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Test ID: MPSU
Monoclonal Protein Study, Urine

Secondary ID A test code used for billing and in test definitions created prior to November 2011

8823

NY State Approved Indicates the status of NY State approval and if the test is orderable for NY State clients.

Yes

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

Monitoring patients with 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 IDReporting NameAvailable SeparatelyAlways Performed
PTUProtein, Total, UYesYes
PEUProtein Electrophoresis, UNoYes
IFXUImmunofixation, UNoYes

Testing Algorithm Delineates situation(s) when tests are added to the initial order. This includes reflex and additional tests.

The following algorithms are available in Special Instructions:

-Laboratory Approach to the Diagnosis of Amyloidosis

-Laboratory Screening Tests for Suspected Multiple Myeloma

Special Instructions and Forms Describes specimen collection and preparation information, test algorithms, and other information pertinent to test. Also includes pertinent information and consent forms to be used when requesting a particular test

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

PTU/8261: Dye Binding (Pyrogallol Red)

PEU/8244: Agarose Gel Electrophoresis

IFXU/82025: Immunofixation

Reporting Name A shorter/abbreviated version of the Published Name for a test; an abbreviated test name

Monoclonal Protein Study, 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

Specimen Type Describes the specimen type needed for testing

Urine

Specimen Required Defines the optimal specimen. This field describes the type of specimen required to perform the test and the preferred volume to complete testing. The volume allows automated processing, fastest throughput and, when indicated, repeat or reflex testing.

Container/Tube: Plastic, 60-mL urine bottle and plastic, 6-mL tube (Supply T465)

Specimen Volume: 50 mL

Collection Instructions:

1. Collect urine for 24 hours.

2. No preservative.

3. Label specimens appropriately (60-mL bottle for protein electrophoresis and immunofixation and 6-mL tube for protein, total).

Additional Information:

1. 24-Hour volume is required.

2. See Urine Preservatives in Special Instructions for multiple collections.

3. If a serum specimen on the same patient will also be submitted, order MPSS/81756 Monoclonal Protein Study, Serum under a separate order number.

 

Urine Preservative Collection Options

Ambient

Yes

Refrigerated

Preferred

Frozen

Yes

6N HCl

No

50% Acetic Acid

No

Na2CO3

No

Toluene

Yes

6N HNO3

No

Boric Acid

No

Thymol

Yes

Forms: If not ordering electronically, submit a General Request Form (Supply T239) with the specimen.

Specimen Minimum Volume Defines the amount of specimen required to perform an assay once, including instrument and container dead space. Submitting the minimum specimen volume makes it impossible to repeat the test or perform confirmatory or perform reflex testing. In some situations, a minimum specimen volume may result in a QNS (quantity not sufficient) result, requiring a second specimen to be collected.

25 mL

Reject Due To Identifies specimen types and conditions that may cause the specimen to be rejected

Hemolysis

NA

Lipemia

NA

Icterus

NA

Other

NA

Specimen Stability Information Provides a description of the temperatures required to transport a specimen to the laboratory. Alternate acceptable temperature(s) are also included.

Specimen TypeTemperatureTime
UrineRefrigerated (preferred)14 days
 Frozen 5 days
 Ambient 72 hours

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 in Special Instructions:

-Laboratory Approach to the Diagnosis of Amyloidosis                         

-Laboratory Screening Tests for Suspected Multiple Myeloma

 

Also see Diagnosis and Monitoring of Multiple Myeloma in Publications.

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

> or =18 years: <102 mg/24 hours

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

 

ELECTROPHORESIS, PROTEIN

If protein concentration is abnormal, the following fractions, if present, will be reported as a percent of the protein, total.

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 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 >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 hrs) 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 performed.

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 <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 Provides recommendations for further in-depth reading of a clinical nature

Kyle RA, Katzmann JA, Lust JA, Dispenzieri A: Clinical indications and applications of electrophoresis and immunofixation. In Manual of Clinical Laboratory Immunology. Sixth edition. Edited by NR Rose, et al. Washington, DC, ASM Press, 2002, pp 66-67 

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

Urine proteins are separated in an electric field according to their size, shape, and electric charge (Helena SPIFE 3000). The separation is performed on agarose gels (Helena SPIFE SPE Vis GEL). The proteins are visualized by staining with acid blue and the intensity of staining is quantitated by densitometry (Helena Quickscan 2000). Multiplying by the urine protein concentration (Pyrogallol Red) converts the percentage of protein in each fraction into urine concentration.(Kyle RA, Katzmann JA, Lust JA, Dispernzieri A: Immunochemical characterization of immunoglobulins. In Manual of Clinical Laboratory Immunology. Sixth edition. Edited by NR Rose, et al. Washington, DC, ASM Press, 2002, pp 71-91)

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

Protein, total: Monday through Sunday; Continuously

Electrophoresis, protein: Monday through Saturday; 12:00 p.m.

Immunofixation: Monday through Saturday; 8:00 a.m.

Analytic Time Defines the amount of time it takes the laboratory to setup and perform the test. This is defined in number of days. The shortest interval of time expressed is "same day/1 day," which means the results may be available the same day that the sample is received in the testing laboratory. One day means results are available 1 day after the sample is received in the laboratory.

Same day/1 day

Maximum Laboratory Time Defines the maximum time from specimen receipt at Mayo Medical Laboratories until the release of the test result

3 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 The location of the laboratory that performs the test

Rochester

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's instructions, or as products that do not undergo full FDA review and approval, and are then labeled as an Analyte Specific Reagent (ASR), Investigation Use Only (IUO) product, or a Research Use Only (RUO) product.

This test has been cleared or approved by the U.S. Food and Drug Administration and is used per manufacturer's instructions. Performance characteristics were verified by Mayo Clinic in a manner consistent with CLIA requirements.

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 Medical Laboratories interpretation of CPT coding requirements. It is the responsibility of each laboratory to determine correct CPT codes to use for billing.

84156-Protein, total

84166-Electrophoresis, protein

86335-Immunofixation

LOINC® Code Information Provides guidance in determining the Logical Observation Identifiers Names and Codes (LOINC) values for the result codes returned for this test or profile.

Result IDReporting NameLOINC Code
82025Immunofixation, U49277-7
2776Albumin17819-4
TP2Total Protein2889-4
TM23Collection Duration13362-9
2777Alpha 1-Globulin17811-1
2779Alpha 2-Globulin17813-7
VL21Urine Volume19153-6
CONC1Concentration35663-4
2780Beta-Globulin17815-2
2781Gamma-Globulin17817-8
2833A/G Ratio44293-9
21446M spike42482-0
22307M spike42482-0
21447Impression32210-7