Test Id : MPSS
Monoclonal Protein Study, Serum
This test is only orderable for clients who send specimens directly to MCL in Jacksonville, FL. All other clients, see Rochester Test QMPSS.
Useful For
Suggests clinical disorders or settings where the test may be helpful
Diagnosis of monoclonal gammopathies, when used in conjunction with urine monoclonal studies
Monitoring patients with monoclonal gammopathies
Protein electrophoresis alone is not considered an adequate screen 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 Id | Reporting Name | Available Separately | Always Performed |
|---|---|---|---|
| TPE | Total Protein | Yes, (order TP) | Yes |
| ELP | Protein Electrophoresis | No | Yes |
| IMFX | Immunofixation | Yes, (order IMFXO) | 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.
This test includes total protein, serum protein electrophoresis, and immunofixation. If a monoclonal light chain is detected in the absence of an associated monoclonal heavy chain, an immunofixation electrophoresis (IFE) specific for delta and epsilon chains is performed.
The following algorithms are available:
Method Name
A short description of the method used to perform the test
TPE: Colorimetric, Biuret
ELP: Agarose Gel Electrophoresis
IMFX, IFXED: Immunofixation
NY State Available
Indicates the status of NY State approval and if the test is orderable for NY State clients.
Reporting Name
Lists a shorter or abbreviated version of the Published Name for a test
Aliases
Lists additional common names for a test, as an aid in searching
Immunoelectrophoresis, Serum
Immunofixation Electrophoresis (IFE)
Immunofixation, Serum
Immunotyping
MGUS (Monoclonal Gammopathy of Unknown Significance)
Multiple Myeloma
Paraprotein
Special Protein Studies
IFE (Immunofixation Electrophoresis)
This test is only orderable for clients who send specimens directly to MCL in Jacksonville, FL. All other clients, see Rochester Test QMPSS.
Testing Algorithm
Delineates situations when tests are added to the initial order. This includes reflex and additional tests.
This test includes total protein, serum protein electrophoresis, and immunofixation. If a monoclonal light chain is detected in the absence of an associated monoclonal heavy chain, an immunofixation electrophoresis (IFE) specific for delta and epsilon chains is performed.
The following algorithms are available:
Specimen Type
Describes the specimen type validated for testing
Serum
Ordering Guidance
To monitor a patient with an established diagnosis of a monoclonal gammopathy, order PELO / M-Spike Follow-up, 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: 1 mL
Collection Instructions: Centrifuge and aliquot serum into a plastic vial.
Special Instructions
Library of PDFs including pertinent information and forms related to the test
Specimen Minimum Volume
Defines the amount of sample necessary to provide a clinically relevant result as determined by the testing laboratory. The minimum volume is sufficient for one attempt at testing.
0.6 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 | |
| Ambient | 14 days | ||
| Frozen | 14 days |
This test is only orderable for clients who send specimens directly to MCL in Jacksonville, FL. All other clients, see Rochester Test QMPSS.
Useful For
Suggests clinical disorders or settings where the test may be helpful
Diagnosis of monoclonal gammopathies, when used in conjunction with urine monoclonal studies
Monitoring patients with monoclonal gammopathies
Protein electrophoresis alone is not considered an adequate screen for monoclonal gammopathies.
Testing Algorithm
Delineates situations when tests are added to the initial order. This includes reflex and additional tests.
This test includes total protein, serum protein electrophoresis, and immunofixation. If a monoclonal light chain is detected in the absence of an associated monoclonal heavy chain, an immunofixation electrophoresis (IFE) specific for delta and epsilon chains is performed.
The following algorithms are available:
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 has been recommended that serum and urine protein electrophoresis (PEL) and immunofixation electrophoresis (IFE) be performed as the diagnostic algorithm. 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 or lambda 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.
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.
The following algorithms are available:
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.
IMMUNOFIXATION
No monoclonal protein detected
IMMUNOFIXATION FLAG
Negative
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 and should be followed by MPSU / Monoclonal Protein Study, 24 Hour, Urine, which includes immunofixation (IF), 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.
-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 SVISC / 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 greater than 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 PEL should not be used to screen for the disorder.
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.
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 (IGG / Immunoglobulin G [IgG], Serum) should be performed to accurately determine M-spike concentrations to monitor 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. 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. Keren DF, Humphrey RL: Clinical indications and applications of serum and urine protein electrophoresis. In: Detrick B, Schmitz JL, Hamilton RG, eds. Manual of Molecular and Clinical Laboratory Immunology. 8th ed. ASM Press; 2016:74-88
2. Katzmann JA, Keren DF: Strategy for detecting and following monoclonal gammopathies. In: Detrick B, Schmitz JL, Hamilton RG, eds. Manual of Molecular and Clinical Laboratory Immunology. 8th ed. ASM Press; 2016:112-124
3. 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
This test is only orderable for clients who send specimens directly to MCL in Jacksonville, FL. All other clients, see Rochester Test QMPSS.
Method Description
Describes how the test is performed and provides a method-specific reference
Electrophoresis:
Proteins are large molecules composed of covalently linked amino acids. Depending on electron distributions resulting from covalent or ionic bonding of structural subgroups, proteins can be either polar or nonpolar at a given pH. In the SPIFE TOUCH SPE procedure, proteins are separated according to their respective electrical charges on agarose gel using both the electrophoretic and electroendosmotic forces present in the system. The proteins are then stained with a visible stain. Multiplying by the serum total protein converts the percentage of protein in each fraction into serum concentration. (Package insert: Helena SPIFE TOUCH SPE Procedure. Helena Laboratories; 06/2018)
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, and 9IF. Sebia, Inc; 09/2015)
If a monoclonal light chain is detected in the absence of an associated monoclonal heavy chain, an immunofixation electrophoresis (IFE) specific for delta and epsilon chains is performed.(Sykes E, Posey Y: Immunochemical characterization of immunoglobulins in serum, urine, and cerebrospinal fluid. In: Detrick B, Schmitz JL, Hamilton RG, eds. Manual of Molecular and Clinical Laboratory Immunology. 8th ed. ASM Press; 2016:89-100)
Total Protein:
Divalent copper reacts in alkaline solution with protein peptide bonds to form the characteristic purple-colored biuret complex. Sodium potassium tartrate prevents the precipitation of copper hydroxide and potassium iodide prevents autoreduction of copper. The color intensity is directly proportional to the protein concentration which can be determined photometrically.(Package insert: TP2 cobas. Roche Diagnostics; V 12.0. 11/2019)
PDF Report
Indicates whether the report includes an additional document with charts, images or other enriched information
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.
Specimen Retention Time
Outlines the length of time after testing that a specimen is kept in the laboratory before it is discarded
Performing Laboratory Location
Indicates the location of the laboratory that performs the test
This test is only orderable for clients who send specimens directly to MCL in Jacksonville, FL. All other clients, see Rochester Test QMPSS.
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 account representative. 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.
CPT codes are provided by the performing laboratory.
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 |
|---|---|---|
| MPSS | Monoclonal Protein Study, 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.
|
|---|---|---|
| 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 |