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HelpTest Code SOFT: Z1000 Immunoglobulin Total Light Chains, Urine
Additional Codes
| Ordering Mnemonic | Mayo Test ID |
|---|---|
| HOM: MISC LAB | TLCU |
Reporting Name
Immunoglobulin Total Light Chains,UUseful For
Monitoring patients whose urine demonstrates large M-spikes
Confirming the quantitation of specimens that show M-spikes by electrophoresis
Detecting urine monoclonal proteins and identification of specimens that need urine protein electrophoresis
Profile Information
| Test ID | Reporting Name | Available Separately | Always Performed |
|---|---|---|---|
| KTLCU | Kappa Total Light Chain, U | No | Yes |
| LTLCU | Lambda Total Light Chain, U | No | Yes |
| KLTRU | Kappa/Lambda TLC Ratio, U | No | Yes |
Method Name
KTLCU, LTLCU: Nephelometry
Performing Laboratory
Mayo Clinic Laboratories in Rochester
Specimen Type
UrineOrdering Guidance
If serum is being submitted on the same patient for FLCS / Immunoglobulin Free Light Chains, Serum; that test should be ordered under a different order number.
Specimen Required
Submit only 1 of the following specimens:
Supplies:Â Sarstedt Aliquot Tube, 5 mL (T914)
Specimen Type: Random urine
Collection Container/Tube: Clean, plastic urine collection container
Submission Container/Tube: Plastic, 5-mL tube
Specimen Volume: 1 mL
Collection Instructions:
1. Collect a random urine specimen.
2. Refrigerate after collection and send refrigerate.
Specimen Type: 24-Hour urine
Container/Tube: Plastic, 5-mL tube
Specimen Volume: 1 mL
Collection Instructions:
1. Collect urine for 24 hours.
2. No additive needed for preservation.
3. Urine may be kept ambient during the collection period but should be refrigerated within 4 hours of collection completion.
Additional Information: See Urine Preservatives-Collection and Transportation for 24-Hour Urine Specimens for multiple collections.
Specimen Minimum Volume
0.5 mL
Specimen Stability Information
| Specimen Type | Temperature | Time | Special Container |
|---|---|---|---|
| Urine | Refrigerated (preferred) | 7 days | |
| Frozen | 20 days | ||
| Ambient | 72 hours |
Reject Due To
All specimens will be evaluated at Mayo Clinic Laboratories for test suitability.Special Instructions
Reference Values
KAPPA TOTAL LIGHT CHAIN
<0.9 mg/dL
LAMBDA TOTAL LIGHT CHAIN
<0.7 mg/dL
KAPPA/LAMBDA RATIO
0.7-6.2
Day(s) Performed
Monday through Friday
CPT Code Information
83883 x 2
LOINC Code Information
| Test ID | Test Order Name | Order LOINC Value |
|---|---|---|
| TLCU | Immunoglobulin Total Light Chains,U | 44792-0 |
| Result ID | Test Result Name | Result LOINC Value |
|---|---|---|
| KLTRU | Kappa/Lambda TLC Ratio, U | 33559-6 |
| KTLCU | Kappa Total Light Chain, U | 27365-6 |
| LTLCU | Lambda Total Light Chain, U | 27394-6 |
Test Classification
This test has been modified from the manufacturer's instructions. Its performance characteristics were determined by Mayo Clinic in a manner consistent with CLIA requirements. This test has not been cleared or approved by the US Food and Drug Administration.Clinical Information
Immunoglobulin light chains are usually cleared from blood through the renal glomeruli and reabsorbed in the proximal tubules so that urine light-chain concentrations are very low or undetectable. The production of large amounts of monoclonal light chains, however, can overwhelm this reabsorption mechanism. The detection of monoclonal light chains in the urine (Bence Jones proteinuria) has been used as a diagnostic marker for multiple myeloma since the report by Dr. H. Bence Jones in 1847.
Current laboratory procedures employ protein electrophoresis and isotype testing for the identification and characterization of urine monoclonal light chains, which may be present in large enough amounts to also be quantified as an M-spike on protein electrophoresis. The electrophoretic M-spike is the recommended method of monitoring monoclonal gammopathies, such as multiple myeloma. Monitoring the urine M-spike is especially useful in patients with light-chain multiple myeloma in whom the serum M-spike is very small or absent, but the urine M-spike is large.
