ludwig et al.
    "International Myeloma Working Group guidelines for serum-free light chain analysis in multiple myeloma and related disorders"
    Leukemia advance online publication 20 November 2008; doi:10.1038/leu.2008.307

    Reference: MKG492 Quantity:

  3. Mark Drayson, Liang X. Tang, Roger Drew, Graham P. Mead, Hugh Carr-Smith, and Arthur R. Bradwell.
    "Serum free light-chain measurements for identifying and monitoring patients with nonsecretory multiple myeloma"
    Blood 2001;97:9:2900-2902

    Reference: MKG183 Quantity:

  4. G. P. Mead, H. D. Carr-Smith, M. T. Drayson, G. J. Morgan, J. A. Child and A. R. Bradwell.
    "Serum free light chains for monitoring multiple myeloma"
    BJH 2004;126:348-354

    Reference: MKG228 Quantity:

  5. Arthur R Bradwell, Hugh D Carr-Smith, Graham P Mead, Timothy C Harvey, Mark T Drayson.
    "Serum test for assessment of patients with Bence Jones myeloma"
    Lancet 2003;361:489-491

    Reference: MKG189 Quantity:

  6. Helen J. Lachmann, Ruth Gallimore, Julian D. Gillmore, Hugh D. Carr-Smith, Arthur R. Bradwell, Mark B. Pepys and Philip N. Hawkins.
    "Outcome in systemic AL amyloidosis in relation to changes in concentration of circulating free immunoglobulin light chains following chemotherapy"
    BJH 2003;122:78-84

    Reference: MKG200 Quantity:

  7. Fleur Wolff, Claire Thiry and Dominique Willems

    "Assessment of the analytical performance and the sensitivity of serum free light chains immunoassay in patients with monoclonal gammopathy"

    Clin Bio 2007;40:351-354

  8. 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

  9. Peter G. Hill, Julia M. Forsyth, Baldeep Rai, and Stewart Mayne
    "Serum Free Light Chains: An Alternative Test to Urine Bence Jones Proteins When Screening for Monoclonal Gammopathies"
    Clin Chem 2006 52: 1743-1748.

    Reference: MKG326 Quantity:

  10. Jerry A. Katzmann, Angela Dispenzieri, Robert A. Kyle, Melissa R. Snyder, Matthew F. Plevak, Dirk R. Larson, Roshini S. Abraham, John A. Lust, L. Joseph Melton III, and S. Vincent Rajkumar.
    "Elimination of the Need for Urine Studies in the Screening Algorithm for Monoclonal Gammopathies by Using Serum Immunofixation and Free Light Chain Assays"
    Mayo Clin Proc. 2006;81(12):1575-1578

    Reference: MKG343 Quantity:

  11. EJD Robson, J Taylor, C Beardsmore et al

    Utility of serum free light chain analysis when screening for lymphoproliferative disorders

    LabMedicine June 2009;4(6):325-329 doi:10.1309/M6YUPSL3EIR7KE

    Reference: MKG523 Quantity: