{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,5,12]],"date-time":"2026-05-12T15:08:55Z","timestamp":1778598535694,"version":"3.51.4"},"reference-count":37,"publisher":"Walter de Gruyter GmbH","issue":"7","license":[{"start":{"date-parts":[[2025,3,21]],"date-time":"2025-03-21T00:00:00Z","timestamp":1742515200000},"content-version":"unspecified","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by\/4.0"}],"funder":[{"DOI":"10.13039\/100000050","name":"National Heart, Lung, and Blood Institute","doi-asserted-by":"publisher","award":["R01 HL150146"],"award-info":[{"award-number":["R01 HL150146"]}],"id":[{"id":"10.13039\/100000050","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/501100003196","name":"Ministero della Salute","doi-asserted-by":"publisher","award":["Ricerca Corrente"],"award-info":[{"award-number":["Ricerca Corrente"]}],"id":[{"id":"10.13039\/501100003196","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[2025,6,26]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:sec id=\"j_cclm-2025-0032_abs_001\">\n                    <jats:title>Objectives<\/jats:title>\n                    <jats:p>\n                      The Certified Reference Material (CRM) ERM\n                      <jats:sup>\u00ae<\/jats:sup>\n                      -DA477\/IFCC is a new polyclonal IgG anti-beta2-glycoprotein I (anti-\u03b22GPI) material for the harmonization of the laboratory diagnosis of antiphospholipid syndrome (APS). We evaluated CRM\u2019s ability to represent the heterogeneity of APS patient anti-\u03b22GPI antibodies and to calibrate IgG anti-\u03b22GPI methods.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec id=\"j_cclm-2025-0032_abs_002\">\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>\n                      We characterized CRM for its reactivity against domain-1, using the QUANTA Flash\n                      <jats:sup>\u00ae<\/jats:sup>\n                      \u03b22GPI-domain-1 assay, and against domains-4-5 of \u03b22GPI, and single-domain-deleted \u03b22GPI molecules using in-house ELISAs. We used QUANTA Lite\n                      <jats:sup>\u00ae<\/jats:sup>\n                      ELISA, QUANTA Flash\n                      <jats:sup>\u00ae<\/jats:sup>\n                      CLIA, and EliA\u2122 FEIA methods to evaluate the CRM\u2019s anti-Cardiolipin (anti-CL) activity. Four anti-\u03b22GPI IgG methods (in-house and QUANTA Lite\n                      <jats:sup>\u00ae<\/jats:sup>\n                      ELISA, QUANTA Flash\n                      <jats:sup>\u00ae<\/jats:sup>\n                      CLIA, and EliA\u2122 FEIA) were also used to evaluate the CRM\u2019s calibration efficacy, alongside 133 clinical samples (CSs) and 99 controls.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec id=\"j_cclm-2025-0032_abs_003\">\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>\n                      The CRM showed high anti-domain-1 activity and no anti-domain-4-5 activity at the recommended assay dilution. The domain-dependent-\u03b22GPI reactivity profiles were comparable with full-blown APS. There was acceptable dilution linearity for anti-CL assays with R\n                      <jats:sup>2<\/jats:sup>\n                      ranging from 0.957 to 0.997. For the four anti-\u03b22GPI IgG assays, calibration with the CRM led to a good comparability of the average result of CSs for two of the assays. New cut-offs calculated from this work improved comparability in quantitative results between three of the assays: 85\u202f% concordance with CRM compared to 66\u202f% concordance with assay-specific-calibration.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec id=\"j_cclm-2025-0032_abs_004\">\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>The CRM is representative of patient anti-\u03b22GPI\/CL heterogeneity and should improve anti-\u03b22GPI IgG method harmonization. However, the level of achievable method harmonization is affected by differences in the selectivity among the assays.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1515\/cclm-2025-0032","type":"journal-article","created":{"date-parts":[[2025,3,20]],"date-time":"2025-03-20T05:57:27Z","timestamp":1742450247000},"page":"1315-1326","source":"Crossref","is-referenced-by-count":4,"title":["Antiphospholipid IgG Certified Reference Material ERM\n                    <sup>\u00ae<\/sup>\n                    -DA477\/IFCC: a tool for aPL harmonization?"],"prefix":"10.1515","volume":"63","author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-0811-2472","authenticated-orcid":false,"given":"Claudia","family":"Grossi","sequence":"first","affiliation":[{"name":"Immunorheumatology Research Laboratory , 9354 IRCCS Istituto Auxologico Italiano , Cusano Milanino , Italy"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-6895-0382","authenticated-orcid":false,"given":"Liesbet","family":"Deprez","sequence":"additional","affiliation":[{"name":"European Commission, Joint Research Centre , Geel , Belgium"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-6418-2718","authenticated-orcid":false,"given":"Caterina","family":"Bodio","sequence":"additional","affiliation":[{"name":"Immunorheumatology