Bristow Adrian, Berger Peter, Bidart Jean-Michel, Birken Steven, Norman Robert, Stenman Ulf-Håkan, Sturgeon Catharine
National Institute for Biological Standards and Control, Potters Bar, Herts, UK.
Clin Chem. 2005 Jan;51(1):177-82. doi: 10.1373/clinchem.2004.038679. Epub 2004 Oct 28.
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.
Preparations of intact hCG, nicked hCG, hCG beta-subunit, nicked hCG beta-subunit, hCG alpha-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.
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.
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.
国际临床化学与检验医学联合会（IFCC）成立了一个工作组，以研究提高人绒毛膜促性腺激素（hCG）免疫测定可比性的方法，hCG被选为原型糖蛋白分析物。该工作组确定了制定明确的命名法以及生产以物质浓度校准的新型高纯度国际参考试剂为其主要目标。
从粗制尿hCG制剂中纯化完整hCG、缺口hCG、hCGβ亚基、缺口hCGβ亚基、hCGα亚基和hCGβ核心片段的制剂，装入安瓿，冻干，并赋予物质浓度（mol/L）值。根据世界卫生组织国际参考试剂方案进行赋值和加速降解研究。
根据复溶后免疫反应性物质的回收率，为安瓿标准品赋予最终值。降解研究表明这些标准品非常稳定。
IFCC已采用hCG相关分子和免疫测定的命名法，工作组制备并表征的标准品已被世界卫生组织正式采纳为六种hCG相关分子的首批国际参考试剂。这些进展将有助于更好地理解hCG测定所检测的内容，并最终应有助于改善这些测定的临床应用。
