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Endocrinology and Metabolism |
1 Department of Metabolism, Endocrinology and Molecular Medicine, Osaka City University Graduate School of Medicine, Osaka, Japan.
2 SRL Inc., Tokyo, Japan.
aAddress correspondence to this author at: Department of Metabolism, Endocrinology and Molecular Medicine, Osaka City University Graduate School of Medicine, 1-4-3, Asahi-machi, Abeno-ku, Osaka 545-8585, Japan. Fax 81-6-6645-3808; e-mail inaba-m{at}med.osaka-cu.ac.jp.
Background: The Bio-Intact parathyroid hormone (1–84) 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 °C 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 <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 (7–84), although I-PTH reacted equally with PTH (7–84) and PTH (1–84). Bio-PTH was correlated with I-PTH in healthy individuals (r = 0.953; P <0.0001; n = 26) and in the full population without renal dysfunction (r = 0.994; P <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].
Conclusion: The Bio-PTH assay is sensitive and precise and produces expected results for patients with the studied disorders of calcium metabolism.
The following articles in journals at HighWire Press have cited this article:
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  M. Haarhaus, A. Fernstrom, M. Magnusson, and P. Magnusson Clinical significance of bone alkaline phosphatase isoforms, including the novel B1x isoform, in mild to moderate chronic kidney disease Nephrol. Dial. Transplant., November 1, 2009; 24(11): 3382 - 3389. [Abstract] [Full Text] [PDF]
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P. Boudou, F. Ibrahim, C. Cormier, E. Sarfati, and J.-C. Souberbielle Unexpected Serum Parathyroid Hormone Profiles in Some Patients with Primary Hyperparathyroidism Clin. Chem., April 1, 2006; 52(4): 757 - 760. [Abstract] [Full Text] [PDF]
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T. Kawata, Y. Imanishi, K. Kobayashi, N. Onoda, Y. Takemoto, H. Tahara, S. Okuno, E. Ishimura, T. Miki, T. Ishikawa, et al. Direct in Vitro Evidence of Extracellular Ca2+-Induced Amino-Terminal Truncation of Human Parathyroid Hormone (1-84) by Human Parathyroid Cells J. Clin. Endocrinol. Metab., October 1, 2005; 90(10): 5774 - 5778. [Abstract] [Full Text] [PDF]
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T. K. Teal, J. L. Wood, P. E. Stevens, and E. J. Lamb Stability of Bio-Intact (1-84) Parathyroid Hormone ex Vivo in Serum and EDTA Plasma from Hemodialysis Patients Clin. Chem., September 1, 2004; 50(9): 1713 - 1714. [Full Text] [PDF]
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