自制甲氨蝶呤质控血清在均相酶免疫法测定血药浓度中的应用

Application of Self-Made Methotrexate Quality-Control Serum in Therapeutic Durg Monitoring Using Homogeneous Enzyme Immunoassay Method

目的评价自制甲氨蝶呤质控血清在均相酶免疫法测定血药浓度中的应用。方法取注射用甲氨蝶呤5mg，注射用水溶解后加入血清基质液，制备浓度分别为0．44，1．10，1．54μmol／L的甲氨蝶呤质控血清，考察方法准确性、重复性、质控的稳定性以及临床应用。结果自制低、中、高浓度的甲氨蝶呤质控血清检测结果为靶值的97．7％～99．1％，方法重复性RSD小于2％，-30℃保存90天含量变化小于2％。结论自制甲氨蝶呤质控血清操作方法简单、成本低、结果准确可靠，-30℃保存90天可以作为实验室日常质控应用。

Objective To evaluate self-made methotrexate quality-control serum in therapeutic durg monitoring using homoge- neous enzyme immunoassay method. Methods 5 mg methotrexate for injection was dissolved by water and then mixed with blank serum. The preparation, repeatability, sample stability and clinical application were studied. Results The results of low,medium and high concentration of methotrexate quality-control serum was between 97.7 %- 99.1 %. RSD of method repeatability was less than 2%. The content change of methotrexate was less than 2% while saved at -30℃ for 90 days. Conclusion The method for preparation of self made methotrexate quality-control serum is simple,cost-effective,accurate and reliable,which can be used as daily laboratory quality control while saved at -30℃.