Establishment, value assignment, and characterization of new WHO reference reagents for six molecular forms of human chorionic gonadotropin
Establishment, value assignment, and characterization of new WHO reference reagents for six molecular forms of human chorionic gonadotropin
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DOI：
10.1373/clinchem.2004.038679
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发表时间：
2005-01-01
影响因子：
9.3
通讯作者：
Sturgeon, C
中科院分区：
文献类型：
--
作者：
Bristow, A;Berger, P;Sturgeon, C
背景：国际临床化学和检验医学联合会(IFCC)成立了一个工作组，研究如何提高人绒毛膜促性腺激素(HCG)免疫分析方法的可比性，hCG被选为糖蛋白原型分析物。方法：从人绒毛膜促性腺激素粗品中提纯完整的人绒毛膜促性腺激素、人绒毛膜促性腺激素、人绒毛膜促性腺激素β亚基、人绒毛膜促性腺激素α亚单位、人绒毛膜促性腺激素α亚基和人绒毛膜促性腺激素β核心片段，安瓶，冻干，并指定物质浓度(摩尔/L)。结果：根据重建后免疫活性物质的回收情况，对安瓶标准进行了定值和加速降解研究。降解性研究表明，该标准具有较高的稳定性。结论：IFCC已通过了hCG相关分子的命名和免疫分析方法，工作组编制和表征的标准已被WHO正式采纳为首批6种hCG相关分子的国际参考试剂。这些进展将使人们能够更好地了解hCG的检测方法，并最终有助于提高这些检测方法的临床应用。(C)2005年美国临床化学协会。
Background: The International Federation of Clinical Chemistry and Laboratory Medicine (IFCC) established a Working Group to investigate means of improving the comparability of immunoassays for human chorionic gonadotropin (hCG), which was selected as a prototype glycoprotein analyte. The Working Group identified development of unambiguous nomenclature and production of new highly purified International Reference Reagents calibrated in substance concentrations as its primary objectives.Methods: Preparations of intact hCG, nicked hCG, hCG beta-subunit, nicked hCG beta-subunit, hCG a-subunit, and hCG beta-core fragment were purified from a crude urinary hCG preparation, ampouled, lyophilized, and assigned values in substance concentrations (mol/L). Value assignment and accelerated degradation studies were carried out in accordance with WHO protocols for International Reference Reagents.Results: The ampouled standards were assigned final values based on the recovery of immunoreactive material after reconstitution. The degradation studies showed that the standards were highly stable.Conclusions: The nomenclature of hCG-related molecules and immunoassays has been adopted by the IFCC, and the standards prepared and characterized by the Working Group have been formally adopted by the WHO as the First International Reference Reagents for six hCG-related molecules. These developments will enable better understanding of what assays for hCG measure and should ultimately help to improve the clinical application of these assays. (C) 2005 American Association for Clinical Chemistry.