肿瘤标志物质控血清的研制及其初步应用

Study of the home-made quality control serum for tumor markers and its application

目的研制一种可用于临床肿瘤标志物检测的液性质控血清。方法利用冷冻血清在溶解过程中自然分层的原理,用日常检测血清为原料,30%乙烯乙二醇(EG)作稳定剂,制备肿瘤标志物[甲胎蛋白(AFP)、癌胚抗原(CEA)、糖类蛋白125(CA125)、CA153、CA199]高、低二水平,以及前列腺特异性抗原(PSA)、神经元特异性烯醇化酶(NSE)、β-绒毛膜促性腺激素(β-HCG)、CA-724、CY2-11高、中、低三水平的液性质控物,以美国BIO-RAD公司的定值冻干质控物为对照,对不同水平液性质控物血清的稳定性进行评价。结果自制质控血清和BIO-RAD质控物检测结果比较,二者呈正相关(P>0.05),且变异系数CV%均小于15%。结论自行研制的液性质控血清具有时间稳定性良好,重复性好,成本低等优点,有推广于临床应用的潜质。

Objective To explore and prepare liquid quality control serum for clinical examination of tumor makers.Methods Self-made quality control serum were prepared by using routine serum as the starting material,and 30% ethylene glycol（Ethylene Glycol,EG）as stabilizer under the natural stratification process of dissolution.Two levels of AFP,CEA,CA125,CA153,CA199 and three levels of T-PSA,NSE,β-HCG,CA-724,CY2-11were produced in this study.The stability of self-made quality control serum were compared by lyophilized control material from BIO-RAD.Results Good correlation was found from the results of selfmade quality control serum and BIO-RAD quality control（P＆gt;0.05）,the coefficient of variation was less than 15%.Conclusion From the results above,the self-made quality control serum has advantages of a time good stability,good repeatability,and low cost,which is the potential for clinical application.