自制质控品在化学发光仪上的应用  

Application of self-made quality control materials on chemiluminescence analyzer

作　　者：董莉[1] 易青[1] 杜肖彦[1] 

机构地区：[1]内蒙古医科大学附属医院检验科,内蒙古呼和浩特010059

出　　处：《国际检验医学杂志》2014年第9期1172-1174,共3页International Journal of Laboratory Medicine

摘　　要：目的探讨自制质控品在化学发光仪上应用的可行性。方法收集血袋中残余的血清作为基质血清。制备肿瘤标记物[癌胚抗原、甲胎蛋白、糖链抗原125(CA125)、CA199、CA153、人绒毛膜促性腺激素、总前列腺特异性抗原]及激素类标记物(促黄体生成激素、促卵泡成熟激素、雌二醇、睾酮、孕酮及泌乳素)复合质控品,统计12个月各项目的月均值、变异系数(CV)%值、累计均值、CV%值和失控次数。结果所有分装保存的自制质控血清冻融后外观清澈、透明,未见浑浊及沉淀。上述项目月平均值、累计平均值的差异无统计学意义(P>0.05),上述项目月平均值与累计平均值比较,未见显著漂移及趋势变化。激素各项目每月室内不精密度均控制在允许范围内。1年中监测到失控报警36次,其中,系统误差25次,随机误差11次。结论自制质控品具有良好的稳定性,能及时发现检测系统的不稳定性因素,确保化学发光仪检测结果的可靠性。Objective To investigate the feasibility of self-made quality control materials on chemiluminescence analyzer .Meth-ods Residual serum in blood bags were collected and served as matrixes .Complex quality control materials of tumor markers [car-cinoembryonic antigen ,alpha-fetoprotein ,carbohydrate antigen 125（CA125） ,CA199 ,CA153 ,human chorionic gonadotrophin and total prostate specific antigen ] and hormonal markers （luteinizing hormone ,follicle-stimulating hormone ,estradiol ,testosterone , progesterone and prolactin） were prepared .The monthly average value ,coefficient of variation（CV）% value ,cumulative average value and the number of out-of-control of each marker during the 12 months were calculated .Results All self-made quality control serum which stored and packaged separately showed appearance of clear and transparent after freezing and thawing ,without turbidi-ty and sedimentation .Difference of monthly average value and cumulative average value of each marker had no statistical significance （P〉0 .05） .Compared with monthly average value and cumulative average value of each marker ,no obvious drift and trends were found .Monthly indoor imprecision of each hormonal marker were controlled within the allowable range .36 times of out-of-control alarm were monitored during a year ,among them ,25 for system error and 11 for random error .Conclusion Self-made quality con-trol materials has good stability and may find the instability factors of detection system timely to guarantee the reliability of test re-sults of chemiluminescence analyzer .

关 键 词：肿瘤标记 生物学 激素类 质控品 

分 类 号：R446[医药卫生—诊断学]