Useful For
Suggests clinical disorders or settings where the test may be helpful
Identifying monoclonal gammopathies using random urine specimens
Test Id |
Reporting Name |
Available Separately |
Always Performed |
MPTRU |
M-protein Mass-Fix, Random, U |
No
|
Yes |
RPTU2 |
Protein/Creatinine Ratio, Random, U |
Yes, (RPTU1)
|
Yes |
Reflex Tests
Lists tests that may or may not be performed, at an additional charge, depending on the result and interpretation of the initial tests.
Test Id |
Reporting Name |
Available Separately |
Always Performed |
RPEU |
Protein Electrophoresis, Random, U |
No
|
No |
Testing Algorithm
Delineates situations when tests are added to the initial order. This includes reflex and additional tests.
Urine M-protein mass-fix alone is not considered adequate screening for monoclonal gammopathies.
The laboratory will evaluate the urine for M-proteins with the mass-fix method, and if positive for M-protein, protein electrophoresis will be performed at an additional charge.
The following algorithms are available:
-Amyloidosis: Laboratory Approach to Diagnosis
-Multiple Myeloma: Laboratory Screening
Method Name
A short description of the method used to perform the test
RPTU2: Turbidimetry/Enzymatic Colorimetric Assay
RPEU: Agarose Gel Electrophoresis
MPTRU: Matrix-Assisted Laser Desorption/Ionization Time-of-Flight Mass Spectrometry (MALDI-TOF MS)
NY State Available
Indicates the status of NY State approval and if the test is orderable for NY State clients.
Yes
Reporting Name
Lists a shorter or abbreviated version of the Published Name for a test
M-protein Screen, Random, U
Aliases
Lists additional common names for a test, as an aid in searching
Bence Jones Urine
Heavy Chains Urine
Immunoelectrophoresis, Urine
Immunofixation Electrophoresis (IFE)
Immunofixation, Urine
Kappa Chains Urine
Lambda Chains Urine
Light Chains Urine
Paraprotein
Special Protein Studies, Urine
Mass-Fix
Mass Fix
MassFix
Protein Electrophoresis
Urine Protein Electrophoresis
Testing Algorithm
Delineates situations when tests are added to the initial order. This includes reflex and additional tests.
Urine M-protein mass-fix alone is not considered adequate screening for monoclonal gammopathies.
The laboratory will evaluate the urine for M-proteins with the mass-fix method, and if positive for M-protein, protein electrophoresis will be performed at an additional charge.
The following algorithms are available:
-Amyloidosis: Laboratory Approach to Diagnosis
-Multiple Myeloma: Laboratory Screening
Specimen Type
Describes the specimen type validated for testing
Urine
Ordering Guidance
The use of a random urine specimen is sufficient for identifying the presence or absence of monoclonal proteins, but a 24-hour specimen is preferred for quantitating and monitoring the abnormality. See SMPU / Monoclonal Protein Screen, 24 Hour, Urine.
Shipping Instructions
Refrigerate specimen after collection and send refrigerated.
Specimen Required
Defines the optimal specimen required to perform the test and the preferred volume to complete testing
Supplies: Urine Container, 60 mL (T313)
Submission Container/Tube: Plastic, 60-mL urine bottle
Specimen Volume: 50 mL
Collection Instructions:
1. Collect random urine specimen.
2. Aliquot between 30 mL and 50 mL of urine into a plastic, 60 mL urine bottle.
Special Instructions
Library of PDFs including pertinent information and forms related to the test
Forms
If not ordering electronically, complete, print, and send a Renal Diagnostics Test Request (T830) with the specimen.
Specimen Minimum Volume
Defines the amount of sample necessary to provide a clinically relevant result as determined by the testing laboratory. The minimum volume is sufficient for one attempt at testing.
30 mL
Reject Due To
Identifies specimen types and conditions that may cause the specimen to be rejected
Thawing Cold OK; Warm OK
All specimens will be evaluated at Mayo Clinic Laboratories for test suitability.
Specimen Type |
Temperature |
Time |
Special Container |
Urine |
Ambient |
24 hours |
|
|
Refrigerated (preferred) |
14 days |
|
|
Frozen |
5 days |
|
Useful For
Suggests clinical disorders or settings where the test may be helpful
Identifying monoclonal gammopathies using random urine specimens
Testing Algorithm
Delineates situations when tests are added to the initial order. This includes reflex and additional tests.
Urine M-protein mass-fix alone is not considered adequate screening for monoclonal gammopathies.
The laboratory will evaluate the urine for M-proteins with the mass-fix method, and if positive for M-protein, protein electrophoresis will be performed at an additional charge.
