Initial Screening Investigation
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 MKG242.2E
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.
For Screening, urine tests are no longer necessary
- "Discontinuation of urine studies and reliance on a diagnostic algorithm using only serum studies (protein electrophoresis, immunofixation and free light chain quantitation) missed 2 (0.5%) of the 428 monoclonal gammopathies with urinary monoclonal proteins, and these 2 cases required no medical intervention."8
- "...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"8
- "With the addition of serum FLC to serum PE and IFE, including urine tests in diagnostic screening algorithms is no longer necessary"8
- Additional diagnostic information is gained by adding serum FLC's to SPEP as first-line tests for investigating possible B-cell disorders. The quality of the diagnostic service is enhanced by more confident exclusion of light chain disorders and improved interpretive assessment of SPEP and immunofixation electrophoresis.9
- "Urine tests are no longer necessary as part of the screening algorithm for identifying monoclonal gammopathies,..."8
- "...we have now adopted SPEP and serum FLCs as our first-line tests for the investigation of possible B-cell disorders."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
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 costs8 | 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 costs8 | |
| Use the same reliable test in your initial evaluation that you use in monitoring |

