Initial Investigation Protocol
Conventional laboratory analysis has involved serum protein electrophoresis (SPE) or capillary zone electrophoresis (CZE) plus urine protein electrophoresis (UPE) (for Light Chain Multiple Myeloma, Bence Jones Protein), followed by immunofixation electrophoresis (IFE).
Now, with Freelite, a more sensitive and specific protocol can be implemented to significantly increase detection of B cell dyscrasia.
In the initial laboratory investigation a strategy of performing serum protein electrophoresis and serum Freelite analysis will allow identification of all significant monoclonal proteins and negate the requirement for urine Bence Jones protein samples for screening.
Laboratory Investigation with Freelite
Requests for investigation of multiple myeloma require a serum sample. The sample should be analysed by both SPE and Freelite kappa and lambda assays, as proposed below:

Evidence for the Initial Investigation Protocol
In all recent studies the addition of serum Freelite assays to SPE as a first line test increased the detection of B cell dyscrasia.
A prospective analysis in a veterans population, published in Spring 2006 showed adoption of the Freelite plus SPEP protocol resulted in the additional detection of 15 Multiple Myeloma, 1 lymphoma and 1 patient with bladder transitional cell carcinoma.1
Further evidence from a prospective study of 1003 serum samples published in August 2005, indicated detection increased by 56% when Freelite assays were added to CZE.2
Shortly after that, (December 2005), Freelite assays were shown to be "...significantly more sensitive for detecting monoclonal FLC than urine IFE analysis".3
Using data from retrospective studies4-7, the table below shows the "pick up" rate for all Multiple Myeloma, AL amyloidosis, Light Chain Multiple Myeloma and Nonsecretory Multiple Myeloma using different combinations of screening tests.
It can be seen that the optimal pick up rate for all paraproteins can be achieved using simply SPE or CZE and Freelite.
This screening strategy replaces the need for urine testing for Bence Jones proteins
| Protocols | % of Paraproteins detected | |||
|---|---|---|---|---|
| *Myeloma | AL | LCMM | NSMM | |
| SPE/CZE alone | 90 | 50 | 45 | 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%.7 |
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- Download Literature - Eliminating urine testing during initial investigations for monoclonal gammopathies Code MKG369
- Download Literature - Laboratory Diagnosis Code MKG243.1E
Replacement of urine tests for Bence Jones protein
Two recently published studies indicate clearly that if you replace urine Bence Jones Protein tests with serum assays including Freelite free light chains, during the initial investigation for Multiple Myeloma, all patients requiring medical intervention are identified.
"Urine tests are no longer necessary as part of the screening algorithm for identifying monoclonal gammopathies..."8
"..no significant pathology would have been missed by replacing BJP with serum FLCs."9
In a screening study of 923 serum samples seven patients with monoclonal gammopathy and one patient with malignant lymphoma were detected by the presence of an abnormal kappa/lambda ratio among 43 patients who were negative by SPE.9 Importantly, this study also analysed 370 urine samples and the results were compared to corresponding serum FLC results for those patients.

The serum FLC test showed much higher specificity than urine protein electrophoresis. All significant pathology was detected by a combination of serum electrophoresis and serum FLC.9
- Download Literature - Are you still testing urine for Bence Jones protein? Code MKG357
- Download FRENCH Literature - Pourquoi testez-vous encore les urines? Code MKG394
Benefits of Freelite
- Freelite eliminates the requirement for urine samples for Bence Jones protein.
- Freelite provides quantitative, precise results from a single serum sample.
- Freelite has an assay time of less than 20 minutes.
- Freelite can provide sensitive analysis of free light chains giving additional diagnostic information for multiple myeloma patients.
- Freelite aids compliance to guidelines.
International One Day Conference, September 10th 2004
Applications of serum free light chain tests in Haematology
The latest data on diagnosis and monitoring with Freelite was presented to over 150 haematologists, biochemists and immunologists who attended the third UK symposium on applications of free light chain assays.
Eminent speakers included Professor Robert Kyle and Professor Philip Greipp from the Mayo Clinic, USA, Professor Michel Attal, Hôpital de Toulouse, France and Dr Helen Lachmann, UK National Amyloid Reference Centre, Royal Free Hospital, London.
The final session was a Summary and Discussion of a Free Light Chain Consensus Statement. The panel was Robert Kyle, Michel Attal, Philip Greipp, Helen Lachman and Jo Bradwell.
Consensus Statement - Application of Serum Free Light Chain Testing
The following summarises the consensus view for laboratory application of serum free light chain immunoassays in comparison to other methods:
| Test Procedures | For Diagnosis | For Monitoring |
|---|---|---|
| SPE/CZE | Inadequate/Good | Inadequate/Good |
| SPE/CZE + IFE + UPE | Good/Best Practice | Good/Best Practice |
| SPE/CZE + Freelite* | Best Practice | Best Practice |
|
Choice of statements - Best practice, Good, Indequate
*Urine testing is important in occasional patients |
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Feedback from delegates highlighted that:
- All delegates were proposing to evaluate their current practice in the light of the evidence presented.
- 74% of delegates were actively planning to modify their approach to diagnosis and monitoring of myeloma patients.