The following algorithms are available:
-Amyloidosis: Laboratory Approach to Diagnosis
-Multiple Myeloma: Laboratory Screening
Urine proteins can be grouped into 5 fractions by protein electrophoresis:
-Albumin
-Alpha-1-globulin
-Alpha-2-globulin
-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:
-Amyloidosis: Laboratory Approach to Diagnosis
-Multiple Myeloma: Laboratory Screening
Reference Values
Describes reference intervals and additional information for interpretation of test results. May include intervals based on age and sex when appropriate. Intervals are Mayo-derived, unless otherwise designated. If an interpretive report is provided, the reference value field will state this.
CREATININE:
> or =18 years old: 16-326 mg/dL
Reference values have not been established for patients younger than 18 years of age.
PROTEIN/CREATININE RATIO:
> or =18 years: <0.18 mg/mg creatinine
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/dL:
-Albumin
-Alpha-1-globulin
-Alpha-2-globulin
-Beta-globulin
-Gamma-globulin
No reference values apply to random urines.
MASS-FIX M-PROTEIN ISOTYPE
M-protein Isotype MS:
No monoclonal protein detected
Flag M-protein Isotype MS:
Negative
Interpretation
Provides information to assist in interpretation of the test results
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.
Cautions
Discusses conditions that may cause diagnostic confusion, including improper specimen collection and handling, inappropriate test selection, and interfering substances
Monoclonal gammopathies are rarely seen in patients younger than 30 years of age.
Hemolysis may cause a discrete band on protein electrophoresis, which will be negative on isotyping.
Penicillin may split the albumin band.
Radiographic agents may produce an uninterpretable pattern.
Clinical Reference
Recommendations for in-depth reading of a clinical nature
1. Abraham RS, Barnidge DR: Protein analysis in the clinical immunology laboratory. In: Detrick B, Hamilton RG, Schmitz JL, eds. Molecular and Clinical Laboratory Immunology. 8th ed. Wiley; 2016:chap 4
2. Sykes E, Posey Y: Immunochemical characterization of immunoglobulins in serum, urine, and cerebrospinal fluid. In: Detrick B, Hamilton RG, Schmitz JL, eds. Molecular and Clinical Laboratory Immunology. 8th ed. Wiley; 2016:chap 9
Method Description
Describes how the test is performed and provides a method-specific reference
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)
Creatinine:
The enzymatic method is based on the determination of sarcosine from creatinine with the aid of creatininase, creatinase, and sarcosine oxidase. The liberated hydrogen peroxide is measured via a modified Trinder reaction using a colorimetric indicator. Optimization of the buffer system and the colorimetric indicator enables the creatinine concentration to be quantified both precisely and specifically.(Package insert: Creatinine plus v2. Roche Diagnostics; V15.0, 03/2019)
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 serum 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)
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)
PDF Report
Indicates whether the report includes an additional document with charts, images or other enriched information
No
Monday through Friday
Report Available
The interval of time (receipt of sample at Mayo Clinic Laboratories to results available) taking into account standard setup days and weekends. The first day is the time that it typically takes for a result to be available. The last day is the time it might take, accounting for any necessary repeated testing.
4 to 6 days
Specimen Retention Time
Outlines the length of time after testing that a specimen is kept in the laboratory before it is discarded
See Individual Test IDs
Rochester
Fees :
Several factors determine the fee charged to perform a test. Contact your U.S. or International Regional Manager for information about establishing a fee schedule or to learn more about resources to optimize test selection.
- Authorized users can sign in to Test Prices for detailed fee information.
- Clients without access to Test Prices can contact Customer Service 24 hours a day, seven days a week.
- Prospective clients should contact their account representative. For assistance, contact Customer Service.
Test Classification
Provides information regarding the medical device classification for laboratory test kits and reagents. Tests may be classified as cleared or approved by the US Food and Drug Administration (FDA) and used per manufacturer instructions, or as products that do not undergo full FDA review and approval, and are then labeled as an Analyte Specific Reagent (ASR) product.
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.
84156
82570
84166 Electrophoresis, protein (if appropriate)
0077U
Test Id |
Test Order Name |
Order LOINC Value
|
RSMPU |
M-protein Screen, Random, U |
In Process |
Result Id |
Test Result Name |
Result LOINC Value
Applies only to results expressed in units of measure originally reported by the performing laboratory. These values do not apply to results that are converted to other units of measure.
|
617119 |
M-protein Isotype MS, Random, U |
In Process |
617120 |
Flag M-protein Isotype MS, Random, U |
No LOINC Needed |
CRTR1 |
Creatinine, Random, U |
2161-8 |
PCRT1 |
Protein/Creatinine Ratio |
2890-2 |
PTCN1 |
Protein, Total, Random, U |
2888-6 |