TY - JOUR
T1 - Laboratory Detection and Initial Diagnosis of Monoclonal Gammopathies
T2 - Guideline From the College of American Pathologists in Collaboration With the American Association for Clinical Chemistry and the American Society for Clinical Pathology
AU - Keren, David F.
AU - Bocsi, Gregary
AU - Billman, Brooke L.
AU - Etzell, Joan
AU - Faix, James D.
AU - Kumar, Shaji
AU - Lipe, Brea
AU - McCudden, Christopher
AU - Montgomery, Roberta
AU - Murray, David L.
AU - Rai, Alex J.
AU - Redondo, Teresita Cuyegkeng
AU - Souter, Lesley
AU - Ventura, Christina B.
AU - Ansari, Mohammad Qasim
N1 - Publisher Copyright:
© 2022 College of American Pathologists. All rights reserved.
PY - 2022/5
Y1 - 2022/5
N2 - 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.
AB - 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.
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U2 - 10.5858/arpa.2020-0794-CP
DO - 10.5858/arpa.2020-0794-CP
M3 - Review article
C2 - 34347866
AN - SCOPUS:85129344894
SN - 0003-9985
VL - 146
SP - 575
EP - 590
JO - Archives of Pathology and Laboratory Medicine
JF - Archives of Pathology and Laboratory Medicine
IS - 5
ER -