{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,7,9]],"date-time":"2026-07-09T04:24:00Z","timestamp":1783571040644,"version":"3.55.0"},"reference-count":19,"publisher":"Oxford University Press (OUP)","issue":"9","license":[{"start":{"date-parts":[[2017,9,1]],"date-time":"2017-09-01T00:00:00Z","timestamp":1504224000000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/academic.oup.com\/journals\/pages\/open_access\/funder_policies\/chorus\/standard_publication_model"}],"funder":[{"name":"Study grant to the JGU Medical Center from Roche Diagnostics"},{"DOI":"10.13039\/100006733","name":"Indiana University","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100006733","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/100004337","name":"Roche","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100004337","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[2017,9,1]]},"abstract":"<jats:title>Abstract<\/jats:title>\n               <jats:sec>\n                  <jats:title>BACKGROUND<\/jats:title>\n                  <jats:p>The objective of this study is the validation and proof of clinical relevance of a novel electrochemiluminescence immunoassay (ECLIA) for the determination of serum calcitonin (CT) in patients with medullary thyroid carcinoma (MTC) and in different diseases of the thyroid and of calcium homeostasis.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>METHODS<\/jats:title>\n                  <jats:p>This was a multicenter prospective study on basal serum CT concentrations performed in 9 US and European referral institutions. In addition, stimulated CT concentrations were measured in 50 healthy volunteers after intravenous calcium administration (2.5 mg\/kg bodyweight).<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>RESULTS<\/jats:title>\n                  <jats:p>In total, 1929 patients and healthy controls were included. Limits of blank, detection, and quantification for the ECLIA were 0.3, 0.5, and 1 ng\/L, respectively. Highest intra- and interassay coefficients of variation were 7.4% (CT concentration, 0.8 ng\/L) and 7.0% (1.1 ng\/L), respectively. Medians (interval) of serum CT concentrations in 783 healthy controls were 0.8 ng\/L (&amp;lt;0.5\u201312.7) and 3 ng\/L (&amp;lt;0.5\u201318) for females and males, respectively (97.5th percentile, 6.8 and 11.6 ng\/L, respectively). Diagnostic sensitivity and specificity were 100%\/97.1% and 96.2%\/96.4%, for female\/males, respectively. Patients (male\/female) with primary hyperparathyroidism, renal failure, and neuroendocrine tumors showed CT concentrations &amp;gt;97.5th percentile in 33%\/4.7%, 18.5%\/10%, and 8.3%\/12%, females\/males, respectively. Peak serum CT concentrations were reached 2 min after calcium administration (161.7 and 111.8 ng\/L in males and females, respectively; P &amp;lt; 0.001).<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>CONCLUSIONS<\/jats:title>\n                  <jats:p>Excellent analytical performance, low interindividual variability, and low impact of confounders for increased CT concentrations in non-MTC patients indicate that the investigated assay has appropriate clinical utility. Calcium-stimulated CT results suggest good test applicability owing to low interindividual variability.<\/jats:p>\n               <\/jats:sec>","DOI":"10.1373\/clinchem.2016.270009","type":"journal-article","created":{"date-parts":[[2017,7,7]],"date-time":"2017-07-07T20:55:29Z","timestamp":1499460929000},"page":"1489-1496","source":"Crossref","is-referenced-by-count":41,"title":["United States and European Multicenter Prospective Study for the Analytical Performance and Clinical Validation of a Novel Sensitive Fully Automated Immunoassay for Calcitonin"],"prefix":"10.1093","volume":"63","author":[{"given":"George J","family":"Kahaly","sequence":"first","affiliation":[{"name":"Molecular Thyroid Research Laboratory, Department of Medicine I, Johannes Gutenberg University Medical Center, Mainz, Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Alicia","family":"Algeciras-Schimnich","sequence":"first","affiliation":[{"name":"Mayo Clinic, Rochester, MN"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Thomas E","family":"Davis","sequence":"first","affiliation":[{"name":"Indiana University School of Medicine, Indianapolis, IN"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Tanja","family":"Diana","sequence":"first","affiliation":[{"name":"Molecular Thyroid Research Laboratory, Department of Medicine I, Johannes Gutenberg University Medical Center, Mainz, Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Joachim","family":"Feldkamp","sequence":"first","affiliation":[{"name":"City Hospital, Bielefeld, Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Stefan","family":"Karger","sequence":"first","affiliation":[{"name":"Clinic for Endocrinology and Nephrology, Leipzig University, Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jochem","family":"K\u00f6nig","sequence":"first","affiliation":[{"name":"Institute of Medical Biostatistics, Epidemiology and Informatics, JGU Medical Center, Mainz, Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mark A","family":"Lupo","sequence":"first","affiliation":[{"name":"Thyroid & Endocrine Center of Florida, Sarasota, FL"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Friedhelm","family":"Raue","sequence":"first","affiliation":[{"name":"Endocrine Practice, Heidelberg, Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Matthew D","family":"Ringel","sequence":"first","affiliation":[{"name":"The Ohio State University College of Medicine and Arthur G. 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