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Clinical Chemistry and Laboratory Medicine (CCLM)

Published in Association with the European Federation of Clinical Chemistry and Laboratory Medicine (EFLM)

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Retrospective study of monoclonal gammopathies detected in the clinical laboratory of a Spanish healthcare district: 14-year series

Enrique Bergón1 / Elena Miravalles2



Corresponding author: Enrique Bergón, Department of Biochemistry, Hospital Universitario de Getafe, Cta. Toledo, km 12,500, 28905 Getafe, Madrid, Spain Phone: +34-91-6839360, Fax: +34-91-6839748,

Citation Information: Clinical Chemical Laboratory Medicine. Volume 45, Issue 2, Pages 190–196, ISSN (Online) 1437-4331, ISSN (Print) 1434-6621, DOI: 10.1515/CCLM.2007.029, February 2007

Publication History

September 18, 2006
October 31, 2006
Published Online:


Background: We studied the incidence, classification and isotype distribution of monoclonal gammopathies and M-protein detected between 1992 and 2005 inclusive in the clinical laboratory of a healthcare district in Madrid (Spain) with an average population of 280,574 inhabitants.

Methods: Serum electrophoresis was carried out on a cellulose acetate support up until 1997, and then using capillary zone electrophoresis systems, with M-protein identification carried out by agarose gel immunofixation. The age-adjusted incidences were standardized with respect to the WHO World Standard Population Distribution, based on the world average population between 2000 and 2025. The clinical diagnosis was recorded from the patient case history.

Results: M-protein was detected in a total of 537 patients; of these, 42 had been diagnosed before 1992, representing a 0.19% prevalence in our population. The mean age-adjusted incidence of monoclonal gammopathy was 10.72 per 100,000 inhabitants/year (SE 1.31), ranging from 4.85/100,000 in 1992 to 14.28/100,000 in 2003 and 2004. The median patient age at diagnosis was 73 years (range 25–96 years), with males accounting for 46.8% of all cases of monoclonal gammopathy, and 57.8% of all malignant monoclonal gammopathies. A total of 54.1% of the patients were clinically defined as presenting monoclonal gammopathy of undetermined significance, 31.3% presented multiple myeloma, and the remaining 14.6% presented malignant gammopathies. The most frequent M-protein isotype was IgG (55.8%), followed by IgA (20.8%) and IgM (13.6%). A total of 88% of the light chain M-proteins, 54% of isotype IgM, 51% of isotype IgA and 36% of isotype IgG were associated with B lymphoproliferative diseases.

Conclusions: We conclude that the clinical laboratory should play an important role in the study of monoclonal gammopathies, since it is the only location where all M-protein patients are observed. On the other hand, studies of this type should be carried out over long-term periods, owing to the variations we have noted in the detection of M-proteins.

Clin Chem Lab Med 2007;45:190–6.

Keywords: classification of monoclonal gammopathies; incidence; M-protein isotype distribution; prevalence

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