Test Catalog

Test Id : MPSU

Monoclonal Protein Study, 24 Hour, Urine

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

Monitoring patients with monoclonal gammopathies using 24-hour 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
PTU Protein, Total, 24 HR, U Yes Yes
PEU Protein Electrophoresis, 24 Hr, U No Yes
IFXU Immunofixation, 24 Hr, 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

PTU: Turbidimetry

PEU: Agarose Gel Electrophoresis

IFXU: 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, 24 Hr, 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

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

Shipping Instructions

Refrigerate specimen during collection and send refrigerated.

Necessary Information

24-Hour volume is required.

ORDER QUESTIONS AND ANSWERS

Question ID Description Answers
TM23 Collection Duration
VL21 Urine Volume

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 urine for 24 hours.

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

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

Additional Information: See Urine Preservatives-Collection and Transportation for 24-Hour Urine Specimens for multiple collections.

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.

Urine Preservative Collection Options

Note: The addition of preservative or application of temperature controls must occur within 4 hours of completion of the collection.

Ambient

OK

Refrigerate

Preferred

Frozen

OK

50% Acetic Acid

No

Boric Acid

No

Diazolidinyl Urea

OK

6M Hydrochloric Acid

No

6M Nitric Acid

No

Sodium Carbonate

No

Thymol

OK

Toluene

No

 

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

Monitoring patients with monoclonal gammopathies using 24-hour urine specimens

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

<229 mg/24 hours

Reference values have not been established for patients <18 years of age.

Reference value applies to 24-hour collection.

 

ELECTROPHORESIS, PROTEIN

The following fractions, if present, will be reported as mg/24 hours:

Albumin

Alpha-1 globulin

Alpha-2 globulin

Betaglobulin

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 chain and/or light chain.

 

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. Kyle RA, Katzmann JA, Lust JA, Dispenzieri A: Clinical indications and applications of electrophoresis and immunofixation. In: Rose NR, Hamilton RG, Detrick B, eds. Manual of Clinical Laboratory Immunology. 6th ed. ASM Press; 2002:71-91

2. 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

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; Abraham RS, Barnidge DR: Protein analysis in the clinical immunology laboratory. In: Detrick BD, Hamilton RG, Schmitz JL eds. Manual of Molecular and Clinical Laboratory Immunology. 8th ed. 2016:chap 4)

 

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.(Abraham RS, Barnidge DR: Protein analysis in the clinical immunology laboratory. In: Detrick BD, Hamilton RG, Schmitz JL eds. Manual of Molecular and Clinical Laboratory Immunology. 8th ed. 2016:chap 4)

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 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 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
MPSU Monoclonal Protein Study, 24 Hr, 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.
82025 Immunofixation, 24 Hr, U 33042-3
606980 Immunofixation Flag, 24 Hr, U No LOINC Needed
2833 A/G Ratio 44294-7
21446 M spike 42482-0
22307 M spike 42482-0
21447 Impression 32210-7
607970 Albumin 6941-9
607971 Alpha-1 globulin 6794-2
607972 Alpha-2 globulin 6795-9
607973 Beta globulin 94714-3
607974 Gamma globulin 94715-0
TP2 Total Protein, 24 HR, U 2889-4
TM23 Collection Duration 13362-9
VL21 Urine Volume 19153-6
CONC1 Total Protein Concentration 21482-5

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
File Definition - Result ID 2021-04-29