Test ID MMOGA Monoclonal Gammopathy Monitoring, Serum
Advisory Information
Protein electrophoresis alone is not considered an adequate screen for monoclonal gammopathies. When screening a patient or establishing a first-time diagnosis for a monoclonal gammopathy, consider ordering SMOGA / Monoclonal Gammopathy Screen, Serum instead, which includes free light chain analysis.
Specimen Required
Patient Preparation: Fasting (12 hour) preferred but not required
Container/Tube:
Preferred: Serum gel
Acceptable: Red top
Specimen Volume: 1 mL
Collection Instructions: Centrifuge and aliquot serum
Useful For
Monitoring patients with monoclonal gammopathies
This test is not recommended to screen or establish a first-time diagnosis for a monoclonal gammopathy
Profile Information
Test ID | Reporting Name | Available Separately | Always Performed |
---|---|---|---|
TPE | Total Protein | Yes, (Order TP) | Yes |
SPE | Protein Electrophoresis | No | Yes |
Reflex Tests
Test ID | Reporting Name | Available Separately | Always Performed |
---|---|---|---|
IMFX | Immunofixation | Yes, (Order IMFXO) | No |
MPTS | M-protein Isotype MALDI-TOF MS, S | Yes, (Order MALDO) | No |
Testing Algorithm
This test includes total protein and serum protein electrophoresis.
If a discrete electrophoresis band is not identified, the laboratory will evaluate the serum protein electrophoresis and, if necessary, perform M-protein isotype at an additional charge.
If a light chain is identified without a corresponding heavy chain during initial testing, immunofixation with IgD and IgE antisera will be performed at an additional charge.
If a history of an IgD or IgE has been previously established and no M-spike is seen on electrophoresis, immunofixation with IgD and IgE antisera will be performed at an additional charge.
Method Name
TPE: Biuret
SPE: Agarose Gel Electrophoresis
MPTS: Matrix-assisted laser desorption/ionization-time of flight mass spectrometry (MALDI-TOF MS)
Reporting Name
Monoclonal Gammopathy Monitor, SSpecimen Type
SerumSpecimen Minimum Volume
0.5 mL
Specimen Stability Information
Specimen Type | Temperature | Time | Special Container |
---|---|---|---|
Serum | Refrigerated (preferred) | 14 days | |
Frozen | 14 days | ||
Ambient | 7 days |
Clinical Information
This profile includes both total protein and protein electrophoresis. The 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 alph-1-acid glycoprotein
-Alpha-2, composed primarily of alpha-2-macroglobulin and haptoglobin
-Beta, composed primarily of transferrin and C3
-Gamma, composed primarily of immunoglobulins
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.
Reference Values
TOTAL PROTEIN:
≥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.
Reference values have not been established for patients that are <16 years of age.
Interpretation
Monoclonal Gammopathies:
A characteristic monoclonal band (M-spike) is often found on serum protein electrophoresis (SPE) 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 SPE pattern is suggestive of a possible monoclonal protein. Immunoaffinity purification followed by matrix-assisted laser desorption/ionization-time of flight mass spectrometry (MALDI-TOF MS) is performed to identify any immunoglobulin heavy and light chains present.
-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 SPEP 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 SPE 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 SPE. 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 SPE patterns. Approximately 11% of patients with MM have a completely normal SPE, with the monoclonal protein only identified by MALDI-TOF MS. Approximately 8% of MM patients have hypogammaglobulinemia without a quantifiable M-spike on SPE, but identified by MALDI-TOF MS. Accordingly, a normal serum SPE does not rule out the disease and should not be used to screen for the disorder. SMOGA / Monoclonal Gammopathy Screen, Serum, which includes MALDI-TOF MS and serum free light chains, conforms to the International Myeloma Working Group (IMWG) guidelines for screening and should be performed if there is clinical suspicion.
Other Abnormal SPE 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 (>1.1 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).
Clinical Reference
1. 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 Detrick. Washington DC, ASM Press, 2002 pp 66-70
2. Mills JR, Kohlhagen MC, Dasari S, et al: Comprehensive Assessment of M-Proteins Using Nanobody Enrichment Coupled to MALDI-TOF Mass Spectrometry. Clin Chem. 2016;62(10):1334-1344
Day(s) and Time(s) Performed
TPE, SPE, IMFX:
Monday through Friday; 1 p.m.
MPTS:
Monday through Friday; 8 a.m.
Analytic Time
Same day/1 dayTest Classification
See Individual Test IDsCPT Code Information
84155
84165
0077U (if appropriate)
86334 (if appropriate)
LOINC Code Information
Test ID | Test Order Name | Order LOINC Value |
---|---|---|
MMOGA | Monoclonal Gammopathy Monitor, S | 24351-9 |
Result ID | Test Result Name | Result LOINC Value |
---|---|---|
TPE | Total Protein | 2885-2 |
602837 | Albumin | 2862-1 |
602838 | Alpha-1 Globulin | 2865-4 |
602839 | Alpha-2 Globulin | 2868-8 |
602840 | Beta-Globulin | 2871-2 |
602841 | Gamma-Globulin | 2874-6 |
602842 | A/G Ratio | 44429-9 |
602843 | M spike | 51435-6 |
602844 | M spike | 35559-4 |
602836 | Impression | 49296-7 |
Forms
If not ordering electronically, complete, print, and send a Renal Diagnostics Test Request (T830) with the specimen.