Application of self-made quality control materials on chemiluminescence analyzer / 国际检验医学杂志

ABSTRACT

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 .