What type of study is this?

This is a Quantitative Study study.

October 3, 2025Clinical ChemistryOpen Access

B-348 M protein cut-off for initial evaluation of monoclonal gammopathies with the Immunglobulin Isotypes (GAM) for the EXENT® analyzer MALDI-ToF assay

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Study establishes cut-off concentrations for M proteins in patients suspected of monoclonal gammopathy, indicating reliable diagnostic criteria.

Population-based clinical cut-off values for M proteins were validated, improving diagnostic accuracy.
Of 364 subjects, 216 (59.3%) tested positive for M proteins; the cut-offs were 0.359 g/L for IgG, 0.325 g/L for IgA, and 0.227 g/L for IgM.
The MALDI-ToF assay showed 85% agreement with traditional immunofixation electrophoresis, highlighting its potential reliability.
Using these cut-offs may prevent unnecessary investigations and reduce the risk of overdiagnosis of MGUS.

Lakos et al. (2025) studied this question.

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Study establishes cut-off concentrations for M proteins in patients suspected of monoclonal gammopathy, indicating reliable diagnostic criteria.