{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,24]],"date-time":"2026-10-24T11:58:18Z","timestamp":1792843098417,"version":"4.5.0"},"reference-count":19,"publisher":"Walter de Gruyter GmbH","issue":"4","license":[{"start":{"date-parts":[[2020,1,15]],"date-time":"2020-01-15T00:00:00Z","timestamp":1579046400000},"content-version":"unspecified","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by\/4.0"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[2020,3,26]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:sec id=\"j_cclm-2019-1105_s_999\">\n                    <jats:title>Background<\/jats:title>\n                    <jats:p>Electrophoretic methods to detect, characterize and quantify M-proteins play an important role in the management of patients with monoclonal gammopathies (MGs). Significant uncertainty in the quantification and limit of detection (LOD) is documented when M-proteins are &lt;10 g\/L. Using spiked sera, we aimed to assess the variability in intact M-protein quantification and LOD across 16 laboratories.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec id=\"j_cclm-2019-1105_s_998\">\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>Sera with normal, hypo- or hyper-gammaglobulinemia were spiked with daratumumab or elotuzumab, with concentrations from 0.125 to 10 g\/L (n\u2009=\u200962) along with a beta-migrating sample (n\u2009=\u20099). Laboratories blindly analyzed samples according to their serum protein electrophoresis (SPEP)\/isotyping standard operating procedures. LOD and intra-laboratory percent coefficient of variation (%CV) were calculated and further specified with regard to the method (gel\/capillary electrophoresis [CZE]), gating strategy (perpendicular drop [PD]\/tangent skimming [TS]), isotyping (immunofixation\/immunosubtraction [ISUB]) and manufacturer (Helena\/Sebia).<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec id=\"j_cclm-2019-1105_s_997\">\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>All M-proteins \u22651 g\/L were detected by SPEP. With isotyping the LOD was moderately more sensitive than with SPEP. The intensity of polyclonal background had the biggest negative impact on LOD. Independent of the method used, the intra-laboratory imprecision of M-protein quantification was small (mean CV\u2009=\u20095.0%). Low M-protein concentration and high polyclonal background had the strongest negative impact on intra-laboratory precision. All laboratories were able to follow trend of M-protein concentrations down to 1 g\/L.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec id=\"j_cclm-2019-1105_s_996\">\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>In this study, we describe a large variation in the reported LOD for both SPEP and isotyping; overall LOD is most affected by the polyclonal immunoglobulin background. Satisfactory intra-laboratory precision was demonstrated. This indicates that the quantification of small M-proteins to monitor patients over time is appropriate, when subsequent testing is performed within the same laboratory.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1515\/cclm-2019-1105","type":"journal-article","created":{"date-parts":[[2020,1,15]],"date-time":"2020-01-15T04:02:47Z","timestamp":1579060967000},"page":"547-559","source":"Crossref","is-referenced-by-count":70,"title":["An international multi-center serum protein electrophoresis accuracy and M-protein isotyping study. Part II: limit of detection and follow-up of patients with small M-proteins"],"prefix":"10.1515","volume":"58","author":[{"given":"Joannes F.M.","family":"Jacobs","sequence":"first","affiliation":[{"name":"Laboratory Medical Immunology, Department of Laboratory Medicine , Radboud University Medical Center , Geert Grooteplein 10 , 6525 GA Nijmegen , The Netherlands"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Katherine A.","family":"Turner","sequence":"additional","affiliation":[{"name":"Department of Laboratory Medicine and Pathology , Mayo Clinic , Rochester , MN , USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Maria Stella","family":"Graziani","sequence":"additional","affiliation":[{"name":"Section of Clinical Biochemistry , University of Verona , Verona , Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jody L.","family":"Frinack","sequence":"additional","affiliation":[{"name":"Department of Laboratory Medicine and Pathology , Mayo Clinic , Rochester , MN , USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Michael W.","family":"Ettore","sequence":"additional","affiliation":[{"name":"Department of Laboratory Medicine and Pathology , Mayo Clinic , Rochester , MN , USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jillian R.","family":"Tate","sequence":"additional","affiliation":[{"name":"Department of Chemical Pathology , Pathology Queensland, Royal Brisbane and Women\u2019s Hospital , Brisbane , QLD , Australia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ronald A.","family":"Booth","sequence":"additional","affiliation":[{"name":"Department of Pathology and Laboratory Medicine , The Ottawa Hospital , Ottawa , ON , Canada"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Christopher R.","family":"McCudden","sequence":"additional","affiliation":[{"name":"Department of Pathology and Laboratory Medicine , The Ottawa Hospital , Ottawa , ON , Canada"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"David F.","family":"Keren","sequence":"additional","affiliation":[{"name":"Department of Pathology , The University of Michigan , Ann Arbor , MI , USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Julio C.","family":"Delgado","sequence":"additional","affiliation":[{"name":"ARUP Laboratories, Department of Pathology , University of Utah School of Medicine , Salt Lake City , UT , USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Galina","family":"Zemtsovskaja","sequence":"additional","affiliation":[{"name":"Clinical Chemistry Laboratory , North Estonia Medical Centre , Tallinn , Estonia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Robert O.","family":"Fullinfaw","sequence":"additional","affiliation":[{"name":"Department of Chemical Pathology , The Royal Melbourne Hospital , Melbourne, Victoria , Australia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Anna","family":"Caldini","sequence":"additional","affiliation":[{"name":"General Laboratory , Careggi University Hospital , Florence , Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Theo","family":"de Malmanche","sequence":"additional","affiliation":[{"name":"NSW Health Pathology, Immunology Department , John Hunter Hospital , New Lambton Heights NSW , Australia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Katina","family":"Katakouzinos","sequence":"additional","affiliation":[{"name":"Immunopathology Department , Royal Prince Alfred Hospital , Camperdown , NSW , Australia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Matthew","family":"Burke","sequence":"additional","affiliation":[{"name":"Department of Chemical Pathology , Pathology Queensland, Royal Brisbane and Women\u2019s Hospital , Brisbane , QLD , Australia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Giovanni","family":"Palladini","sequence":"additional","affiliation":[{"name":"Amyloidosis Research and Treatment Center, Foundation IRCCS Policlinico San Matteo, and Department of Molecular Medicine, University of Pavia , Pavia , Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sara","family":"Altinier","sequence":"additional","affiliation":[{"name":"Laboratory Medicine of the University Hospital of Padova , Padova , Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Martina","family":"Zaninotto","sequence":"additional","affiliation":[{"name":"Laboratory Medicine of the University Hospital of Padova , Padova , Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Gabriella","family":"Righetti","sequence":"additional","affiliation":[{"name":"Clinical Chemistry Laboratory , University of Verona , Verona , 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