Test Catalog

Test Id : RMPSU

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Monoclonal Protein Study, Random, Urine

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Overview

Test Catalog

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

Diagnosing monoclonal gammopathies

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
RPEU Protein Electrophoresis, Random, U No Yes
RIFXU Immunofixation, Random, U No Yes
PTCON Protein, Total, Random, U No Yes

Testing Algorithm
Delineates situations when tests are added to the initial order. This includes reflex and additional tests.

Special Instructions
Library of PDFs including pertinent information and forms related to the test

Method Name
A short description of the method used to perform the test

PTCON: Turbidimetry

RPEU: Agarose Gel Electrophoresis

RIFXU: Immunofixation

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

Monoclonal Protein Study, Random, U

Aliases
Lists additional common names for a test, as an aid in searching

Bence Jones Urine

Heavy Chains Urine

Immunoelectrophoresis, Urine

Immunofixation, Urine

Kappa Chains Urine

Lambda Chains Urine

Light Chains Urine

Paraprotein

Special Protein Studies, Urine

Immunofixation Electrophoresis (IFE)

Testing Algorithm
Delineates situations when tests are added to the initial order. This includes reflex and additional tests.

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 a monoclonal immunoglobulin, but a 24-hour specimen is preferred for quantitating and monitoring the abnormality. See MPSU / Monoclonal Protein Study, 24 Hour, Urine.

Shipping Instructions

Refrigerate specimen during 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)

-Sarstedt 5 mL Aliquot Tube (T914)

Submission Container/Tube: Plastic, 60-mL urine bottle and plastic, 5-mL tube

Specimen Volume: 50 mL

Collection Instructions:

1. Collect a random urine specimen.

2. Aliquot at least 25-mL of specimen into a plastic, 60-mL urine bottle and at least 1-mL of specimen into a plastic, 5-mL tube.

3. Label specimens appropriately (60-mL bottle for protein electrophoresis and 5-mL tube for protein, total).

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

25 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

Diagnosing monoclonal gammopathies

Testing Algorithm
Delineates situations when tests are added to the initial order. This includes reflex and additional tests.

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

-Alpha-2

-Beta-globulin

-Gamma globulin

 

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.

PROTEIN, TOTAL:

No reference values apply to random urine.

 

ELECTROPHORESIS, PROTEIN

The following fractions, if present, will be reported as mg/dL:

Albumin

Alpha-1 globulin

Alpha-2 globulin

Beta globulin

Gamma globulin

Interpretation
Provides information to assist in interpretation of the test results

A characteristic monoclonal band (M-spike) is often found in the urine of patients with monoclonal gammopathies. The initial identification of an M-spike or an area of restricted migration is followed by immunofixation to identify the immunoglobulin heavy chains and light chains.

 

Immunoglobulin free light chains as well as heavy chain fragments may be seen in the urine of patients with monoclonal gammopathies. The presence of a monoclonal light-chain M-spike of greater than 1 g/24 hours is consistent with a diagnosis of multiple myeloma or macroglobulinemia.

 

The presence of a small amount of monoclonal light chain and proteinuria (total protein >3 g/24 hours) that is predominantly albumin is consistent with primary systemic amyloidosis (AL) or light-chain deposition disease (LCDD).

 

Because patients with AL or LCDD may have elevated urinary protein without an identifiable M-spike, urine protein electrophoresis is not considered an adequate screen for these disorders and immunofixation is also recommended.

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 immunofixation.

 

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. Keren DF, Humphrey RL: Clinical indications and applications for serum and urine protein electrophoresis and immunofixation. In: Detrick B, Hamilton RG, Schmitz JL, eds. Molecular and Clinical Laboratory Immunology. 8th ed. Wiley; 2016:chap 8

Special Instructions
Library of PDFs including pertinent information and forms related to the test

Method Description
Describes how the test is performed and provides a method-specific reference

Electrophoresis:

Urine proteins are separated in an electric field according to their size, shape, and electric charge (Helena 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 (benzethonium chloride) 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 for serum and urine protein electrophoresis and immunofixation. In: Detrick B, Hamilton RG, Schmitz JL, eds. Molecular and Clinical Laboratory Immunology. 8th ed. Wiley; 2016:chap 8)

 

Immunofixation:

Urine proteins are separated in an electric field according to their size, shape, and electric charge. The separation is performed on agarose gels (Helena SPIFE Immunofix-15). The proteins are anchored in situ following electrophoresis. Antisera specific for gamma, alpha, mu, kappa, and lambda immunoglobulin heavy and light chains are applied to the gel forming insoluble complexes with any immunoglobulin present. The proteins are visualized by staining with acid violet.(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)

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.

Protein, total: Monday through Sunday

Electrophoresis, protein; Immunofixation: 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 Unit Codes

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 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.

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

84166

86335

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
RMPSU Monoclonal Protein Study, 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.
33044 A/G Ratio 44293-9
33045 M spike 40661-1
33046 M spike 40661-1
33047 Impression 49299-1
607975 Albumin 6942-7
607976 Alpha-1 globulin 9734-5
607977 Alpha-2 globulin 38190-5
607978 Beta globulin 9744-4
607979 Gamma globulin 9745-1
PTCON Protein, Total, Random, U 2888-6
32526 Immunofixation, Random, U 74666-9
606979 Immunofixation Flag, Random, U No LOINC Needed

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