Test Catalog

Test Id : SPEP

Electrophoresis, Protein, Serum

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

Screening patients with suspected monoclonal gammopathies

 

Diagnosis of monoclonal gammopathies, when used in conjunction with matrix-assisted laser desorption/ionization-time of flight mass spectrometry (MALDI-TOF MS) and free light chain analysis

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
TPE Total Protein Yes, (Order TP) Yes
SPE Protein Electrophoresis No 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
IFXED Immunofixation Delta and Epsilon, S Yes No
MPTS M-protein Isotype MALDI-TOF MS, S Yes, (Order MALD) No

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

This test includes total protein and serum protein electrophoresis.

 

If a discrete electrophoresis band is identified, the laboratory will evaluate the serum protein electrophoresis and, if necessary, perform M-protein isotype at an additional charge.

 

If a light chain is identified without a corresponding heavy chain during initial testing, immunofixation with IgD and IgE antisera will be performed at an additional charge.

 

The following algorithms are available:

-Amyloidosis: Laboratory Approach to Diagnosis

-Multiple Myeloma: Laboratory Screening

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

TPE: Colorimetric, Biuret

SPE: Agarose Gel Electrophoresis

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

Electrophoresis, Protein, S

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

Protein Electrophoresis

Immunology Profile

Macroglobulins

Serum immunoglobulins

Protein Electrophoresis +Total Protein

SPE (Serum Protein Electrophoresis)

SPEP (Serum Protein Electrophoresis)

SPEP

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

This test includes total protein and serum protein electrophoresis.

 

If a discrete electrophoresis band is identified, the laboratory will evaluate the serum protein electrophoresis and, if necessary, perform M-protein isotype at an additional charge.

 

If a light chain is identified without a corresponding heavy chain during initial testing, immunofixation with IgD and IgE antisera 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

Serum

Ordering Guidance

Protein electrophoresis alone is not considered an adequate screen for monoclonal gammopathies. When screening a patient or establishing a first-time diagnosis for a monoclonal gammopathy, consider ordering DMOGA / Monoclonal Gammopathy, Diagnostic, Serum instead, which includes free light chain analysis and isotyping by matrix-assisted laser desorption/ionization-time of flight mass spectrometry (MALDI-TOF MS).

 

If free light chain testing has already been performed locally, PEISO / Protein Electrophoresis and Isotype, Serum may be ordered instead of DMOGA / Monoclonal Gammopathy, Diagnostic, Serum for a first-time diagnosis.

 

For monitoring patients with a diagnosis of monoclonal gammopathy, order TMOGA / Monoclonal Gammopathy, Monitoring, Serum.

Necessary Information

Indicate if multiple myeloma is suspected.

Specimen Required
Defines the optimal specimen required to perform the test and the preferred volume to complete testing

Patient Preparation: Fasting (12 hour) preferred but not required

Container/Tube:

Preferred: Serum gel

Acceptable: Red top

Specimen Volume: 1 mL

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

0.5 mL

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

Gross hemolysis OK
Gross lipemia OK
Gross icterus OK

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
Serum Refrigerated (preferred) 14 days
Frozen 14 days
Ambient 7 days

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

Screening patients with suspected monoclonal gammopathies

 

Diagnosis of monoclonal gammopathies, when used in conjunction with matrix-assisted laser desorption/ionization-time of flight mass spectrometry (MALDI-TOF MS) and free light chain analysis

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

This test includes total protein and serum protein electrophoresis.

 

If a discrete electrophoresis band is identified, the laboratory will evaluate the serum protein electrophoresis and, if necessary, perform M-protein isotype at an additional charge.

 

If a light chain is identified without a corresponding heavy chain during initial testing, immunofixation with IgD and IgE antisera 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

This profile includes both total protein and protein electrophoresis. The serum proteins can be grouped into 5 fractions by protein electrophoresis:

-Albumin, which represents almost two-thirds of the total serum protein

-Alpha-1, composed primarily of alpha-1-antitrypsin (A1AT), an alpha-1-acid glycoprotein

-Alpha-2, composed primarily of alpha-2-macroglobulin and haptoglobin

-Beta, composed primarily of transferrin and C3

-Gamma, composed primarily of immunoglobulins

 

The concentration of these fractions and the electrophoretic pattern may be characteristic of diseases such as monoclonal gammopathies, A1AT deficiency disease, nephrotic syndrome, and inflammatory processes associated with infection, liver disease, and autoimmune diseases.

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.

TOTAL PROTEIN

> or =1 year: 6.3-7.9 g/dL

Reference values have not been established for patients that are <12 months of age.

 

PROTEIN ELECTROPHORESIS

Albumin: 3.4-4.7 g/dL

Alpha-1-globulin: 0.1-0.3 g/dL

Alpha-2-globulin: 0.6-1.0 g/dL

Beta-globulin: 0.7-1.2 g/dL

Gamma-globulin: 0.6-1.6 g/dL

An interpretive comment is provided with the report.

Reference values have not been established for patients that are <16 years of age.

Interpretation
Provides information to assist in interpretation of the test results

Monoclonal Gammopathies:

A characteristic monoclonal band (M-spike) is often found on serum protein electrophoresis (SPE) in the gamma-globulin region and, more rarely, in the beta or alpha-2 regions. The finding of a M-spike, restricted migration, or hypogammaglobulinemic SPE pattern is suggestive of a possible monoclonal protein and should be confirmed by immunoaffinity-purification matrix-assisted laser desorption/ionization-time of flight mass spectrometry (MALDI-TOF MS) to identify any immunoglobulin heavy or light chains. A MPSU / Monoclonal Protein Study, 24 Hour, Urine is suggested for first-time M-spike patients to assess for renal disease that can be associated with an M-spike.

