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日本甲状旁腺激素控制调查以确定方法间和实验室间的差异。

Parathyroid hormone control survey to determine inter-method and inter-lab variations in Japan.

作者信息

Kakuta Takatoshi, Kato Hitoshi, Komaba Hirotaka, Akizawa Tadao

机构信息

Division of Nephrology, Endocrinology and Metabolism, Tokai University School of Medicine, Isehara, Kanagawa, Japan.

出版信息

Ther Apher Dial. 2011 Jun;15 Suppl 1:50-5. doi: 10.1111/j.1744-9987.2011.00927.x.

DOI:10.1111/j.1744-9987.2011.00927.x
PMID:21595853
Abstract

For uremic patients, Kidney Disease: Improving Global Outcomes suggest that parathyroid hormone (PTH) levels should be maintained within approximately 2-9 times the upper normal limit for the assay. One of reasons for the lack of definite approximate PTH values is the inability to use the Allegro Intact PTH assay from Nicols. We aimed to evaluate whether other parathyroid hormone assays were suitable for these assessments. We compared the parathyroid hormone concentrations measured with five commercial immunoassays by using three serum pools and seven artificially spiked samples of parathyroid hormone; the Total Intact parathyroid hormone assay was used as the reference assay. Although the results of parathyroid hormone assays showed high correlation, the concentrations differed from Yamasa's assay to another. And the third/second-generation assay ratio was approximately 60%. Further, the Immulite assay overestimated the levels of 1-84 PTH. We showed important inter-method variations in the parathyroid hormone assays used in Japan.

摘要

对于尿毒症患者,改善全球肾脏病预后组织建议甲状旁腺激素(PTH)水平应维持在检测正常上限的约2至9倍范围内。缺乏明确的近似PTH值的原因之一是无法使用尼科尔斯公司的Allegro全段甲状旁腺激素检测方法。我们旨在评估其他甲状旁腺激素检测方法是否适用于这些评估。我们使用三个血清池和七个甲状旁腺激素人工加标样本,比较了五种商业免疫分析方法所测得的甲状旁腺激素浓度;以总全段甲状旁腺激素检测方法作为参考检测方法。尽管甲状旁腺激素检测结果显示出高度相关性,但不同检测方法测得的浓度有所差异,从山之内公司的检测方法到其他检测方法均是如此。并且第三代/第二代检测方法的比例约为60%。此外,免疫发光检测方法高估了1-84 PTH的水平。我们发现日本所使用的甲状旁腺激素检测方法存在重要的方法间差异。

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Ther Apher Dial. 2011 Jun;15 Suppl 1:50-5. doi: 10.1111/j.1744-9987.2011.00927.x.
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Full-length versus intact PTH concentrations in pseudohypoparathyroidism type 1 and primary hyperparathyroidism: clinical evaluation of immunoassays in individuals from China.假性甲状旁腺功能减退症 1 型和原发性甲状旁腺功能亢进症中全长和完整 PTH 浓度:来自中国个体的免疫分析临床评估。
Endocrine. 2022 Dec;78(3):605-614. doi: 10.1007/s12020-022-03204-7. Epub 2022 Oct 11.
2
Variation in parathyroid hormone immunoassay results--a critical governance issue in the management of chronic kidney disease.甲状旁腺激素免疫测定结果的变化--慢性肾脏病管理中的一个关键治理问题。
Nephrol Dial Transplant. 2011 Nov;26(11):3440-5. doi: 10.1093/ndt/gfr614.