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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


Secondary ID

97409

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
MPTS M-protein Isotype MALDI-TOF MS, S No No
IMFX Immunofixation Yes, (Order IMFXO) 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, S

Specimen Type

Serum

Specimen Minimum Volume

0.5 mL

Specimen Stability Information

Specimen Type Temperature Time
Serum Refrigerated (preferred) 14 days
  Frozen  14 days
  Ambient  7 days

Reject Due To

Hemolysis

Mild OK; Gross OK

Lipemia

Mild OK; Gross OK

Icterus

Mild OK; Gross OK

Other

NA

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).

Cautions

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.

 

Fibrinogen will migrate as a distinct band in the beta-gamma-fraction. Serum samples 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. 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

Monday through Saturday; Continuously until 2 p.m.

Analytic Time

Same day/1 day

Performing Laboratory

Mayo Clinic Laboratories in Rochester

Test Classification

See Individual Test IDs

CPT 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

NY State Approved

Yes