{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,27]],"date-time":"2026-09-27T06:01:03Z","timestamp":1790488863531,"version":"4.1.0"},"reference-count":31,"publisher":"Wiley","issue":"3","license":[{"start":{"date-parts":[[2010,8,24]],"date-time":"2010-08-24T00:00:00Z","timestamp":1282608000000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Annals of Neurology"],"published-print":{"date-parts":[[2010,9]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Objective<\/jats:title>\n                    <jats:p>A study was undertaken to establish an enzyme\u2010linked immunosorbent assay (ELISA) to detect JC virus (JCV)\u2010specific antibodies in multiple sclerosis (MS) patients, and to evaluate its potential utility for identifying patients at higher or lower risk (ie, risk stratification) of developing progressive multifocal leukoencephalopathy (PML).<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>A 2\u2010step assay for detecting and confirming the presence of anti\u2010JCV antibodies in human serum and plasma was developed and demonstrated to be both sensitive and specific. ELISA cutpoints were statistically established using sera from &gt;800 MS patients from natalizumab clinical studies. Subsequently, this assay was used to determine the presence of anti\u2010JCV antibodies in natalizumab\u2010treated PML patients where serum samples were collected 16\u2010180 months prior to the diagnosis of PML.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>\n                      In our evaluation of natalizumab\u2010treated MS patients, 53.6% tested positive for anti\u2010JCV antibodies, with a 95% confidence interval of 49.9 to 57.3%. The false\u2010negative rate of the ELISA was calculated to be approximately 2.5%, with an upper 1\u2010sided confidence limit of 4.4%. Notably, we observed anti\u2010JCV antibodies in all 17 available pre\u2010PML sera samples, which was significantly different from the 53.6% seropositivity observed in the overall MS study population (\n                      <jats:italic>p<\/jats:italic>\n                      &lt; 0.0001).\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Interpretation<\/jats:title>\n                    <jats:p>This 2\u2010step assay provides a means to classify MS patients as having detectable or not detectable levels of anti\u2010JCV antibodies. The finding that all 17 of the pre\u2010PML samples that were available tested seropositive, and none tested seronegative, warrants further research on the clinical utility of the anti\u2010JCV antibody assay as a potential tool for stratifying MS patients for higher or lower risk of developing PML. Ann Neurol 2010<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1002\/ana.22128","type":"journal-article","created":{"date-parts":[[2010,8,29]],"date-time":"2010-08-29T14:00:39Z","timestamp":1283090439000},"page":"295-303","source":"Crossref","is-referenced-by-count":383,"title":["Anti\u2010JC virus antibodies: Implications for PML Risk 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