{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,3,10]],"date-time":"2026-03-10T14:05:16Z","timestamp":1773151516669,"version":"3.50.1"},"reference-count":15,"publisher":"Oxford University Press (OUP)","issue":"2","license":[{"start":{"date-parts":[[2004,2,1]],"date-time":"2004-02-01T00:00:00Z","timestamp":1075593600000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/academic.oup.com\/journals\/pages\/open_access\/funder_policies\/chorus\/standard_publication_model"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[2004,2,1]]},"abstract":"<jats:title>Abstract<\/jats:title>\n               <jats:p>Background: The Bio-Intact parathyroid hormone (1\u201384) assay (Bio-PTH), a newly developed two-site immunochemiluminometric assay, measures exclusively PTH (1\u201384) in contrast to second-generation \u201cintact PTH\u201d (I-PTH) assays. We investigated the technical performance and clinical significance of this new assay.<\/jats:p>\n               <jats:p>Methods: PTH was measured simultaneously by the Bio-PTH assay and Allegro intact PTH IRMA in sera from Japanese patients with calcium disorders.<\/jats:p>\n               <jats:p>Results: Measured Bio-PTH in serum was unaffected by six freeze-thaw cycles and was stable at 4 \u00b0C for 7 days and during storage at \u221220 or \u221280 \u00b0C over 28 days. The calibration curve was linear to 1800 ng\/L. The detection limit was 3.9 ng\/L. The intra- and interassay imprecision was &amp;lt;2.8% and 3.5%, respectively, for analyte concentrations spanning the range of the calibration curve. Bio-PTH was unaffected by a 1000-fold excess of PTH (7\u201384), although I-PTH reacted equally with PTH (7\u201384) and PTH (1\u201384). Bio-PTH was correlated with I-PTH in healthy individuals (r = 0.953; P &amp;lt;0.0001; n = 26) and in the full population without renal dysfunction (r = 0.994; P &amp;lt;0.0001; n = 62). In 72 volunteers, mean (SD) Bio-PTH was 22.2 (7.1) ng\/L, or 62% of the mean I-PTH [36.1 (22.3) ng\/L]. This ratio was 51% in hemodialysis patients (n = 177). Mean Bio-PTH was high in patients with primary hyperparathyroidism [121 (85) ng\/L; n = 18] and hemodialysis patients [102 (104) ng\/L; n = 177], low in idiopathic hypoparathyroidism [5.5 (2.8) ng\/L; n = 4], and within 2 SD of the mean for healthy controls in Paget disease of the bone [34 (15) ng\/L; n = 9] and bone metastasis [24 (12) ng\/L; n = 8].<\/jats:p>\n               <jats:p>Conclusion: The Bio-PTH assay is sensitive and precise and produces expected results for patients with the studied disorders of calcium metabolism.<\/jats:p>","DOI":"10.1373\/clinchem.2003.026831","type":"journal-article","created":{"date-parts":[[2004,2,3]],"date-time":"2004-02-03T19:51:24Z","timestamp":1075837884000},"page":"385-390","source":"Crossref","is-referenced-by-count":61,"title":["Technical and Clinical Characterization of the Bio-PTH (1\u201384) Immunochemiluminometric Assay and Comparison with a Second-Generation Assay for Parathyroid Hormone"],"prefix":"10.1093","volume":"50","author":[{"given":"Masaaki","family":"Inaba","sequence":"first","affiliation":[{"name":"Department of Metabolism, Endocrinology and Molecular Medicine, Osaka City University Graduate School of Medicine, Osaka, Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Kiyoshi","family":"Nakatsuka","sequence":"first","affiliation":[{"name":"Department of Metabolism, Endocrinology and Molecular Medicine, Osaka City University Graduate School of Medicine, Osaka, Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Yasuo","family":"Imanishi","sequence":"first","affiliation":[{"name":"Department of Metabolism, Endocrinology and Molecular Medicine, Osaka City University Graduate School of Medicine, Osaka, Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Masakazu","family":"Watanabe","sequence":"first","affiliation":[{"name":"SRL Inc., Tokyo, Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Yuji","family":"Mamiya","sequence":"first","affiliation":[{"name":"SRL Inc., Tokyo, Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Eiji","family":"Ishimura","sequence":"first","affiliation":[{"name":"Department of Metabolism, Endocrinology and Molecular Medicine, Osaka City University Graduate School of Medicine, Osaka, Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Yoshiki","family":"Nishizawa","sequence":"first","affiliation":[{"name":"Department of Metabolism, Endocrinology and Molecular Medicine, Osaka City University Graduate School of Medicine, Osaka, Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"286","published-online":{"date-parts":[[2004,2,1]]},"reference":[{"key":"2020030122554912200_R1","doi-asserted-by":"crossref","first-page":"805","DOI":"10.1093\/clinchem\/44.4.805","volume":"44","year":"1998","journal-title":"Clin 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