Test ID MPSS Monoclonal Protein Study, Serum
Reporting Name
Monoclonal Protein Study, SUseful 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 heavy and light chain typing (kappa and lambda).
The following algorithms are available in Special Instructions:
Specimen Type
SerumAdvisory Information
To monitor a patient with an established diagnosis of a monoclonal gammopathy, order MMOGA / Monoclonal Gammopathy Monitoring, Serum.
Specimen Required
Patient Preparation: Fasting preferred but not required
Container/Tube:
Preferred: Serum gel
Acceptable: Red top
Specimen Volume: 1 mL
Specimen Minimum Volume
0.6 mL
Specimen Stability Information
Specimen Type | Temperature | Time | Special Container |
---|---|---|---|
Serum | Refrigerated (preferred) | 14 days | |
Ambient | 14 days | ||
Frozen | 14 days |
Special Instructions
Reference Values
PROTEIN, TOTAL
≥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
No monoclonal protein detected
Day(s) and Time(s) Performed
Monday through Friday; 2 p.m.
Test Classification
This test has been cleared, approved or is exempt 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
84155
84165
86334
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 |
---|---|---|
81653 | Immunofixation | 74665-1 |
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 |
Clinical Information
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:
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 (Ig) 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 VISCS / 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.
Clinical Reference
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, RG Hamilton, B Derick. Washington, DC. ASM Press, 2002, pp 66-70
Analytic Time
1 dayMethod Name
TPE: Biuret
ELP: Agarose Gel Electrophoresis
IMFX: Immunofixation
Forms
If not ordering electronically, complete, print, and send 1 of the following forms with the specimen:
-Renal Diagnostics Test Request (T830)
-General Request (T239)