Test Catalog

Test Id : RSMPU

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Monoclonal Protein Screen, Random, Urine

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Overview

Test Catalog

Useful For
Suggests clinical disorders or settings where the test may be helpful

Identifying monoclonal gammopathies using random urine specimens

Profile Information
A profile is a group of laboratory tests that are ordered and performed together under a single Mayo Test ID. Profile information lists the test performed, inclusive of the test fee, when a profile is ordered and includes reporting names and individual availability.

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

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

  All specimens will be evaluated at Mayo Clinic Laboratories for test suitability.

Specimen Stability Information
Provides a description of the temperatures required to transport a specimen to the performing laboratory, alternate acceptable temperatures are also included

Specimen Type Temperature Time Special Container
Urine Refrigerated (preferred) 14 days
Frozen 5 days
Ambient 24 hours

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

Clinical Information
Discusses physiology, pathophysiology, and general clinical aspects, as they relate to a laboratory test

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

Day(s) Performed
Outlines the days the test is performed. This field reflects the day that the sample must be in the testing laboratory to begin the testing process and includes any specimen preparation and processing time before the test is performed. Some tests are listed as continuously performed, which means that assays are performed multiple times during the day.

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

Performing Laboratory Location
Indicates the location of the laboratory that performs the test

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.

CPT Code Information
Provides guidance in determining the appropriate Current Procedural Terminology (CPT) code(s) information for each test or profile. The listed CPT codes reflect Mayo Clinic Laboratories interpretation of CPT coding requirements. It is the responsibility of each laboratory to determine correct CPT codes to use for billing.

CPT codes are provided by the performing laboratory.

84156

82570

84166 Electrophoresis, protein (if appropriate)

0077U

LOINC® Information
Provides guidance in determining the Logical Observation Identifiers Names and Codes (LOINC) values for the order and results codes of this test. LOINC values are provided by the performing laboratory.

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

Test Setup Resources

Setup Files
Test setup information contains test file definition details to support order and result interfacing between Mayo Clinic Laboratories and your Laboratory Information System.

Excel | Pdf

Sample Reports
Normal and Abnormal sample reports are provided as references for report appearance.

Normal Reports | Abnormal Reports

SI Sample Reports
International System (SI) of Unit reports are provided for a limited number of tests. These reports are intended for international account use and are only available through MayoLINK accounts that have been defined to receive them.

SI Normal Reports | SI Abnormal Reports

Test Update Resources

Change Type Effective Date
New Test 2023-05-16