Technical and clinical characterization of the Bio-PTH (1-84) immunochemiluminometric assay and comparison with a second-generation assay for parathyroid hormone
Technical and clinical characterization of the Bio-PTH (1-84) immunochemiluminometric assay and comparison with a second-generation assay for parathyroid hormone
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DOI：
10.1373/clinchem.2003.026831
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发表时间：
2004-02-01
影响因子：
9.3
通讯作者：
Nishizawa, Y
中科院分区：
文献类型：
--
作者：
Inaba, M;Nakatsuka, K;Nishizawa, Y
背景：生物完整甲状旁腺激素（184）测定法（Bio-PTH）是一种新开发的双位点免疫化学发光测定法，与第二代“完整甲状旁腺激素”（I-PTH）测定法相比，它只测量PTH（1-84）。我们研究了这种新方法的技术性能和临床意义。方法：采用Bio-PTH法和Allegro完整PTH IRMA法同时测定日本钙血症患者血清中PTH的含量。结果：血清中测得的生物甲状旁腺激素（Bio-PTH）在6次冻融循环中不受影响，在4℃下稳定保存7天，在-20或-80℃下保存28天。校准曲线在1800 ng/L范围内呈线性。检出限为3.9 ng/L。测定内、间不精密度为
Background: The Bio-Intact parathyroid hormone (184) assay (Bio-PTH), a newly developed two-site immunochemiluminometric assay, measures exclusively PTH (1-84) in contrast to second-generation "intact PTH" (I-PTH) assays. We investigated the technical performance and clinical significance of this new assay.Methods: PTH was measured simultaneously by the Bio-PTH assay and Allegro intact PTH IRMA in sera from Japanese patients with calcium disorders.Results: Measured Bio-PTH in serum was unaffected by six freeze-thaw cycles and was stable at 4 degreesC for 7 days and during storage at -20 or -80 C 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