冷冻分离技术在肿瘤标志物质控品研制中的应用

目的采用冷冻分离技术进行肿瘤标志物室内质控品的制备,并对其性能进行评价。方法收集常规检测标本中无传染性的剩余血清,采用冷冻分离技术制备不同水平的甲胎蛋白(AFP)、癌胚抗原(CEA)、总前列腺特异性抗原(TPSA)质控品,并根据CNAS-GL03标准对自制质控品的稳定性和均匀性进行分析。结果稳定性分析结果表明,自制质控品的稳定时间可达12个月,各样品间差异无统计学意义(P>0.05);均匀性分析结果表明,自制质控品的样品间和样品内测定结果差异无统计学意义(P>0.05)。结论采用冷冻分离技术所研制的肿瘤标志物质控品具有良好的均匀性及稳定性,在临床实验室可用于室内质控。

Preparation of quality control material for tumor maker by freezing separation technology

Objective To explore the preparation of an internal quality control material for tumor maker by adopting freezing separation technology,and then to investigate its performance.Methods Pooled routine noninfectious residual serum was used as the medium for the quality control material for alpha-fetoprotein(AFP),carcinoembryonic antigen(CEA),total prostate-specific antigen(TPSA)preparation.By adopting freezing separation technology,quality control materials with different tumor maker levels were prepared.The homogeneity and stability of the preparations were evaluated according to the CNAS-GL03.Results In the stability evaluation of preparations,the results showed that the stable period of the preparations was 12 months and there was no significant difference between samples(P>0.05).In the homogeneity evaluation of preparations,the results showed that the differences within samples and between samples were not significant(P>0.05).Conclusion The prepared tumor maker control material with freezing separation technology have sound homogeneity and stability,which could be applied for the internal quality control in clinical laboratories.