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Test Code QMPSS Monoclonal Protein Study, Quantitative, Serum


Ordering Guidance


 



Additional Testing Requirements


Quantitation of monoclonal protein alone is not considered an adequate screen for monoclonal gammopathies. When screening a patient or establishing a first-time diagnosis for a monoclonal gammopathy, order FLCS / Immunoglobulin Free Light Chains, Serum in addition to this test.



Specimen Required


Supplies: Sarstedt Aliquot Tube, 5 mL (T914)

Collection Container/Tube:

Preferred: Serum gel

Acceptable: Red top

Submission Container/Tube: Plastic vial

Specimen Volume: 2 mL total in 2 separate plastic vials, each containing 1 mL

Collection Instructions: Centrifuge and aliquot serum into 2 plastic vials, each containing 1 mL


Secondary ID

620919

Useful For

Aiding in the diagnosis and monitoring of monoclonal gammopathies, when used in conjunction with free light chain studies

 

This test alone is not considered an adequate screen for monoclonal gammopathies.

Profile Information

Test ID Reporting Name Available Separately Always Performed
QMPTS Quantitative M-protein Isotype, S No Yes
IGA Immunoglobulin A (IgA), S Yes, (Order IMMG or IGA) Yes
IGM Immunoglobulin M (IgM), S Yes, (Order IMMG or IGM) Yes
IGG Immunoglobulin G (IgG), S Yes, (Order IMMG or IGG) Yes
TMAB1 Therapeutic Antibody Administered? No Yes

Reflex Tests

Test ID Reporting Name Available Separately Always Performed
IFXED Immunofixation Delta and Epsilon, S Yes No
IGD Immunoglobulin D (IgD), S Yes No
IGE Immunoglobulin E (IgE), S Yes No

Testing Algorithm

This test includes quantitation of monoclonal-protein isotype and immunoglobulins G, A, and M.

 

If a light chain is identified without a corresponding heavy chain during initial testing, then immunofixation with immunoglobulin D (IgD) and immunoglobulin E (IgE) will be performed at an additional charge.

 

If a monoclonal IgD or IgE is identified during initial testing, then IgD or IgE testing will be performed at an additional charge.

 

For more information see:

-Multiple Myeloma: Laboratory Screening

-Amyloidosis: Laboratory Approach to Diagnosis

-Acquired Neuropathy Diagnostic Algorithm

Method Name

QMPTS: Matrix-Assisted Laser Desorption/Ionization Time-of-Flight Mass Spectrometry (MALDI-TOF MS)

IGG, IGA, IGM: Nephelometry

TMAB1: Patient Information

Reporting Name

Quantitative M-protein Study, S

Specimen Type

Serum

Specimen Minimum Volume

1.5 mL

Specimen Stability Information

Specimen Type Temperature Time Special Container
Serum Refrigerated (preferred) 28 days
  Frozen  28 days
  Ambient  7 days

Reject Due To

Gross hemolysis OK
Gross lipemia Reject
Gross icterus OK

Reference Values

Monoclonal-protein Isotype Flag:

Negative

Interpretation:

No monoclonal protein detected.

 

IgG:

0-<5 months: 100-334 mg/dL

5-<9 months: 164-588 mg/dL

9-<15 months: 246-904 mg/dL

15-<24 months: 313-1,170 mg/dL

2-<4 years: 295-1,156 mg/dL

4-<7 years: 386-1,470 mg/dL

7-<10 years: 462-1,682 mg/dL

10-<13 years: 503-1,719 mg/dL

13-<16 years: 509-1,580 mg/dL

16-<18 years: 487-1,327 mg/dL

≥18 years: 767-1,590 mg/dL

 

IgA:

0-<5 months: 7-37 mg/dL

5-<9 months: 16-50 mg/dL

9-<15 months: 27-66 mg/dL

15-<24 months: 36-79 mg/dL

2-<4 years: 27-246 mg/dL

4-<7 years: 29-256 mg/dL

7-<10 years: 34-274 mg/dL

10-<13 years: 42-295 mg/dL

13-<16 years: 52-319 mg/dL

16-<18 years: 60-337 mg/dL

≥18 years: 61-356 mg/dL

 

IgM:

0-<5 months: 26-122 mg/dL

5-<9 months: 32-132 mg/dL

9-<15 months: 40-143 mg/dL

15-<24 months: 46-152 mg/dL

2-<4 years: 37-184 mg/dL

4-<7 years: 37-224 mg/dL

7-<10 years: 38-251 mg/dL

10-<13 years: 41-255 mg/dL

13-<16 years: 45-244 mg/dL

16-<18 years: 49-201 mg/dL

≥18 years: 37-286 mg/dL

Method Description

Monoclonal protein isotype by matrix-assisted laser desorption/ionization time-of-flight mass spectrometry (MALDI-TOF MS) is performed with immunoaffinity purification followed by MALDI-TOF MS analysis. For the immunoaffinity purification, patient serum is applied to 5 separate immunoaffinity resins specific to immunoglobulins G, A, M, K, and L. Unbound protein is washed away and the isolated immunoglobulins are broken down in to their reduced to separate the heavy and light chains subunits to be analyzed via MALDI-TOF MS. The 5 separate spectra from each specimen immunopurification are overlaid and investigated for an overabundance of immunoglobulin and immunoglobulin light chain. Monoclonal protein peaks are integrated based on the modeled polyclonal background. The quantitative value is determined based on the percent area and nephelometric value of the corresponding immunoglobulin.(Milani P, Murray DL, Barnidge DR, et al. The utility of MASS-FIX to detect and monitor monoclonal proteins in the clinic. Am J Hematol. 2017;92(8):772-779. doi:10.1002/ajh.24772)

Day(s) Performed

Monday through Friday

Report Available

2 to 4 days

Performing Laboratory

Mayo Clinic Laboratories in Rochester

Test Classification

This test was developed and its performance characteristics determined by Mayo Clinic in a manner consistent with CLIA requirements. It has not been cleared or approved by the US Food and Drug Administration.

CPT Code Information

0077U

82784 x 3

LOINC Code Information

Test ID Test Order Name Order LOINC Value
QMPSS Quantitative M-protein Study, S 104266-2

 

Result ID Test Result Name Result LOINC Value
TMAB1 Therapeutic Antibody Administered? 98855-0
IGA Immunoglobulin A (IgA), S 2458-8
IGG Immunoglobulin G (IgG), S 2465-3
IGM Immunoglobulin M (IgM), S 2472-9
620875 M-protein GK 74862-4
620876 M-protein GL 74863-2
620877 M-protein AK 74864-0
620878 M-protein AL 74865-7
620879 M-protein MK 74866-5
620880 M-protein ML 74867-3
620881 Glycosylation 104267-0
620874 Flag, M-protein Isotype 94400-9
621012 QMPTS Interpretation 69048-7

Forms

If not ordering electronically, complete, print, and send 1 of the following forms with the specimen:

-Hematopathology/Cytogenetics Test Request (T726)

-Renal Diagnostics Test Request (T830)

-General Request (T239)