Test ID: MPSS
Monoclonal Protein Study, Serum
Secondary ID 
A test code used for billing and in test definitions created prior to November 2011
NY State Approved Indicates the status of NY State approval and if the test is orderable for NY State clients.
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 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 ID | Reporting Name | Available Separately | Always Performed |
|---|---|---|---|
| TPE | Total Protein | Yes, (order TP) | Yes |
| ELP | Protein Electrophoresis | No | Yes |
| IMFX | Immunofixation | No | Yes |
Testing Algorithm Delineates situation(s) when tests are added to the initial order. This includes reflex and additional tests.
Includes total protein, serum protein electrophoresis (SPEP), heavy-chain typing, and light-chain typing (kappa and lambda).
The following algorithms are available in Special Instructions:
-Laboratory Approach to the Diagnosis of Amyloidosis
-Laboratory Screening Tests for Suspected Multiple Myeloma
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
TPE/20698: Biuret
ELP/20700: Agarose Gel Electrophoresis
IMFX/81653: Immunofixation
Reporting Name A shorter/abbreviated version of the Published Name for a test; an abbreviated test name
Aliases Lists additional common names for a test, as an aid in searching
Immunofixation Electrophoresis (IFE)
Immunofixation, Serum
Immunotyping
MGUS (Monoclonal Gammopathy of Unknown Significance)
Multiple Myeloma
Paraprotein
Special Protein Studies
IFE (Immunofixation Electrophoresis)
Specimen Type Describes the specimen type needed for testing
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.
Container/Tube:
Preferred: Red top
Acceptable: Serum gel
Specimen Volume: 1 mL
Collection Instructions: Fasting
Additional Information: If a urine specimen on the same patient will also be submitted, order MPSU/8823 Monoclonal Protein Study, Urine under a separate order number.
Forms: If not ordering electronically, submit a General Request Form (Supply T239) with the specimen.
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.
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 Type | Temperature | Time |
|---|---|---|
| Serum | Refrigerated (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 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 complement 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.
The following algorithms are available in Special Instructions:
-Laboratory Approach to the Diagnosis of Amyloidosis
-Laboratory Screening Tests for Suspected Multiple Myeloma
Also see Diagnosis and Monitoring of Multiple Myeloma in Publications.
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.
Reference values have not been established for patients that are <16 years of age.
IMMUNOFIXATION
Negative (reported as positive or 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/8823 Monoclonal Protein Study, Urine, which includes immunofixation (IF), to identify the immunoglobulin (Ig) 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 PEL should not be used to screen for the disorder. 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 (>1.2 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/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
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. Sixth 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.(Package insert: Helena SPIFE 3000 Instruction Manual and Helena SPIFE SPE Vis Gel 2001; Kyle RA, Katzmann JA, Lust JA, Dispenzieri A: Chapter 8: Immunochemical characterization of immunoglobulins. In Manual of Clinical Laboratory Immunology. Sixth 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; 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.
Maximum Laboratory Time Defines the maximum time from specimen receipt at Mayo Medical Laboratories until the release of the test result
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 The location of the laboratory that performs the test
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.
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-Protein electrophoresis
86334-Immunofixation
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 ID | Reporting Name | LOINC Code |
|---|---|---|
| 81653 | Immunofixation | 33879-8 |
| 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 | 12851-2 |
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