Clinical Evaluation of the Elecsys β-CrossLaps Serum Assay, a New Assay for Degradation Products of Type I Collagen C-Telopeptides

内科学 内分泌学 脱氧吡啶啉 假性甲状旁腺机能减退 化学 甲状旁腺功能亢进 免疫分析 甲状旁腺激素 浊度法 Ⅰ型胶原 维生素D与神经学 骨钙素 医学 抗体 碱性磷酸酶 免疫学 生物化学
作者
Reiko Okabe,Kiyoshi Nakatsuka,Masaaki Inaba,Masamichi Takami,Hiroshi Naka,Hideki Masaki,Atushi Moriguchi,Yoshiki Nishizawà
出处
期刊:Clinical Chemistry [Oxford University Press]
卷期号:47 (8): 1410-1414 被引量:101
标识
DOI:10.1093/clinchem/47.8.1410
摘要

The Elecsys beta-CrossLaps serum assay measures type I collagen degradation fragments (beta-CTx) that contain the beta-isomerized octapeptide EKAHD-beta-GGR. We investigated the analytical performance of the assay and changes in beta-CrossLaps in patients with metabolic bone diseases.The electrochemiluminescent sandwich immunoassay uses two monoclonal antibodies directed against different regions of the linear EKAHD-beta-GGR.beta-CrossLaps (beta-CTx) immunoreactivity was stable in serum and plasma stored at 4 degrees C for 24 h or at room temperature for 4 h, and it did not decrease appreciably in samples stored at -30 degrees C for 12 weeks. Nine cycles of repeated freezing-thawing did not affect serum beta-CTx. The intra- and interassay imprecision (CVs) for four samples was < or = 2.6% (n = 10) and < or = 4.1% (n = 10), respectively. The mean day-to-day biological variation (CV) was 20% in 10 postmenopausal women (n = 10 days). Serum beta-CTx and osteocalcin were correlated in patients with hyperparathyroidism (r = 0.796; P <0.0001; n = 28), chronic renal failure on hemodialysis (r = 0.784; P = 0.0003; n = 16), hypoparathyroidism (r = 0.950; P = 0.0001; n = 11), and pseudohypoparathyroidism (r = 0.987; P = 0.130; n = 4). Serum beta-CTx decreased by 47.4% +/- 8.8% (mean +/- SD) and 60.7% +/- 6.5% at 3 and 6 months, respectively, after initiation of estrogen replacement therapy in 34 women. These decreases were greater than the decreases in urinary excretion of deoxypyridinoline (31.8% +/- 3.9% and 38.1% +/- 4.4%, respectively) or pyridinoline cross-linked C-terminal telopeptide of type I collagen (15.9% +/- 3.9% and 16.9% +/- 4.6%, respectively).The Elecsys beta-CrossLaps serum assay provides a potentially useful tool for assessing bone resorption state, including its response to estrogen replacement therapy.
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