Research Laboratory , 9354 IRCCS Istituto Auxologico Italiano , Cusano Milanino , Italy"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-8967-9678","authenticated-orcid":false,"given":"Maria Orietta","family":"Borghi","sequence":"additional","affiliation":[{"name":"Immunorheumatology Research Laboratory , 9354 IRCCS Istituto Auxologico Italiano , Cusano Milanino , Italy"},{"name":"Dipartimento di Scienze Cliniche e di Comunit\u00e0, Dipartimento di Eccellenza 2023-2027 , University of Milan , Milan , Italy"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-0710-2520","authenticated-orcid":false,"given":"Suresh","family":"Kumar","sequence":"additional","affiliation":[{"name":"Edward A. Doisy Department of Biochemistry and Molecular Biology , Saint Louis University School of Medicine , St. Louis , MO , USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-2309-7100","authenticated-orcid":false,"given":"Nicola","family":"Pozzi","sequence":"additional","affiliation":[{"name":"Edward A. Doisy Department of Biochemistry and Molecular Biology , Saint Louis University School of Medicine , St. Louis , MO , USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-3079-4019","authenticated-orcid":false,"given":"Paolo","family":"Macor","sequence":"additional","affiliation":[{"name":"Department of Life Sciences , University of Trieste , Trieste , Italy"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-0913-0197","authenticated-orcid":false,"given":"Silvia","family":"Piantoni","sequence":"additional","affiliation":[{"name":"Rheumatology and Clinical Immunology Unit, ASST Spedali Civili, Department of Clinical and Experimental Sciences , University of Brescia, ERN-Reconnect Member , Brescia , Italy"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-4355-9333","authenticated-orcid":false,"given":"Angela","family":"Tincani","sequence":"additional","affiliation":[{"name":"Rheumatology and Clinical Immunology Unit, ASST Spedali Civili, Department of Clinical and Experimental Sciences , University of Brescia, ERN-Reconnect Member , Brescia , Italy"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-1941-2606","authenticated-orcid":false,"given":"Massimo","family":"Radin","sequence":"additional","affiliation":[{"name":"Department of Clinical and Biological Sciences , University Center of Excellence on Nephrologic, Rheumatologic and Rare Diseases (ERK-Net, ERN-Reconnect and RITA-ERN Member) with Nephrology and Dialysis Unit and Center of Immuno-Rheumatology and Rare Diseases (CMID), Coordinating Center of the Interregional Network for Rare Diseases of Piedmont and Aosta Valley, San Giovanni Bosco Hub Hospital, University of Turin , Turin , Italy"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-1266-9441","authenticated-orcid":false,"given":"Savino","family":"Sciascia","sequence":"additional","affiliation":[{"name":"Department of Clinical and Biological Sciences , University Center of Excellence on Nephrologic, Rheumatologic and Rare Diseases (ERK-Net, ERN-Reconnect and RITA-ERN Member) with Nephrology and Dialysis Unit and Center of Immuno-Rheumatology and Rare Diseases (CMID), Coordinating Center of the Interregional Network for Rare Diseases of Piedmont and Aosta Valley, San Giovanni Bosco Hub Hospital, University of Turin , Turin , Italy"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-6434-1769","authenticated-orcid":false,"given":"Gustavo","family":"Martos","sequence":"additional","affiliation":[{"name":"International Bureau of Weights and Measures , S\u00e8vers , France"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-8525-8921","authenticated-orcid":false,"given":"Evanthia","family":"Monogioudi","sequence":"additional","affiliation":[{"name":"Health and Digital Executive Agency of the European Commission , Brussels , Belgium"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Ingrid","family":"Zegers","sequence":"additional","affiliation":[{"name":"European Commission, Scientific Advice Mechanism , Brussels , Belgium"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-6181-4479","authenticated-orcid":false,"given":"Joanna","family":"Sheldon","sequence":"additional","affiliation":[{"name":"Protein Reference Unit , St. George\u2019s Hospital , London , UK"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-1374-7678","authenticated-orcid":false,"given":"Rohan","family":"Willis","sequence":"additional","affiliation":[{"name":"Antiphospholipid Standardization Laboratory , University of Texas Medical Branch , Galveston , TX , USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-3394-1451","authenticated-orcid":false,"given":"Pier Luigi","family":"Meroni","sequence":"additional","affiliation":[{"name":"Immunorheumatology Research Laboratory , 9354 IRCCS Istituto Auxologico Italiano , Cusano Milanino , Italy"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"374","published-online":{"date-parts":[[2025,3,21]]},"reference":[{"key":"2026051214225320619_j_cclm-2025-0032_ref_001","doi-asserted-by":"crossref","unstructured":"Harris, EN, Willis, R. 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