癌胚抗原工作标准品的制备

Establishment of Carcinoembryonic Antigen Working Standard for Immunoassay

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/LCEA纯品溶液和 pH7.4的1%人白蛋白 - 5 0mmolNa2 HPO4 -NaH2 PO4 溶液配制浓度为 32 0 μg/L的工作标准品溶液。将该溶液按每安瓿(amp .) 0 .5mL(16 0ng/amp .)分装、冻干。以国产CEARIA和CEAIRMA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 1stIRPCEAHUMAN 73/ 6 0 1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 16 3ng/amp .,95 %可信限为 15 9- 16 8ng/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 1stIRPCEA 73/ 6 0 1在免疫学反应中是同质的 。

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.