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

Author:

Keren David F.12,Bocsi Gregary3,Billman Brooke L.4,Etzell Joan5,Faix James D.6,Kumar Shaji7,Lipe Brea8,McCudden Christopher9,Montgomery Roberta10,Murray David L.11,Rai Alex J.12,Redondo Teresita Cuyegkeng13,Souter Lesley14,Ventura Christina B.15,Ansari Mohammad Qasim162

Affiliation:

1. From the Department of Pathology, Michigan Medicine University of Michigan, Ann Arbor (Keren)

2. Keren and Ansari served as guideline cochairs

3. the Department of Pathology, University of Colorado Anschutz, Aurora (Bocsi)

4. Governance Services (Billman)

5. the Department of Pathology, Sutter Health Shared Laboratory, Livermore, California (Etzell)

6. the Department of Pathology, Montefiore Medical Center, Bronx, New York (Faix)

7. the Department of Internal Medicine, Mayo Clinic, Rochester, Minnesota (Kumar)

8. the Department of Medicine, University of Rochester Medical Center, Rochester, New York (Lipe)

9. the Department of Pathology and Laboratory Medicine, The Ottawa Hospital, Ottawa, Ontario, Canada (McCudden)

10. Retired, Mundelein, Illinois (Montgomery)

11. the Department of Pathology, PeaceHealth Southwest Medical Center, Vancouver, Washington (Murray)

12. the Department of Pathology and Cell Biology, Columbia University Medical Center, New York, New York (Rai)

13. the Department of Pathology, Saint Barnabas Medical Center, Livingston, New Jersey (Redondo)

14. Methodology Consultant, Hamilton, Ontario, Canada (Souter)

15. Surveys (Ventura), College of American Pathologists, Northfield, Illinois

16. the Department of Pathology and Laboratory Medicine, Louis Stokes Veterans Affairs Medical Center, Cleveland, Ohio (Ansari)

Abstract

Context.— The process for identifying patients with monoclonal gammopathies is complex. Initial detection of a monoclonal immunoglobulin protein (M protein) in the serum or urine often requires compilation of analytical data from several areas of the laboratory. The detection of M proteins depends on adequacy of the sample provided, available clinical information, and the laboratory tests used. Objective.— To develop an evidence-based guideline for the initial laboratory detection of M proteins. Design.— To develop evidence-based recommendations, the College of American Pathologists convened a panel of experts in the diagnosis and treatment of monoclonal gammopathies and the laboratory procedures used for the initial detection of M proteins. The panel conducted a systematic literature review to address key questions. Using the Grading of Recommendations Assessment, Development, and Evaluation approach, recommendations were created based on the available evidence, strength of that evidence, and key judgements as defined in the Grading of Recommendations Assessment, Development, and Evaluation Evidence to Decision framework. Results.— Nine guideline statements were established to optimize sample selection and testing for the initial detection and quantitative measurement of M proteins used to diagnose monoclonal gammopathies. Conclusions.— This guideline was constructed to harmonize and strengthen the initial detection of an M protein in patients displaying symptoms or laboratory features of a monoclonal gammopathy. It endorses more comprehensive initial testing when there is suspicion of amyloid light chain amyloidosis or neuropathies, such as POEMS (polyneuropathy, organomegaly, endocrinopathy, M protein, and skin changes) syndrome, associated with an M protein.

Publisher

Archives of Pathology and Laboratory Medicine

Subject

Medical Laboratory Technology,General Medicine,Pathology and Forensic Medicine

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