论文部分内容阅读
目的研制病理水平的D-二聚体室内质控品,并对其稳定性和质控效果进行评估。方法用病理水平的D-二聚体混合血浆为血浆制备来源,以“抑肽酶、25 mmol/L的pH=7.4磷酸缓冲液、60 g/L蔗糖、20 g/L聚乙二醇2万衍生物、10 g/L小牛血清清蛋白、0.5 g/L叠氮钠”为保存介质制备D-二聚体质控品;采用L-J质控图比较自制质控品和西门子定值质控品的质控效果;观察自制质控品在室温、4℃、-20℃冰箱保存条件下的稳定性。结果自制病理水平D-二聚体质控品定值为4.13 mg/L;自制质控品与定值质控品质控效果一致,可监测到试剂、仪器、环境等因素引起的失控;自制质控品在-20℃冰箱保存条件下可稳定8个月,复融后须在室温2 h内、4℃冰箱2 d内使用。结论自制病理水平D-二聚体质控品的稳定性和质控效果均符合室内质控品的要求,可应用于实验室的室内质控。
Objective To develop pathological level D-dimer indoor quality control and assess its stability and quality control. Methods The pathological D-dimer mixed plasma was used as the source of plasma preparation, with “aprotinin, 25 mmol / L phosphate buffer pH 7.4, 60 g / L sucrose, 20 g / 20000 derivatives, 10 g / L bovine serum albumin, 0.5 g / L sodium azide ”for the preparation of D-dimer quality control media; LJ quality control using the comparison of homemade controls and Siemens value Quality control effect of quality control; observed homemade quality control at room temperature, 4 ℃, -20 ℃ refrigerator under the conditions of storage stability. Results The self-made D-dimer quality control was 4.13 mg / L. The self-made quality control was consistent with the quality control of the quality control. The quality control of D-dimer was self-contained, which could be controlled by reagents, instruments and environment. The product can be stable for 8 months under the condition of -20 ℃ refrigerator, after thawing, it must be used within 2 hours at room temperature within 2 hours and at 4 ℃ for 2 days. Conclusion The stability and quality control effect of homemade pathological D-dimer control products are in line with the requirements of indoor quality control products, which can be applied to laboratory quality control in laboratories.