{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,28]],"date-time":"2026-09-28T22:06:02Z","timestamp":1790633162686,"version":"4.1.0"},"reference-count":37,"publisher":"Walter de Gruyter GmbH","issue":"4","content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[2026,3,26]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:sec id=\"j_cclm-2025-0894_abs_001\">\n                    <jats:title>Objectives<\/jats:title>\n                    <jats:p>\n                      This study aimed to perform an extended analytical verification of the Immunoglobulin Isotypes (GAM) for the EXENT\n                      <jats:sup>\u00ae<\/jats:sup>\n                      Analyzer (EXENT\n                      <jats:sup>\u00ae<\/jats:sup>\n                      -GAM) assay, a MALDI-TOF mass spectrometry-based method for detecting and quantifying serum M-proteins in patients with plasma cell dyscrasias, and to compare it with conventional serum protein electrophoresis (SPEP), serum immunofixation electrophoresis (sIFE) and serum free light chains (sFLC) assays.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec id=\"j_cclm-2025-0894_abs_002\">\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>Imprecision, linearity, limit of quantification (LOQ), quantification comparison with SPEP, isotyping concordance with sIFE and sFLC, interference from therapeutic monoclonal antibodies (t-mAbs), sample stability, and reagent lot consistency were evaluated.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec id=\"j_cclm-2025-0894_abs_003\">\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>\n                      EXENT\n                      <jats:sup>\u00ae<\/jats:sup>\n                      -GAM demonstrated acceptable imprecision (CV\u00a0\u226420\u202f% for low and\u00a0\u226415\u202f% for high M-protein levels) and wide linear range (\u223c0.03\u201330\u202fg\/L). The polyclonal immunoglobulin background negatively influenced the assays LOQ. M-proteins with mass-shifted light chains (i.e.,\u00a0glycosylated light chains) are prone to non-linearity and inferior LOQ. M-protein quantification by EXENT\n                      <jats:sup>\u00ae<\/jats:sup>\n                      differed systematically and proportionally from quantification by SPEP, highlighting non-interchangeability. EXENT\n                      <jats:sup>\u00ae<\/jats:sup>\n                      demonstrated 97\u202f% concordance with sIFE for M-protein isotyping and identified numerous additional (low-level) M-proteins. Some proved to be clinically relevant (residual disease in sIFE-negative samples); others lacked correlation with sFLC result or clinical diagnosis. EXENT\n                      <jats:sup>\u00ae<\/jats:sup>\n                      reliably distinguished endogenous M-proteins from t-mAbs, except talquetamab, which interfered with quantification and was partially misclassified.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec id=\"j_cclm-2025-0894_abs_004\">\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>\n                      EXENT\n                      <jats:sup>\u00ae<\/jats:sup>\n                      -GAM enables sensitive and reproducible quantification and isotyping of M-proteins below the detection limit of SPEP and sIFE. Its ability to resolve analytical challenges posed by SPEP and sIFE represents a significant advancement. Further clinical studies are needed to confirm its potential in residual disease detection.\n                    <\/jats:p>\n                  <\/jats:sec>","DOI":"10.1515\/cclm-2025-0894","type":"journal-article","created":{"date-parts":[[2025,12,2]],"date-time":"2025-12-02T09:56:44Z","timestamp":1764669404000},"page":"922-931","source":"Crossref","is-referenced-by-count":3,"title":["Extended verification of an automated MALDI-TOF mass spectrometry system for high throughput serum M-protein measurement"],"prefix":"10.1515","volume":"64","author":[{"given":"Louis","family":"Nevejan","sequence":"first","affiliation":[{"name":"Department of Laboratory Medicine , AZ Sint-Jan Hospital Brugge , Bruges , Belgium"},{"name":"Department of Microbiology, Immunology and Transplantation, Clinical and Diagnostic Immunology , KU Leuven , Leuven , Belgium"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jan","family":"Van Droogenbroeck","sequence":"additional","affiliation":[{"name":"Department of Hematology , AZ St-Jan Hospital Brugge , Bruges , Belgium"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Emile","family":"Van Hecke","sequence":"additional","affiliation":[{"name":"Department of Laboratory Medicine , AZ Sint-Jan Hospital Brugge , Bruges , Belgium"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Alexander","family":"Schauwvlieghe","sequence":"additional","affiliation":[{"name":"Department of Hematology , AZ St-Jan Hospital Brugge , Bruges , Belgium"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Michel R.","family":"Langlois","sequence":"additional","affiliation":[{"name":"Department of Laboratory Medicine , AZ Sint-Jan Hospital Brugge , Bruges , Belgium"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-6856-8485","authenticated-orcid":false,"given":"Xavier","family":"Bossuyt","sequence":"additional","affiliation":[{"name":"Department of Microbiology, Immunology and Transplantation, Clinical and Diagnostic Immunology , KU Leuven , Leuven , Belgium"},{"name":"Department of Laboratory Medicine , University Hospitals Leuven , Leuven , Belgium"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Martine","family":"Vercammen","sequence":"additional","affiliation":[{"name":"Department of Laboratory Medicine , AZ Sint-Jan Hospital Brugge , Bruges , Belgium"},{"name":"Observational Clinical Sciences , Vrije Universiteit Brussel , Brussels , Belgium"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"374","published-online":{"date-parts":[[2025,12,3]]},"reference":[{"key":"2026051215455623232_j_cclm-2025-0894_ref_001","unstructured":"Tate, JR. 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