兔血浆应用于部分凝血活酶时间（PTT）试验以评价医疗器械促凝活性的研究  

Study on Rabbit Plasma Applied to Partial Thromboplastin Time (PTT) Test to Evaluate the Procoagulant Activity of Medical Devices

作　　者：杨文润[1] 莫晓彦 颜林[1] 田胜慧 曹穗兰 杨立峰[1] YANG Wen-run;MO Xiao-yan;YAN Lin;TIAN Sheng-hui;CAO Sui-lan;YANG Li-feng(Guang dong Medical Devices Quality Surveillance and Test Institute,Guangdong Guangzhou 510080)

机构地区：[1]广东省医疗器械质量监督检验所

出　　处：《中国医疗器械信息》2020年第1期24-26,共3页China Medical Device Information

基　　金：广东省医疗器械质量监督检验所检验技术创新项目（项目名称：医疗器械体外血栓形成试验的方法研究，项目编号：GDMDTKYXM-2018A01）

摘　　要：目的:探究兔血浆应用于PTT试验以评价医疗器械促凝活性的可行性。方法:以ASTM F2382-04标准为研究基础,选择5种医疗器械或材料,在同一试验条件下,分别使用人血浆和兔血浆进行PTT试验。结果:对两种血浆的PTT试验结果进行促凝活性分级,除玻璃珠组的促凝血活性分级有差异外,其他4种医疗器械或材料的促凝活性分级均为:重度、中度、轻度、极轻。结论:兔血浆和人血浆的PTT试验具有良好的一致性,当人血浆来源不足时,兔血浆可作为一种比较理想的血浆来源应用于PTT试验以评价医疗器械的促凝活性。Objective: Explore the feasibility of applying rabbit plasma to the PTT test to evaluate the procoagulant activity of medical devices. Methods: Based on the ASTM F2382-04 standard, five medical devices or materials were selected. Under the same test conditions, human plasma and rabbit plasma were used for PTT tests. Results: The test results of the two plasmas were graded for the procoagulant activity. except for the difference in the procoagulant activity grade of the glass bead group, the procoagulant activity ratings of the other four medical devices or materials were consistent, and the grades were: Activator, Moderate activator, Mild activator, Minimal activator. Conclusion: The PTT test of rabbit plasma and human plasma has good consistency. When the source of human plasma is insufficient, rabbit plasma can be used as an ideal plasma source to evaluate the procoagulant activity of medical devices.

关 键 词：激活剂 医疗器械 部分凝血活酶时间 促凝活性 

分 类 号：R197.39[医药卫生—卫生事业管理]