{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,24]],"date-time":"2026-10-24T11:58:17Z","timestamp":1792843097902,"version":"4.5.0"},"reference-count":21,"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-2019-1104_s_999\">\n                    <jats:title>Background<\/jats:title>\n                    <jats:p>Serum protein electrophoresis (SPEP) is used to quantify the serum monoclonal component or M-protein, for diagnosis and monitoring of monoclonal gammopathies. Significant imprecision and inaccuracy pose challenges in reporting small M-proteins. Using therapeutic monoclonal antibody-spiked sera and a pooled beta-migrating M-protein, we aimed to assess SPEP limitations and variability across 16 laboratories in three continents.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec id=\"j_cclm-2019-1104_s_998\">\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>Sera with normal, hypo- or hypergammaglobulinemia were spiked with daratumumab, Dara (cathodal migrating), or elotuzumab, Elo (central-gamma migrating), with concentrations from 0.125 to 10 g\/L (n\u2009=\u200962) along with a beta-migrating sample (n\u2009=\u20099). Provided with total protein (reverse biuret, Siemens), laboratories blindly analyzed samples according to their SPEP and immunofixation (IFE) or immunosubtraction (ISUB) standard operating procedures. Sixteen laboratories reported the perpendicular drop (PD) method of gating the M-protein, while 10 used tangent skimming (TS). A mean percent recovery range of 80%\u2013120% was set as acceptable. The inter-laboratory %CV was calculated.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec id=\"j_cclm-2019-1104_s_997\">\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>Gamma globulin background, migration pattern and concentration all affect the precision and accuracy of quantifying M-proteins by SPEP. As the background increases, imprecision increases and accuracy decreases leading to overestimation of M-protein quantitation especially evident in hypergamma samples, and more prominent with PD. Cathodal migrating M-proteins were associated with less imprecision and higher accuracy compared to central-gamma migrating M-proteins, which is attributed to the increased gamma background contribution in M-proteins migrating in the middle of the gamma fraction. There is greater imprecision and loss of accuracy at lower M-protein concentrations.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec id=\"j_cclm-2019-1104_s_996\">\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>This study suggests that quantifying exceedingly low concentrations of M-proteins, although possible, may not yield adequate accuracy and precision between laboratories.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1515\/cclm-2019-1104","type":"journal-article","created":{"date-parts":[[2020,1,15]],"date-time":"2020-01-15T04:02:47Z","timestamp":1579060967000},"page":"533-546","source":"Crossref","is-referenced-by-count":68,"title":["An international multi-center serum protein electrophoresis accuracy and M-protein isotyping study. Part I: factors impacting limit of quantitation of serum protein electrophoresis"],"prefix":"10.1515","volume":"58","author":[{"given":"Katherine A.","family":"Turner","sequence":"first","affiliation":[{"name":"Department of Laboratory Medicine and Pathology , Mayo Clinic , Rochester , MN , USA"}],"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":"Maria Stella","family":"Graziani","sequence":"additional","affiliation":[{"name":"Section of Clinical Biochemistry , University of Verona , Verona , Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Joannes F.M.","family":"Jacobs","sequence":"additional","affiliation":[{"name":"Department of Laboratory Medicine , Radboud University Medical Center, Laboratory Medical Immunology , Nijmegen , the Netherlands"}],"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":"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 , Missenden Rd , 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 , Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Marie Therese","family":"Melki","sequence":"additional","affiliation":[{"name":"Sebia Inc. , Lisses , France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Stephen","family":"Bell","sequence":"additional","affiliation":[{"name":"Helena Biosciences Europe , Gateshead , UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Maria Alice Vieira","family":"Willrich","sequence":"additional","affiliation":[{"name":"Division of Clinical Biochemistry and Immunology, Department of Laboratory Medicine and Pathology , Mayo Clinic , 200 First Street SW , Rochester, MN 55905 , USA"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"374","published-online":{"date-parts":[[2020,1,15]]},"reference":[{"key":"2023033111570862154_j_cclm-2019-1104_ref_001","unstructured":"Katzmann JA. 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