Laboratory Detection and Initial Diagnosis of Monoclonal Gammopathies
Publication Date: August 4, 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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- IFE: Immunofixation Electrophoresis
- IgA: Immunoglobulin A
- IgG: Immunoglobulin G
- IgM: Immunoglobulin M
- MM: Multiple Myeloma
- SPE: Serum Protein Electrophoresis
Title
Laboratory Detection and Initial Diagnosis of Monoclonal Gammopathies
Authoring Organizations
American Association for Clinical Chemistry
American Society for Clinical Pathology
College of American Pathologists
Publication Month/Year
August 4, 2021
Last Updated Month/Year
July 14, 2023
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.
Methodology
Number of Source Documents
104
Literature Search Start Date
January 31, 2018
Literature Search End Date
January 29, 2019