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Test ID MPSS Monoclonal Protein Study, Serum

Reporting Name

Monoclonal Protein Study, S

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

Includes total protein, serum protein electrophoresis (SPEP), heavy chain 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

Specimen Type

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
Serum Refrigerated (preferred) 14 days
  Ambient  14 days
  Frozen  14 days

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 Saturday; 2 p.m.

Test Classification

This test has been cleared or approved 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-Protein, total

84165-Protein electrophoresis

86334-Immunofixation

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 12851-2

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:

-Laboratory Approach to the Diagnosis of Amyloidosis

-Laboratory Screening Tests for Suspected Multiple Myeloma

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 >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 / Monoclonal Protein Study, 24 Hour, 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 / 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 / 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 / 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

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 day

Method Name

TPE: Biuret

ELP: Agarose Gel Electrophoresis

IMFX: Immunofixation