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Test ID: PEL
Electrophoresis, Protein, Serum

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

80085

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

 

Diagnosis of monoclonal gammopathies, when used in conjunction with immunofixation

 

Protein electrophoresis alone is not considered an adequate screening for 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
TPETotal ProteinYes, (order TP)Yes
ELPProtein ElectrophoresisNoYes

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
IMFXImmunofixationNoNo

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 serum protein electrophoresis and, if necessary, perform immunofixation at an additional charge.

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

TPE/20698: Biuret

ELP/20700: Agarose Gel Electrophoresis

IMFX/81653: Immunofixation and/or Immunodiffusion

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

Electrophoresis, Protein, S

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 81756)
Protein Electrophoresis+Total Protein
SPE (Serum Protein Electrophoresis)
SPEP (Serum Protein Electrophoresis)

Specimen Type Describes the specimen type needed for testing

Serum

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.

If a urine specimen on the same patient will also be submitted, order EPU/82441 Electrophoresis, Protein, Urine under a separate order.

 

Container/Tube:

Preferred: Red top

Acceptable: Serum gel

Specimen Volume: 1 mL

Collection Instructions: Fasting

Additional Information: Indicate if multiple myeloma is suspected.

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.

0.5 mL

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

Hemolysis

Mild OK; Gross OK

Lipemia

Mild OK; Gross OK

Icterus

Mild OK; Gross OK

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
SerumRefrigerated (preferred)7 days
 Frozen 14 days
 Ambient 72 hours

Clinical Information Discusses physiology, pathophysiology, and general clinical aspects, as they relate to a laboratory test

Serum proteins can be grouped into 5 fractions by protein electrophoresis:

-Albumin, which represents almost 2/3 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 (Ig)

 

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.

PROTEIN, TOTAL

> 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.

Interpretation Provides information to assist in interpretation of the test results

Monoclonal gammopathies:

-A characteristic monoclonal band (M-spike) is often found on protein electrophoresis (PEL) 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 PEL pattern is suggestive of a possible monoclonal protein and should be followed by MPSU/8823 Monoclonal Protein Study, Urine, which includes immunofixation (IF), to identify the immunoglobulin heavy chain and/or light chain.

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

-A monoclonal IgG or IgA <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 >3 g/dL is consistent with macroglobulinemia.

-The initial identification of a serum M-spike >1.5 g/dL on PEL should be followed by MPSU/8823 Monoclonal Protein Study, Urine.

-The initial identification of an IgM, IgA, or IgG M-spike >4 g/dL, >5 g/dL, and >6 g/dL respectively, should be followed by VISCS/8168 Viscosity, Serum.

-After the initial identification of an M-spike, quantitation of the M-spike on follow-up PEL 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 PEL. A decrease or increase of the M-spike that is >0.5 g/dL is considered a significant change.

-Patients suspected of having a monoclonal gammopathy may have normal serum PEL patterns. Approximately 11% of patients with MM have a completely normal serum PEL, with the monoclonal protein only identified by IF. Approximately 8% of MM patients have hypogammaglobulinemia without a quantifiable M-spike on PEL but identified by IF. Accordingly, a normal serum PEL does not rule out the disease and should not be used to screen for the disorder. The MPSS/81756 Monoclonal Protein Study, Serum, which includes IF, should be done to screen if the clinical suspicion is high.

 

Other abnormal PEL 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 >40 years, should be followed by MPSU/8823 Monoclonal Protein Study, 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/8161 Alpha-1- Antitrypsin, Serum).

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

A normal serum protein electrophoresis (PEL) does not rule out disease. MPSS/81756 Monoclonal Protein Study, Serum, which includes immunofixation, should be done to screen if the clinical suspicion is high.

 

Very large IgG M-spikes (>4 g/dL) may saturate the protein stain. In these situations, quantitative IgG assays (IGG/8160 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 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. 6th edition. Edited by NR Rose, et al: Washington DC, ASM Press, 2002 pp 66-70

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

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 (Helena Quick Scan 2000). Multiplying by the serum total protein converts the percentage of protein in each fraction into serum concentration. (Instruction manual: Helena SPIFE 3000; package insert: Helena SPIFE SPE Vis Gel, 2001; Kyle RA, Katzmann JA, Lust JA, Dispenzieri 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 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.

Monday through Saturday; Continuously until 2 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.

1 day

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

2 days

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

7 days

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.

84155-Protein, total

84165-Electrophoresis, protein

86334-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
TPETotal Protein2885-2
2769Albumin2862-1
2770Alpha-1 Globulin2865-4
2771Alpha-2 Globulin2868-8
2773Beta-Globulin2871-2
2774Gamma-Globulin2874-6
2785A/G Ratio44429-9
22308M spike33358-3
22309M spike33358-3
15254Impression12851-2