{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,5,16]],"date-time":"2026-05-16T03:46:32Z","timestamp":1778903192613,"version":"3.51.4"},"reference-count":26,"publisher":"Walter de Gruyter GmbH","issue":"2","content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Clinical Chemistry and Laboratory Medicine"],"published-print":{"date-parts":[[2010,2,1]]},"abstract":"<jats:title>Abstract<\/jats:title>\n               <jats:p>\n                  <jats:bold>Background:<\/jats:bold> A reliable early marker is required for diagnosis of cobalamin deficiency. We calculated an appropriate holotranscobalamin (HoloTC) cut-off point for identifying cobalamin deficiency using an immunoenzymatic assay.<\/jats:p>\n               <jats:p>\n                  <jats:bold>Methods:<\/jats:bold> Determination of the cut-off threshold and correlation between HoloTC and the other diagnostic parameters routinely used for vitamin B<jats:sub>12<\/jats:sub> deficiency [total vitamin B<jats:sub>12<\/jats:sub> (tB<jats:sub>12<\/jats:sub>), folate, homocysteine] were measured in 250 routine blood specimens from 107 men (mean age 59.0\u00b118.8\u00a0years) and 143 women (mean age 54.2\u00b123.1\u00a0years). The inclusion criterion was serum tB<jats:sub>12<\/jats:sub> concentration \u2264221\u00a0pmol\/L.<\/jats:p>\n               <jats:p>\n                  <jats:bold>Results:<\/jats:bold> Analytical performance results agreed with those reported by others. A weak correlation (R=0.42) was found between HoloTC and tB<jats:sub>12<\/jats:sub>. A 40 pmol\/L cut-off threshold was chosen for HoloTC and the associated sensitivity and specificity was 0.86 and 0.66, respectively. Out of 250 tested samples, 126 showed tB<jats:sub>12<\/jats:sub> concentrations 139\u2013221\u00a0pmol\/L (gray zone, GZ) and 124 had tB<jats:sub>12<\/jats:sub> concentrations &lt;139\u00a0pmol\/L (low, L). Values less than the cut-off for HoloTC were present in 68.2% and 37.9% of cases in the GZ and L group, respectively (p&lt;0.01), and in 53.2% of subjects.<\/jats:p>\n               <jats:p>\n                  <jats:bold>Conclusions:<\/jats:bold> Our results confirmed the analytical reliability of the AxSYM HoloTC assay. The method is adequate for routine use and a cut-off threshold of 40\u00a0pmol\/L is appropriate for assessing cobalamin deficiency in populations with reduced tB<jats:sub>12<\/jats:sub> values.<\/jats:p>\n               <jats:p>Clin Chem Lab Med 2010;48:249\u201353.<\/jats:p>","DOI":"10.1515\/cclm.2010.032","type":"journal-article","created":{"date-parts":[[2009,12,7]],"date-time":"2009-12-07T14:33:03Z","timestamp":1260196383000},"page":"249-253","source":"Crossref","is-referenced-by-count":31,"title":["Determination of serum holotranscobalamin concentrations with the AxSYM active B<sub>12<\/sub> assay: cut-off point evaluation in the clinical laboratory"],"prefix":"10.1515","volume":"48","author":[{"given":"Fabrizia","family":"Bamonti","sequence":"first","affiliation":[{"name":"Dipartimento Scienze Mediche, Universit\u00e0 degli Studi di Milano, Ospedale Maggiore Policlinico, Mangiagalli e Regina Elena, Fondazione IRCCS, Milan, Italy"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Giovanna Antonella","family":"Moscato","sequence":"additional","affiliation":[{"name":"U.O. Laboratorio di Analisi Chimico-Cliniche Ospedale di Cisanello, Azienda Ospedaliero-Universitaria Pisana, Pisa, Italy"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Cristina","family":"Novembrino","sequence":"additional","affiliation":[{"name":"Dipartimento Scienze Neurologiche, Centro \u201cDino Ferrari\u201d, Universit\u00e0 degli Studi di Milano, Ospedale Maggiore Policlinico, Mangiagalli e Regina Elena, Fondazione IRCCS, Milan, Italy"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Dario","family":"Gregori","sequence":"additional","affiliation":[{"name":"Department of Environmental Medicine and Public Health, Labs of Biostatistics and Epidemiological Methods, University of Padova, Padua, Italy"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Claudia","family":"Novi","sequence":"additional","affiliation":[{"name":"U.O. 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