Just as quantitative serum immunoglobulins by immunonephelometry are a complement to M-spike quantitation by serum electrophoresis, this quantitative urine light-chain assay may be used to complement urine M-spike quantitation by electrophoresis.
Interpretation
A kappa/lambda (K/L) ratio greater than 6.2 suggests the presence of monoclonal kappa light chains.
A K/L ratio less than 0.7 suggests the presence of monoclonal lambda light chains.
In 24-hour specimens, a greater than 90% increase in concentration suggests progression or relapse; a greater than 90% decrease suggests treatment response.
Increased kappa and/or lambda light chains may be seen in benign (polyclonal) and neoplastic (monoclonal) disorders.
Cautions
Unlike the electrophoretic M-spike, this immunoassay quantitates both polyclonal and monoclonal light chains and is therefore not sensitive for detecting small monoclonal abnormalities. A normal kappa/lambda (K/L) ratio does not rule out a monoclonal protein, and an abnormal ratio does not identify a monoclonal protein. Urine protein electrophoresis and isotype testing are more sensitive and specific.
The quantitation of urine kappa light chain by immunonephelometry yields results that are approximately 2 times the values from the electrophoresis M-spike. Sequential results should be compared to previous results obtained by the same methodology.
Supportive Data
In a study of 168 urine samples with a monoclonal light chain detected by immunofixation electrophoresis (IFE), there were 20 samples with a normal kappa/lambda (K/L) ratio. These samples had either no M-spike (n=13) or M-spikes <0.5 mg/dL. Conversely, among the 148 cases with an abnormal K/L ratio, there were 12 samples with no M-spike indicating that there is no clear M-spike value at which the K/L ratio identifies monoclonal light chains. In patients with an M-spike, the relationship between the kappa and lambda light-chain quantitation and the size of the M-spike had good correlation (kappa, r[2]=0.94;lambda,r[2]=0.71) and the regression lines had slopes of 2.4 of kappa and 1.1 for lambda.
Interestingly, there was a single case in which the K/L ratio was 24 and the free light-chain K/L ratio was 58, but the IFE showed polyclonal light chains. The patient was post-transplant for a kappa light-chain multiple myeloma and presumably had multiple forms of a monoclonal kappa light chain that migrated in a smear and was a false-negative by IFE.
Clinical Reference
1. Kumar S, Paiva B, Anderson KC, et al: International Myeloma Working Group consensus criteria for response and minimal residual disease assessment in multiple myeloma. Lancet Oncol. 2016 Aug;17(8):e328-e346
2. Leung N, Barnidge DR, Hutchison CA: Laboratory testing in monoclonal gammopathy of renal significance (MGRS). Clin Chem Lab Med. 2016 Jun 1;54(6):929-937
3. Willrich MA, Katzmann JA: Laboratory testing requirements for diagnosis and follow-up of multiple myeloma and related plasma cell dyscrasias. Clin Chem Lab Med. 2016 Jun 1;54(6):907-919
4. Rajkumar SV, Kyle RA: Multiple myeloma: diagnosis and treatment. Mayo Clin Proc. 2005 Oct;80(10):1371-1382
Method Description
In this Siemens Nephelometer II method, the light scattered onto the antigen-antibody complexes is measured. The intensity of the measured scattered light is proportional to the amount of antigen-antibody complexes in the sample under certain conditions. If the antibody volume is kept constant, the signal behaves proportionally to the antigen volume.
A reference curve is generated by a standard with a known antigen content on which the scattered light signals of the samples can be evaluated and calculated as an antigen concentration. Antigen-antibody complexes are formed when a sample containing antigen and the corresponding antiserum are put into a cuvette. A light beam is generated with an LED, which is transmitted through the cuvette. The light is scattered onto the immuno-complexes that are present. Antigen and antibody are mixed in the initial measurement, but no complex is yet formed. An antigen-antibody complex is formed in the final measurement.
The result is calculated by subtracting value of the final measurement from the initial measurement. The distribution of intensity of the scattered light depends on the ratio of the particle size of the antigen-antibody complexes to the radiated wavelength.(Instruction manual: Siemens Nephelometer II. Siemens, Inc; Version 2.3, 2008; Addendum to the Instruction Manual 2.3, 08/2017)