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Test ID: REPU
Electrophoresis, Protein, Random, Urine

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

Identifying patients with a monoclonal M-spike

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
RPEUProtein Electrophoresis, Random, UNoYes
PTCONProtein, Total, Random, UNoYes

Reflex Tests Lists test(s) that may or may not be performed, at an additional charge, depending on the result and interpretation of the initial test(s)

Test IDReporting NameAvailable SeparatelyAlways Performed
RIFXUImmunofixation, Random, UNoNo

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

If a discrete electrophoresis band is identified, the laboratory will evaluate the urine protein electrophoresis and, if necessary, perform immunofixation at an additional charge.

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

PTCON/M85681: Dye Binding (Pyrogallol Red)

RPEU/32525: Agarose Gel Electrophoresis

RIFXU/32526: Immunofixation

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

Electrophoresis, Protein, Random, U

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

Gamma-Globulin
Immunology Profile (Pr Elect)
Macroglobulins
Protein Elect+Immunofixation (ALWAYS ORDER 82441)
Protein Electrophoresis+Total Protein
SPE (Serum Protein Electrophoresis)
SPEP (Serum Protein Electrophoresis)

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.

Collection Container/Tube: Clean, plastic urine collection container

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

Specimen Volume: 50 mL

Collection Instructions:

1. Collect a random urine specimen.

2. No preservative.

3. Divide specimen between submission containers.

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

Additional Information:

1. Random urine, no volume is required.

2. If a serum specimen on the same patient will also be submitted, order PEL/80085 Electrophoresis, Protein, Serum under a separate order number.

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.

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.

ELECTROPHORESIS, PROTEIN

The following fractions, if present, will be reported as a percent of the total protein. 

Albumin

Alpha-1-globulin

Alpha-2-globulin

Beta-globulin

Gamma-globulin 

No reference values apply to random urines.

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 multiple myeloma (MM). The initial identification of an M-spike or an area of restricted migration should be followed by MPSU/8823 Monoclonal Protein Study, Urine, which includes immunofixation electrophoresis to identify the immunoglobulin heavy chain and/or light chain. Immunoglobulin heavy chain fragments as well as free light chains 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 MM 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) and light-chain deposition disease (LCDD). Because patients with AL and LCDD may have elevated urinary protein without an identifiable M-spike, urine protein electrophoresis is not considered an adequate screen for the disorder. MPSU/8823 Monoclonal Protein Study, Urine, which includes immunofixation electrophoresis, should be performed if the clinical suspicion is high.

Cautions Discusses conditions that may cause diagnostic confusion, including improper specimen collection and handling, inappropriate test selection, and interfering substances

Urine protein electrophoresis (PEL) alone is not considered adequate screening for monoclonal gammopathies. Patients suspected of having a monoclonal gammopathy may have a normal urine protein electrophoretic pattern, and these patients should have immunofixation electrophoresis (MPSU/8823 Monoclonal Protein Study, Urine) performed.

 

Random urine specimens may be sufficient for identifying monoclonal proteins, but 24 hour specimens should be used to quantitate and monitor urinary abnormalities.

 

Monoclonal gammopathies are rarely seen in patients <30 years of age.

 

Hemolysis may cause a discrete band on PEL, 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

1. Kyle RA, Katzmann JA, Lust JA, Dispenziei A: Clinical indications and applications of electrophoresis and immunofixation. In Manual of Clinical Laboratory Immunology. 6th edition. Edited by NR Rose, et al. Washington, DC. ASM Press, 2002, pp 66-67

2. Kyle RA, Katzmann JA, Lust JA, Dispernzieri A: Immunochemical characterization of immunoglobulins. In Manual of Clinical Laboratory Immunology. 6th  edition. Edited by N.R. Rose, et al. 6th edition. Washington, DC. ASM Press, 2002, pp 71-91

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 Quick Scan 2000). Multiplying by the urine protein concentration (Coomasie blue) 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. 6th 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; Continuous

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

2 days

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 (if appropriate)

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
33039AlbuminIn Process
33040Alpha 1-GlobulinIn Process
33041Alpha 2-GlobulinIn Process
33042Beta-GlobulinIn Process
33043Gamma-GlobulinIn Process
33044A/G RatioIn Process
33045M spikeIn Process
33046M spikeIn Process
33047ImpressionIn Process
PTCONProtein, Total, Random, U2888-6