{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,7,29]],"date-time":"2026-07-29T23:23:17Z","timestamp":1785367397656,"version":"3.55.0"},"reference-count":25,"publisher":"SAGE Publications","license":[{"start":{"date-parts":[[2025,1,1]],"date-time":"2025-01-01T00:00:00Z","timestamp":1735689600000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"},{"start":{"date-parts":[[2025,1,1]],"date-time":"2025-01-01T00:00:00Z","timestamp":1735689600000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/journals.sagepub.com\/page\/policies\/text-and-data-mining-license"}],"content-domain":{"domain":["journals.sagepub.com"],"crossmark-restriction":true},"short-container-title":["Ther Adv Neurol Disord"],"published-print":{"date-parts":[[2025,1]]},"abstract":"<jats:sec>\n                    <jats:title>Background:<\/jats:title>\n                    <jats:p>Two principal methods for detecting anti-John Cunningham virus (JCV) antibodies are currently utilized in clinical practice: STRATIFY JCV\u2122, an ELISA developed by Biogen, and IMMUNOWELL\u2122, a solid-phase ELISA assay by Polpharma Biologics\/GenBio.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Objective:<\/jats:title>\n                    <jats:p>We aimed to evaluate the concordance between STRATIFY and IMMUNOWELL in detecting anti-JCV antibodies in a real-world population of patients with relapsing-remitting multiple sclerosis (RRMS) undergoing natalizumab therapy.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Design:<\/jats:title>\n                    <jats:p>This monocentric observational study screened all patients treated with natalizumab for at least 6\u2009months, referring to the MS Center of the University Hospital of Catania.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods:<\/jats:title>\n                    <jats:p>Each patient\u2019s serum was tested simultaneously using STRATIFY-2 (STRATIFY JCV DxSelect) and IMMUNOWELL assays. The qualitative results (positive\/negative) were compared, and the index values were analyzed using Pearson\u2019s correlation and Bland\u2013Altman plots. Inter-method agreement was calculated using Cohen\u2019s kappa coefficient.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results:<\/jats:title>\n                    <jats:p>\n                      Among the 120 patients tested, 82 were positive and 31 negative with both STRATIFY and IMMUNOWELL. Four cases were STRATIFY-negative but IMMUNOWELL-positive, and three were the opposite. Overall concordance was 94.2%, with a Cohen\u2019s Kappa of 0.86, indicating strong agreement. The index values showed strong correlation (Pearson\n                      <jats:italic toggle=\"yes\">r<\/jats:italic>\n                      \u2009=\u20090.79,\n                      <jats:italic toggle=\"yes\">p<\/jats:italic>\n                      \u2009&lt;\u20090.001) and the coefficient of determination (\n                      <jats:italic toggle=\"yes\">r<\/jats:italic>\n                      <jats:sup>2<\/jats:sup>\n                      ) was 0.62.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusion:<\/jats:title>\n                    <jats:p>STRATIFY and IMMUNOWELL demonstrate a high level of agreement in the detection of anti-JCV antibodies in patients with RRMS receiving natalizumab. IMMUNOWELL may serve as a reliable complementary method, especially in cases where borderline serostatus could influence therapeutic strategy. Regular and accurate monitoring of JCV status remains essential for guiding long-term treatment safety and optimizing individual patient outcomes.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1177\/17562864251374972","type":"journal-article","created":{"date-parts":[[2025,11,12]],"date-time":"2025-11-12T11:10:46Z","timestamp":1762945846000},"update-policy":"https:\/\/doi.org\/10.1177\/sage-journals-update-policy","source":"Crossref","is-referenced-by-count":2,"title":["Comparative evaluation of STRATIFY JCV\u2122 and IMMUNOWELL\u2122 assays for anti-JCV antibody detection in natalizumab-treated RRMS patients"],"prefix":"10.1177","volume":"18","author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-1607-543X","authenticated-orcid":false,"given":"Clara Grazia","family":"Chisari","sequence":"first","affiliation":[{"name":"Section of Neurosciences, Department \u201cGF Ingrassia,\u201d University of Catania, via S. Sofia 78, Catania 95129, Italy"},{"name":"Department of Medical, Surgical Sciences and Advanced Technologies \u201cGF Ingrassia,\u201d University of Catania, Catania, Italy"},{"name":"UOS Multiple Sclerosis, Neurology Clinic, \u201cG. Rodolico\u2014San Marco\u201d University Hospital, Catania, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Giulio","family":"Spampinato","sequence":"additional","affiliation":[{"name":"UOS Multiple Sclerosis, Neurology Clinic, \u201cG. Rodolico\u2014San Marco\u201d University Hospital, Catania, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Pina","family":"Crim\u00ec","sequence":"additional","affiliation":[{"name":"UOS Multiple Sclerosis, Neurology Clinic, \u201cG. Rodolico\u2014San Marco\u201d University Hospital, Catania, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Erika","family":"Ferraro","sequence":"additional","affiliation":[{"name":"UOS Multiple Sclerosis, Neurology Clinic, \u201cG. Rodolico\u2014San Marco\u201d University Hospital, Catania, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Salvatore","family":"Lo Fermo","sequence":"additional","affiliation":[{"name":"UOS Multiple Sclerosis, Neurology Clinic, \u201cG. Rodolico\u2014San Marco\u201d University Hospital, Catania, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Vincenzo","family":"Cimino","sequence":"additional","affiliation":[{"name":"Unit\u00e0 Spinale Unipolare, AOE Cannizzaro, Catania, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mario","family":"Zappia","sequence":"additional","affiliation":[{"name":"Department of Medical, Surgical Sciences and Advanced Technologies \u201cGF Ingrassia,\u201d University of Catania, Catania, Italy"},{"name":"UOS Multiple Sclerosis, Neurology Clinic, \u201cG. Rodolico\u2014San Marco\u201d University Hospital, Catania, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-6923-0846","authenticated-orcid":false,"given":"Francesco","family":"Patti","sequence":"additional","affiliation":[{"name":"Section of Neurosciences, Department \u201cGF Ingrassia,\u201d University of Catania, via S. Sofia 78, Catania 95129, Italy"},{"name":"Department of Medical, Surgical Sciences and Advanced Technologies \u201cGF Ingrassia,\u201d University of Catania, Catania, Italy"},{"name":"UOS Multiple Sclerosis, Neurology Clinic, \u201cG. Rodolico\u2014San Marco\u201d University Hospital, Catania, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"179","published-online":{"date-parts":[[2025,11,12]]},"reference":[{"key":"e_1_3_4_2_2","doi-asserted-by":"publisher","DOI":"10.1002\/ana.24286"},{"key":"e_1_3_4_3_2","doi-asserted-by":"publisher","DOI":"10.1177\/1352458513475489"},{"key":"e_1_3_4_4_2","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa1107829"},{"key":"e_1_3_4_5_2","doi-asserted-by":"publisher","DOI":"10.1177\/1352458517728814"},{"key":"e_1_3_4_6_2","doi-asserted-by":"publisher","DOI":"10.1002\/ana.23893"},{"key":"e_1_3_4_7_2","doi-asserted-by":"publisher","DOI":"10.1002\/ana.22107"},{"key":"e_1_3_4_8_2","doi-asserted-by":"publisher","DOI":"10.1016\/S1474-4422(17)30282-X"},{"key":"e_1_3_4_9_2","doi-asserted-by":"publisher","DOI":"10.1007\/s13311-017-0570-7"},{"key":"e_1_3_4_10_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.jcv.2013.02.002"},{"key":"e_1_3_4_11_2","unstructured":"UNILABS. 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