Test Catalog

Test Id : MPEP

Monoclonal Protein Study, Expanded Panel, Serum

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

Diagnosis of monoclonal gammopathies

 

Eliminating the need for urine monoclonal studies as a part of initial diagnostic studies (ie, rule-out monoclonal gammopathy)

 

Assessing risk of progression from monoclonal gammopathy of undetermined significance to multiple myeloma

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
ELP Protein Electrophoresis Yes, (order PEL) Yes
IMFX Immunofixation Yes, Order IMFXO) Yes
KFLCS Kappa Free Light Chain, S Yes, (order FLCS) Yes
LFLCS Lambda Free Light Chain, S Yes, (order FLCS) Yes
KLRS Kappa/Lambda FLC Ratio Yes, (order FLCS) 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

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

Includes total protein, serum protein electrophoresis, and heavy-chain and light-chain typing (kappa and lambda). If a monoclonal light chain is detected in the absence of an associated monoclonal heavy chain, an immunofixation electrophoresis specific for delta and epsilon chains is performed.

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

TPE: Biuret

ELP: Agarose Gel Electrophoresis

IMFX, IFXED: Immunofixation

KFLCS, LFLCS: Turbidimetry

KLRS: Calculation

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

No

Reporting Name
Lists a shorter or abbreviated version of the Published Name for a test

Monoclonal Protein Expanded Panel,S

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

IEP (Immunoelectrophoresis)

Immunofixation

Immunotyping

Kappa-Free Light Chain

Lambda-Free Light Chain

Monoclonal Gammopathy of Unknown Significance (MGUS)

Multiple Myeloma

Myeloma Studies

Paraprotein

Protein Analysis, Myeloma

Protein Electrophoresis

Special Protein Studies

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

Includes total protein, serum protein electrophoresis, and heavy-chain and light-chain typing (kappa and lambda). If a monoclonal light chain is detected in the absence of an associated monoclonal heavy chain, an immunofixation electrophoresis specific for delta and epsilon chains is performed.

Specimen Type
Describes the specimen type validated for testing

Serum

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

Patient Preparation: Fasting preferred but not required

Collection Container/Tube: 

Preferred: Serum gel

Acceptable: Red top

Submission Container/Tube: Plastic vial

Specimen Volume: 2 mL

Specimen Minimum Volume
Defines the amount of sample necessary to provide a clinically relevant result as determined by the Testing Laboratory

1.5 mL

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

Gross lipemia Reject

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 72 hours

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

Diagnosis of monoclonal gammopathies

 

Eliminating the need for urine monoclonal studies as a part of initial diagnostic studies (ie, rule-out monoclonal gammopathy)

 

Assessing risk of progression from monoclonal gammopathy of undetermined significance to multiple myeloma

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

Includes total protein, serum protein electrophoresis, and heavy-chain and light-chain typing (kappa and lambda). If a monoclonal light chain is detected in the absence of an associated monoclonal heavy chain, an immunofixation electrophoresis specific for delta and epsilon chains is performed.

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

Monoclonal proteins are markers of plasma cell proliferative disorders. It is recommended that serum and urine protein electrophoresis (PEL) and immunofixation electrophoresis (IFE) be performed as part of the diagnostic algorithm (eg, MPSS / Monoclonal Protein Study, Serum and MPSU / Monoclonal Protein Study, 24 Hour, Urine). A monoclonal band (M-spike) on serum and/or urine PEL identifies a monoclonal process and quantitates the abnormality. IFE characterizes the type of monoclonal protein (gamma, alpha, mu, delta, or epsilon heavy chain; kappa [K] or lambda [L] light chain). IFE is also more sensitive than PEL for detecting small abnormalities that may be present in diseases such as light chain multiple myeloma, oligosecretory myeloma, and plasmacytomas.

 

With the addition of the serum free light-chain (FLC) assay, the expanded monoclonal protein study provides even more diagnostic sensitivity for the monoclonal light-chain diseases such as primary amyloid and light-chain deposition disease; disorders that often do not have serum monoclonal proteins in high enough concentration to be detected and quantitated by PEL. The FLC assay is specific for free kappa and lambda light chains and does not recognize light chains bound to intact immunoglobulin. Importantly, the addition of the serum FLC assay to serum PEL and IFE makes the serum diagnostic studies sufficiently sensitive so that urine specimens are no longer required as part of initial diagnostic studies.

 

Monoclonal gammopathies may be present in a wide spectrum of diseases that include malignancies of plasma cells or B lymphocytes (multiple myeloma [MM], macroglobulinemia, plasmacytoma, B-cell lymphoma), disorders of monoclonal protein structure (primary amyloid, light-chain deposition disease, cryoglobulinemia), and apparently benign, premalignant conditions (monoclonal gammopathy of undetermined significance [MGUS], smoldering MM). While the identification of the monoclonal gammopathy is a laboratory diagnosis, the specific clinical diagnosis is dependent on a number of other laboratory and clinical assessments.

 

If a monoclonal protein pattern is detected by IFE or FLC, a diagnosis of a monoclonal gammopathy is established. Once a monoclonal gammopathy has been diagnosed, the size of the clonal abnormality can be monitored by PEL or FLC and, in some instances, by quantitative immunoglobulins. In addition, if the patient is asymptomatic and has a diagnosis of MGUS, the expanded monoclonal protein study panel provides the information (size of M-spike, monoclonal protein isotype, FLC K/L ratio) needed for a MGUS progression risk assessment (see Interpretation).

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 younger than 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

M-spike: 0.0 g/dL

An interpretive comment is provided with the report.