-A monoclonal IgG or IgA greater than 3 g/dL is consistent with multiple myeloma (MM).

-A monoclonal IgG or IgA less than 3 g/dL may be consistent with monoclonal gammopathy of undetermined significance (MGUS), primary systemic amyloidosis, early or treated myeloma, as well as a number of other monoclonal gammopathies.

-A monoclonal IgM greater than 3 g/dL is consistent with macroglobulinemia.

-The initial identification of a serum M-spike greater than 1.5 g/dL on SPE should be followed by MPSU / Monoclonal Protein Study, 24 Hour, Urine.

-The initial identification of an IgM, IgA, or IgG M-spike greater than 4 g/dL, greater than 5 g/dL, and greater than 6 g/dL, respectively, should be followed by VISCS / Viscosity, Serum.

 

After the initial identification of an M-spike, quantitation of the M-spike on follow-up SPE can be used to monitor the monoclonal gammopathy. However, if the monoclonal protein falls within the beta region (most commonly an IgA or an IgM) quantitative immunoglobulin levels may be more a useful tool to follow the monoclonal protein level than SPE. A decrease or increase of the M-spike that is greater than 0.5 g/dL is considered a significant change.

 

Patients suspected of having a monoclonal gammopathy may have normal serum SPE patterns. Approximately 11% of patients with MM have a completely normal serum SPE, with the monoclonal protein only identified by MALDI-TOF MS. Approximately 8% of MM patients have hypogammaglobulinemia without a quantifiable M-spike on SPE but identified by MALDI-TOF MS. Accordingly, a normal serum SPE does not rule out the disease and should not be used to screen for the disorder. The DMOGA / Monoclonal Gammopathy, Diagnostic, Serum, which includes MALDI-TOF MS, and serum free light chains, conforms to the International Myeloma Working Group (IMWG) guidelines for screening and should be performed if there is clinical suspicion.

 

Other Abnormal SPE Findings:

-A qualitatively normal but elevated gamma fraction (polyclonal hypergammaglobulinemia) is consistent with infection, liver disease, or autoimmune disease.

-A depressed gamma fraction (hypogammaglobulinemia) is consistent with immune deficiency and can also be associated with primary amyloidosis or nephrotic syndrome.

-A decreased albumin (<2 g/dL), increased alpha-2 fraction (>1.1 g/dL), and decreased gamma fraction (<1 g/dL) is consistent with nephrotic syndrome, and when seen in an adult older than 40 years, should be followed by MPSU / Monoclonal Protein Study, 24 Hour, Urine.

-In the hereditary deficiency of a protein (eg, agammaglobulinemia, alpha-1-antitrypsin [A1AT] deficiency, hypoalbuminemia), the affected fraction is faint or absent.

-An absent alpha-1 fraction is consistent with A1AT deficiency disease and should be followed by a quantitative A1AT assay (AAT / Alpha-1- Antitrypsin, Serum).

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

Very large IgG M-spikes (>4 g/dL) may saturate the protein stain. In these situations, quantitative IgG assays (IGG / Immunoglobulin G [IgG], Serum) should be performed to accurately determine M-spike concentrations to monitor disease progression or response to therapy.

 

Fibrinogen will migrate as a distinct band in the beta-gamma fraction. Serum specimens from new patients with a beta-gamma band are to be treated with thrombin to ensure complete conversion of fibrinogen.

 

Hemolysis may augment the beta fraction.

 

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. 2002:66-70

2. Mills JR, Kohlhagen MC, Dasari S, et al: Comprehensive assessment of M-Proteins using nanobody enrichment coupled to MALDI-TOF mass spectrometry. Clin Chem. 2016 Oct;62(10):1334-1344

3. 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

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:

Serum proteins are separated in an electric field according to their size, shape, and electric charge. 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. Multiplying by the serum total protein (Coomasie blue) converts the percentage of protein in each fraction into serum concentration.(Instruction manual: Helena SPIFE Touch. Helena Laboratories, Corp; 11/2016; package insert: Helena SPIFE Touch SPE Pro 277. Helena Laboratories, Corp; 06/2018)

 

Immunofixation

Immunofixation is performed with Sebia reagent sets that are specific for delta and epsilon immunoglobulin heavy chains and kappa and lambda light chains. Immunofixation electrophoresis is performed in four stages: 1) separation of proteins by electrophoresis on an agarose gel; 2) immunofixation (immunoprecipitation) and fixation of the electrophoresed proteins;3) removal of unprecipitated soluble proteins by blotting and washing;, and 4) staining of the precipitated proteins for visualization.(Package insert: Sebia HYDRAGEL 1, 2, 4 and 9 IF kit. Sebia Inc; 07/2020)

 

M-protein Isotype:

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 broken down into their reduced to separate the heavy and light chains subunits to be analyzed via MALDI-TOF mass spectrometry. 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;92(8):772-779. doi: 10.1002/ajh.24772)

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.

2 to 5 days

Specimen Retention Time
Outlines the length of time after testing that a specimen is kept in the laboratory before it is discarded

14 days

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 Regional Manager. 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. 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.

84155

84165

0077U (if appropriate)

86334 (if appropriate)

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
SPEP Electrophoresis, Protein, S 24351-9
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.
TPE Total Protein 2885-2
602837 Albumin 2862-1
602838 Alpha-1 Globulin 2865-4
602839 Alpha-2 Globulin 2868-8
602840 Beta-Globulin 2871-2
602841 Gamma-Globulin 2874-6
602842 A/G Ratio 44429-9
602843 M spike 51435-6
602844 M spike 35559-4
602836 Impression 49296-7

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 | Create a 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