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HelpTest Code MPSS Monoclonal Protein Study, Serum
Ordering Guidance
To monitor a patient with an established diagnosis of a monoclonal gammopathy, order PELO / M-Spike Follow-up, Serum.
Specimen Required
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.
Useful For
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
| 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 |
Testing Algorithm
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
TPE: Colorimetric, Biuret
ELP: Agarose Gel Electrophoresis
IMFX, IFXED: Immunofixation
Reporting Name
Monoclonal Protein Study, SSpecimen Type
SerumSpecimen Minimum Volume
0.6 mL
Specimen Stability Information
| Specimen Type | Temperature | Time |
|---|---|---|
| Serum | Refrigerated (preferred) | 14 days |
| Ambient | 14 days | |
| Frozen | 14 days |
Reject Due To
| Gross hemolysis | OK |
| Gross lipemia | OK |
| Gross icterus | OK |
Clinical Information
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
PROTEIN, TOTAL
≥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
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
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
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
Day(s) Performed
Monday through Friday
Report Available
1 to 6 daysSpecimen Retention Time
14 daysPerforming Laboratory
Mayo Clinic Laboratories in Florida
Test Classification
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
84155
84165
86334
86334-Immunofixation Delta and Epsilon (if appropriate)
LOINC Code Information
| Test ID | Test Order Name | Order LOINC Value |
|---|---|---|
| MPSS | Monoclonal Protein Study, S | 24351-9 |
| Result ID | Test Result Name | Result LOINC Value |
|---|---|---|
| TPE | Total Protein | 2885-2 |
| 2769 | Albumin | 2862-1 |
| 81653 | Immunofixation | 74665-1 |
| 606977 | Flag, Immunofixation | No LOINC Needed |
| 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 |
Reflex Tests
| Test ID | Reporting Name | Available Separately | Always Performed |
|---|---|---|---|
| IFXED | Immunofixation Delta and Epsilon, S | Yes | No |