病理水平D-二聚体室内质控品的制备及应用评价

Preparation and application evaluation of indoor quality control plasma of pathological level D-Dimmer

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 indoor quality control plasma of pathological level D-Dimmer, and to evaluate its application value. Methods To choose pooled plasma of pathological level D-Dimmer to produce indoor quality control plasma, by using D-Dimer medium composition as preservation medium, which includes Aprotinin with 25 mmol/L and pH=7.4 PBS, sucrose of 60 g/L, Carbowax of 20 g/L, calf serum albumin of 10 g/L, sodium azide of 0.5 g/L. To compare the quality control effect of the self-made quality control product and SIEMENS quality control product by using L-1 quality control chart. To check the stability of the self-made quality control plasma produced by storing it under the room temperature, 4℃ and -20℃. Results The setting value of the self-made quality control product of pathological level D- Dimmer is 4.13 mg/L. The self-made quality control product, which can monitor the incontrollable of reagent, instrument, environment and other factors, has the same quality control effect as the SIEMENS quality control product. The self-made quality control product can be stable for 8 months under the temperature of -20℃, it must be used in 2 hours under the room temperature or 2 days under the temperature of 4℃ after being melted. Conclusion The stability and quality control effect of the self-made quality control product of pathological level D-Dimmer are in line with the requirements of indoor quality control product, and it can be used in laboratory quality control.