国内厂家胱抑素C试剂的评价方法研究和结果分析

Research for evaluation methods s of cystatin C reagent among domestic manufacturers and their results analysis

目的定州市人民医院对国内多个厂家的胱抑素C(CysC)测定试剂的主要性能进行评估,了解其是否能满足临床需求。方法分别对不同厂家的试剂进行主要性能评价,并与国际优质的日本生研试剂进行对比。结果国内厂家的CysC试剂在稳定性、线性范围、临床比对、精密度、抗脂浊干扰、灵敏度方面都符合要求、并与进口的日本生研试剂有良好的相关性。结论国内新成生物的CysC检测试剂盒在主要性能方面符合临床应用要求。

Objective To conduct the main performance of cystatin C（CysC） detection reagent from different domestic manufacturers to know whether it can meet the clinical needs. Methods The performance evaluation to CysC reagents from different domestic manufacturers were performed and compared with the Japan＇s bio-research reagent. Results In the domestic manufacturers＇ CysC reagent, the stability, linear range, clinical comparison, preci sion, interference and sensitivity were in line with the requirements and had good correlation with Japan＇s bio-research reagent. Conclusion The main performance of the domestic CysC reagent fully meets the requirements of clinical applications.