血栓弹力图检测室内质量控制体系的建立

To establish the internal quality control system of Thromboelastography detection

目的探讨适合血栓弹力图检测的室内质量控制体系,建立并按体系规则执行室内质控。方法参照IFCC和NCCLS C24-A2标准方法,对2个水平的室内质控品进行血栓弹力图检测,确定质控品的血栓弹力图检测主要参数R值、K值、α角、MA值的均值、标准差sd、变异系数cv。以均值为中心线,±2sd为警戒限、±3sd为失控限,制作室内L-J（Levey-Jennings）质控图,分析L-J质控图,判断及分析失控原因。结果 TEG主要参数R值、K值、α角、MA值Ⅰ水平质控品的均值为1. 28、0. 80、83. 13、51. 43;标准差sd为0. 08、0. 00、0. 47、1. 14;变异系数cv为：6. 51%、0. 00%、0. 57%、2. 22%; ＋2sd为：1. 44、0. 80、84. 07、53. 71;-2sd为：1. 12、0. 80、82. 19、49. 15; ＋3sd为：1. 52、0. 80、84. 54、54. 85;-3sd为：1. 04、0. 80、81. 72、48. 01;Ⅱ水平质控品的均值为：1. 25、0. 84、79. 50、33. 56;标准差sd为0. 07、0. 05、0. 62、0. 68;变异系数cv为：5. 51%、5. 86%、0. 78%、2. 01%; ＋2sd为：1. 39、0. 94、80. 74、34. 92;-2sd为：1. 11、0. 74、78. 26、32. 20; ＋3sd为：1. 46、0. 9、81. 36、35. 60;-3sd为：1. 04、0. 69、77. 64、31. 52。两水平质控的cv值均在1/2允许总误差范围内。以为中心线,±2sd为警告限,±3sd为失控限绘制L-J质控图,两水平质控均无失控。结论血栓弹力图检测尙无系统的室内质量控制体系,我们参照IFCC和NCCLS C24-A2标准建立的血栓弹力图检测室内质控体系可以对血栓弹力图检测室内质控进行规范、科学、合理的评价。

Objective To explore and establish a suitable internal quality control system of thromboelastography（ TEG）detection. Methods Referencing IFCC and NCCLS C24-A2 standard methods,the two levels of the internal quality control were used for TEG,determine the parameter settings of 、sd、cv R、K、α、MA. L-J（ Levey-Jennings） chart was constructed with the being the mid line,±2 sd being the limit of the alert,± 3 sd being the limit of failing control. Analysis was performed based on the L-J（ Levey-Jennings） chart and the cause of control fails were analyzed.Results Main parameter R、K、α、MA of level I control mean ： 1. 28,0. 80,83. 13,0. 80; sd： 0. 08,0. 00,0. 47,0. 00; CV： 6. 51%,0. 00%,0. 57%,0. 00%;＋2 sd： 1. 44,0. 80,84. 07,53. 71; -2 sd： 1. 12,0. 80,82. 19,49. 15; ＋3 sd： 1. 52,0. 80,84. 54,54. 85; -3 sd： 1. 04,0. 80,81. 72,48. 01; level II control ： 1. 25,0. 84,79. 50,0. 84; sd： 0. 07,0. 05,0. 62,0. 05; CV： 5. 51%,5. 86%,0. 78%,2. 01%.＋2 sd： 1. 39,0. 94,80. 74,34. 92; -2 sd： 1. 11,0. 74,78. 26,32. 20; ＋ 3 sd： 1. 46,0. 9,81. 36,35. 60; -3 sd： 1. 04,0. 69,77. 64,31. 52.CV of the two standards of quality control were both within 50% of allowed error and were both within the control limit. Conclusion There is no internal quality control system of TEG detection,we established an internal quality control procedure according to the IFCC and NCCLS C24-A2 standards,which can complete the evaluation of TEG internal quality control Specification scientifically and reasonably.