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HelpTest Code SMPU Monoclonal Protein Screen, 24 Hour, Urine
Shipping Instructions
Refrigerate specimen during collection and send refrigerated.
Necessary Information
24-Hour volume (in milliliters) is required.
Specimen Required
Supplies: Urine Container, 60 mL (T313)
Submission Container/Tube: Plastic, 60-mL urine bottle
Specimen Volume: 50 mL
Collection Instructions:
1. Collect urine for 24 hours.
2. Aliquot between 30 mL and 50 mL of urine into a plastic, 60-mL urine bottle.
Additional Information: See Urine Preservatives-Collection and Transportation for 24-Hour Urine Specimens for multiple collections.
Secondary ID
616913Useful For
Monitoring patients with monoclonal gammopathies
Profile Information
| Test ID | Reporting Name | Available Separately | Always Performed |
|---|---|---|---|
| MPTU | M-protein Mass-Fix, 24 HR, U | No | Yes |
| PTU3 | Protein, Total, 24 HR, U | Yes | Yes |
Reflex Tests
| Test ID | Reporting Name | Available Separately | Always Performed |
|---|---|---|---|
| PEU | Protein Electrophoresis, 24 Hr, U | No | No |
Testing Algorithm
Testing for urine monoclonal proteins (M-proteins) with mass-fix alone is not considered adequate screening for monoclonal gammopathies.
The laboratory will evaluate the urine for M-proteins using the mass-fix method, and if positive for M-protein, protein electrophoresis will be performed at an additional charge.
The following algorithms are available:
Special Instructions
Method Name
PTU3: Turbidimetry
PEU: Agarose Gel Electrophoresis
MPTU: Matrix-Assisted Laser Desorption/Ionization Time-of-Flight Mass Spectrometry (MALDI-TOF MS)
Reporting Name
M-protein Screen, 24 HR, USpecimen Type
UrineSpecimen Minimum Volume
30 mL
Specimen Stability Information
| Specimen Type | Temperature | Time | Special Container |
|---|---|---|---|
| Urine | Refrigerated (preferred) | 14 days | |
| Frozen | 5 days | ||
| Ambient | 24 hours |
Reject Due To
All specimens will be evaluated at Mayo Clinic Laboratories for test suitability.Clinical Information
Urine proteins can be grouped into 5 fractions by protein electrophoresis:
-Albumin
-Alpha-1
-Alpha-2
-Beta-globulin
-Gamma-globulin
One or more quantifiable monoclonal proteins may be present and reported as M spike.
The urine total protein concentration, the electrophoretic pattern, and the presence of a monoclonal immunoglobulin light chain may be characteristic of monoclonal gammopathies such as multiple myeloma, primary systemic amyloidosis, and light chain deposition disease.
The following algorithms are available:
Reference Values
PROTEIN, TOTAL
<229 mg/24 hours
Reference values have not been established for patients younger than 18 years of age.
ELECTROPHORESIS, PROTEIN
The following fractions, if present, will be reported as mg/24 hours:
Albumin
Alpha-1-globulin
Alpha-2-globulin
Beta-globulin
Gamma-globulin
MASS-FIX M-PROTEIN ISOTYPE
M-protein Isotype MS:
No monoclonal protein detected
Flag M-protein Isotype MS:
Negative
Interpretation
The presence of a monoclonal immunoglobulin light chain in the urine is seen in multiple myeloma, macroglobulinemia, primary systemic amyloidosis and light-chain deposition disease, monoclonal gammopathy of undetermined significance, and idiopathic Bence-Jones proteinuria. The presence of a monoclonal light chain can produce renal insufficiency, may be deposited as amyloid fibrils, may damage the proximal tubes producing Fanconi syndrome, or light chains may deposit in the glomerulus and cause light-chain deposition disease.
Heavy-chain fragments as well as light chains may be seen in the urine of patients with multiple myeloma or amyloidosis.
Method Description
Protein:
The sample is preincubated in an alkaline solution containing EDTA, which denatures the protein and eliminates interference from magnesium ions. Benzethonium chloride is then added, producing turbidity.(Package insert: Total Protein Urine/CSF. Roche Diagnostics; V13.0, 11/2018)
Electrophoresis:
Urine proteins are separated in an electric field according to their size, shape, and electric charge (Helena SPIFE Touch). The separation is performed on agarose gels. The proteins are visualized by staining with acid blue and the intensity of staining is quantitated by densitometry (Helena Quick Scan Touch). Multiplying by the urine protein concentration converts the percentage of protein in each fraction into urine concentration.(Instruction manual: Helena SPIFE Touch. Helena Laboratories, Corp; 11/2016; package insert: Helena SPIFE Touch SPE Pro 277. Helena Laboratories, Corp; 06/2018; Keren DF, Humphrey RL: Clinical indications and applications of serum and urine protein electrophoresis. In: Detrick BD, Hamilton RG, Schmitz JL eds. Manual of Molecular and Clinical Laboratory Immunology. 8th ed. 2016:chap 8)
Mass-Fix:
Mass-Fix M-protein isotype by matrix-assisted laser desorption/ionization time-of-flight mass spectrometry (MALDI-TOF MS) is performed with immunoaffinity purification followed by MALDI-TOF MS analysis. For the immunoaffinity purification, patient sample is applied to 5 separate immunoaffinity resins (CaptureSelect, Life Sciences) specific to immunoglobulin G, A, M, K, and L. Unbound protein is washed away and the isolated immunoglobulins are reduced to separate the heavy and light chains subunits to be analyzed via MALDI-TOF MS. The 5 separate spectra from each patient immunopurification are overlaid and investigated for an overabundance of immunoglobulin and immunoglobulin light chain.(Milani P, Murray DL, Barnidge DR, et al: The utility of MASS-FIX to detect and monitor monoclonal proteins in the clinic. Am J Hematol. 2017 Aug;92(8):772-779. doi: 10.1002/ajh.24772)
Day(s) Performed
Monday through Friday
Performing Laboratory
Mayo Clinic Laboratories in Rochester
Test Classification
This test was developed and its performance characteristics determined by Mayo Clinic in a manner consistent with CLIA requirements. It has not been cleared or approved by the US Food and Drug Administration.CPT Code Information
84156
84166 Electrophoresis, protein (if appropriate)
0077U
LOINC Code Information
| Test ID | Test Order Name | Order LOINC Value |
|---|---|---|
| SMPU | M-protein Screen, 24 HR, U | In Process |
| Result ID | Test Result Name | Result LOINC Value |
|---|---|---|
| 617117 | M-protein Isotype MS, 24 HR, U | In Process |
| TP6 | Total Protein, 24 HR, U | 2889-4 |
| TM24 | Collection Duration | 13362-9 |
| 617118 | Flag M-protein Isotype MS, 24 HR, U | No LOINC Needed |
| VL92 | Urine Volume | 3167-4 |
Forms
If not ordering electronically, complete, print, and send a Renal Diagnostics Test Request (T830) with the specimen.