Reference values have not been established for patients that are younger than 16 years of age

 

IMMUNOFIXATION

Immunofixation: No monoclonal protein detected

Flag, Immunofixation: Negative

 

KAPPA-FREE LIGHT CHAIN

0.33-1.94 mg/dL

 

LAMBDA-FREE LIGHT CHAIN

0.57-2.63 mg/dL

 

KAPPA/LAMBDA-FREE LIGHT-CHAIN RATIO

0.26-1.65

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 an M-spike, restricted migration, or hypogammaglobulinemic PEL pattern is suggestive of a possible monoclonal protein. Immunofixation electrophoresis (IFE) is performed to identify the immunoglobulin heavy chain and/or light chain.

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

-A monoclonal IgG or IgA of 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 of greater than 3 g/dL is consistent with macroglobulinemia.

-An abnormal serum free light chain (FLC) kappa/lambda (K/L) ratio in the presence of a normal IFE suggests a monoclonal light-chain process and should be followed by MPSU / Monoclonal Protein Study, 24 Hour, Urine.

-The initial identification of a serum M-spike greater than 1.5 g/dL on PEL 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 a monoclonal band, 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 greater than 0.5 g/dL is considered a significant change.

-Patients with monoclonal light chain diseases who have no serum or urine M-spike may be monitored with the serum FLC value.

-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 IFE. Approximately 8% of MM patients have hypogammaglobulinemia without a quantifiable M-spike on PEL but identified by IFE and/or FLC. Accordingly, a normal serum PEL does not rule out the disease and PEL alone should not be used to screen for the disorder if the clinical suspicion is high.

 

MGUS Prognosis:

-Low-risk MGUS patients are defined as having an M-spike of less than 1.5 g/dL, IgG monoclonal protein, and a normal FLC K/L ratio (0.25-1.65), and these patients have a lifetime risk of progression to MM of less than 5%.

-High-risk MGUS patients (M-spike >1.5, IgA or IgM, abnormal FLC ratio) have a lifetime risk of progression to MM of 60%.

 

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 (>1.2 g/dL), and decreased gamma fraction (<1 g/dL) is consistent with nephritic 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

Protein electrophoresis (PEL) alone is not considered an adequate screen for monoclonal gammopathies.

 

Very large IgG M-spikes (>4 g/dL) may saturate the protein stain. In these situations, quantitative IgG assays more accurately determine M-spike concentrations for monitoring disease progression or response to therapy.

 

Although the PEL M-spike is the recommended method of monitoring monoclonal gammopathies, IgA and IgM proteins that are contained in the beta fraction may be more accurately monitored by quantitative immunoglobulins.

 

Fibrinogen will migrate as a distinct band in the beta-gamma fraction but will be negative on immunofixation electrophoresis.

 

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. 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

2. Rajkumar SV, Kyle RA, Therneau TM, et al: Serum free light chain ratio is an independent risk factor for progression in monoclonal gammopathy of undetermined significance. Blood. 2005;106:812-817

3. Katzmann JA, Dispenzieri A, Kyle RA, et al: Elimination of the need for urine studies in the screening algorithm for monoclonal gammopathies by using serum immunofixation and free light chain assays. Mayo Clin Proc. 2006;81(12):1575-1578

4. Katzmann JA, Keren DF. Strategy for detecting and following monoclonal gammopathies. In: Detrick BD, Hamilton RG, Schmitz JL, eds. Manual of Molecular and Clinical Laboratory Immunology. 8th ed. ASM Press; 2016:112-124

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 amido black and the intensity of staining is quantitated by densitometry (Sebia HYDRASYS 2 Scan). Multiplying by the serum total protein converts the percentage of protein in each fraction into serum concentration.(Package insert: Hydragel 30 Protein [E]. Sebia, Inc; 12/2017)

 

Immunofixation:

Immunofixation is performed with Sebia reagent sets and are specific for gamma, alpha, mu, kappa, and lambda immunoglobulin heavy and light chains.(Package insert: Sebia Hydrasys Hydragel 1, 2, 4, 9IF, Sebia Inc; 09/2015)

 

Free Light Chains:

The quantitation of free light chain (FLC) by turbidimetry uses FLC antisera. Undetected antigen excess is a rare event but cannot be excluded. If the free light chain results do not agree with other clinical or laboratory findings, or if the sample is from a patient that has previously demonstrated antigen excess, the result must be checked by retesting at a higher sample dilution. Results should always be interpreted in conjunction with other laboratory tests and clinical evidence; any anomalies should be discussed with the testing laboratory.(Package inserts: Optilite Freelite Kappa Free Kit. The Binding Site Group, Ltd; 06/2015; Optilite Freelite Lambda Free Kit. The Binding Site Group, Ltd; 06/2015)

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.

Same day/1 to 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
Indicates the location of the laboratory that performs the test

Jacksonville

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 has been cleared, approved, or is exempt by the US 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 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.

83521 x 2

84155

84165

86334

86334-Immunofixation Delta and Epsilon (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
MPEP Monoclonal Protein Expanded Panel,S 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.
81653 Immunofixation 74665-1
606977 Flag, Immunofixation No LOINC Needed
TPE Total Protein 2885-2
2769 Albumin 2862-1
2770 Alpha-1 Globulin 2865-4
2771 Alpha-2 Globulin 2868-8
2773 Beta-Globulin 2871-2
2774 Gamma-Globulin 2874-6
2785 A/G Ratio 44429-9
22308 M spike 33358-3
22309 M spike 33358-3
15254 Impression 49296-7
LFLCS Lambda Free Light Chain, S 33944-0
KLRS Kappa/Lambda FLC Ratio 48378-4
KFLCS Kappa Free Light Chain, S 36916-5

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
New Test 2022-10-04