Laboratory Detection and Initial Diagnosis of Monoclonal Gammopathies

Publication Date: August 3, 2021
Last Updated: March 14, 2022

Summary of Recommendations

Clinical care providers should order both serum protein electrophoresis (SPEP) and serum free light chains (sFLC) for the initial detection of monoclonal immunoglobulin protein (M-protein) in all patients with suspected monoclonal gammopathies (MG). ( S )
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Laboratorians should confirm a SPEP abnormality suspicious for a presence of a M-protein with additional testing by serum immunofixation electrophoresis (sIFE) or alternative method with similar sensitivity. ( S )
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Laboratorians and/or clinical care providers should follow-up an abnormal sFLC ratio for the presence of a M-protein with a serum IFE or alternative method with similar sensitivity. ( C )
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Clinical care providers should order SPEP, sFLC, serum IFE, and urine IFE for the initial detection of M-protein in all patients with suspected amyloid light chain (AL) amyloidosis. ( S )
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Clinical care providers should not order heavy /light chain isotype assay (hlc) for initial detection of m-protein in patients with suspected mg. ( S )
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Clinical care providers should not use total/intact light chains for the quantitation of m-proteins in patients with suspected myeloma. ( S )
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In patients with intact M-proteins outside the gamma region by SPEP, laboratories should use total immunoglobulin (IgA, IgG, or IgM) for the quantitation of the M-proteins; quantitation of a band in the beta region by SPEP can be performed if the M-protein is distinguished from background normal protein bands. ( C )
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Laboratorians should report both quantitative levels of free kappa and free lambda and the rFLC when the sFLC assay is performed. ( S )
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Clinical care providers may use rFLC, IgM isotype, M-protein >1.5 g/dL, and immunoparesis as risk factors for progression to MM or a B-cell lymphoproliferative disorder ( C )
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Recommendation Grading

Abbreviations

  • IFE: Immunofixation Electrophoresis
  • IgA: Immunoglobulin A
  • IgG: Immunoglobulin G
  • IgM: Immunoglobulin M
  • MM: Multiple Myeloma
  • SPE: Serum Protein Electrophoresis

Overview

Title

Laboratory Detection and Initial Diagnosis of Monoclonal Gammopathies

Authoring Organizations

Association for Diagnostics & Laboratory Medicine

American Society for Clinical Pathology

College of American Pathologists

Publication Month/Year

August 3, 2021

Last Updated Month/Year

April 1, 2024

Supplemental Implementation Tools

Document Type

Guideline

Country of Publication

US

Inclusion Criteria

Male, Female, Adolescent, Adult, Child, Infant, Older adult

Health Care Settings

Laboratory services

Intended Users

Clinical researcher, laboratory technician, medical techologist technician, nurse, nurse practitioner, physician, physician assistant

Scope

Diagnosis, Assessment and screening

Diseases/Conditions (MeSH)

D000911 - Antibodies, Monoclonal, D010336 - Pathology, D008998 - Monoclonal Gammopathy of Undetermined Significance

Keywords

Gammopathies, Monoclonal Gammopathies, M proteins

Source Citation

Keren DF, Bocsi G, Billman BL, Etzell J, Faix JD, Kumar S, Lipe B, McCudden C, Montgomery R, Murray DL, Rai AJ, Redondo TC, Souter L, Ventura CB, Ansari MQ. Laboratory Detection and Initial Diagnosis of Monoclonal Gammopathies: Guideline From the College of American Pathologists in Collaboration With the American Association for Clinical Chemistry and the American Society for Clinical Pathology. Arch Pathol Lab Med. 2021 Aug 4. doi: 10.5858/arpa.2020-0794-CP. Epub ahead of print. PMID: 34347866.

Supplemental Methodology Resources

Evidence Tables, Methodology Supplement, Data Supplement

Methodology

Number of Source Documents
104
Literature Search Start Date
January 30, 2018
Literature Search End Date
January 28, 2019