Recommendations for the study of monoclonal gammopathies in the clinical laboratory. A consensus of the Spanish Society of Laboratory Medicine and the Spanish Society of Hematology and Hemotherapy. Part I: Update on laboratory tests for the study of monoclonal gammopathies

Clin Chem Lab Med. 2023 Jul 24;61(12):2115-2130. doi: 10.1515/cclm-2023-0326. Print 2023 Nov 27.

Abstract

Monoclonal gammopathies (MG) are characterized by the proliferation of plasma cells that produce identical abnormal immunoglobulins (intact or some of their subunits). This abnormal immunoglobulin component is called monoclonal protein (M-protein), and is considered a biomarker of proliferative activity. The identification, characterization and measurement of M-protein is essential for the management of MG. We conducted a systematic review of the different tests and measurement methods used in the clinical laboratory for the study of M-protein in serum and urine, the biochemistry and hematology tests necessary for clinical evaluation, and studies in bone marrow, peripheral blood and other tissues. This review included literature published between 2009 and 2022. The paper discusses the main methodological characteristics and limitations, as well as the purpose and clinical value of the different tests used in the diagnosis, prognosis, monitoring and assessment of treatment response in MG. Included are methods for the study of M-protein, namely electrophoresis, measurement of immunoglobulin levels, serum free light chains, immunoglobulin heavy chain/light chain pairs, and mass spectrometry, and for the bone marrow examination, morphological analysis, cytogenetics, molecular techniques, and multiparameter flow cytometry.

Keywords: bone marrow; electrophoresis, capillary; immunofixation; in situ hybridization, fluorescence; monoclonal gammopathy of undetermined significance; multiple myeloma.

Publication types

  • Systematic Review

MeSH terms

  • Consensus
  • Hematology*
  • Humans
  • Immunoglobulin Light Chains
  • Laboratories, Clinical
  • Multiple Myeloma* / diagnosis
  • Paraproteinemias* / diagnosis
  • Paraproteinemias* / therapy

Substances

  • Immunoglobulin Light Chains