CAJ | 학술논문

制备供免疫分析用的癌胚抗原工作标准品并标定其免疫效价。用4.6mg/L CEA纯品溶液和pH7.4的1%人白蛋白-50mmol Na2HPO4-NaH2PO4溶液配制浓度为320μg/L的工作标准品溶液。将该溶液按每安瓿(amp.)0.5mL(160ng/amp.)分装、冻干。以国产CEA RIA和CEA IRMA药盒现行标准品为对照品，标定工作标准品效价，并与国际参考制剂1st IRP CEA HUMAN 73/601进行对照实验。以药盒标准品为对照品，工作标准品平均免疫效价为163ng/amp.,95%可信限为159-168ng/amp.,工作标准品与国际参考制剂的剂量-反应曲线不显著偏离平行。CEA工作标准品与国际参考制剂1st IRP CEA 73/601在免疫学反应中是同质的，可以作为实验室间对照品使用。
제비공면역분석용적암배항원공작표준품병표정기면역효개。용4.6mg/L CEA순품용액화pH7.4적1%인백단백-50mmol Na2HPO4-NaH2PO4용액배제농도위320μg/L적공작표준품용액。장해용액안매안부(amp.)0.5mL(160ng/amp.)분장、동간。이국산CEA RIA화CEA IRMA약합현행표준품위대조품，표정공작표준품효개，병여국제삼고제제1st IRP CEA HUMAN 73/601진행대조실험。이약합표준품위대조품，공작표준품평균면역효개위163ng/amp.,95%가신한위159-168ng/amp.,공작표준품여국제삼고제제적제량-반응곡선불현저편리평행。CEA공작표준품여국제삼고제제1st IRP CEA 73/601재면역학반응중시동질적，가이작위실험실간대조품사용。
The article is to prepare the working standard of carcinoembryonic antigen (CEA) for immunoassay and determine its potency.CEA solution of 320 μg/L was prepared from purified CEA solution of 4.6mg/L and 1% human albumin solution buffered with 50mmol/L sodium phosphate,pH7.4.This solution was distributed in an aliquot of0.5mL(160 ng per ampoule) and lyophilized.The potency of CEA working standard,in terms of present standard of CEA RIA and IRMA kits made by Chinese manufacturers and in terms of 1st IRP CEA HUMAN 73/601 supplied by WHO,has been determined.Mean immunological potency of the working standard is 163 ng per ampoule with confident limit of 159-168 ng per ampoule at 95% probability level.Test of parallelism of dose-response curve for the working standard to that for 1st IRP CEA HUMAN 73/601 has been passed.CEA working standard is suitable to the kits standard for CEA radioimmunoassay and immunoradiometric assay.