凝血分析仪检测研制样品ATⅢ活性的适用性研究

The study of using coagulation analyzer to detect the Antithrombin activity of ATⅢ process samples

目的确认采用全自动凝血分析仪及配套检测试剂盒检测ATⅢ制备过程样的ATⅢ活性的适用性。方法以ATⅢ工作参考品、Serpins血浆参考品、ATⅢ质控品及ATⅢ研制过程样作为测试样品,采用ACL7000检测ATⅢ活性,考察其准确性、精密度、线性和粗放性。结果 ACL7000检测ATⅢ活性的回收率在1.01-1.05之间;精密度在1.6%-4.1%之间、中间精密度在2.5%-2.9%;Serpins血浆参考品的直线回归系数r=0.997 6-1.000 0;ATⅢ工作参考品的直线回归系数r=0.977 4-0.998 6;对同一S/D过程样品原倍和对倍稀释后的检测结果进行成对t检验,P>0.05,两组数据差异无统计学意义。结论使用凝血分析仪及配套试剂盒进行ATⅢ活性检测可以满足ATⅢ制备过程中对活性的在线检测需要。

Objective To confirm the applicability of using coagulation analyzer ACL7000 and ancillary detection Kit to detect the Antithrombin activity of ATⅢ process samples. Methods Assay the Antithrombin activity of ATⅢ Working reference material,Serpins reference plasma,ATⅢ quality control material and process samples with ACL7000 respectively to investigate the accuracy,precision,linearity and robustness of method. Results The recovery,repeatability,intermediate precision are 1. 01- 1. 05; 1. 6%- 4. 1% and 2. 5%- 2. 9%respectively; Meanwhile the linear regression coefficients of Serpins reference plasma and AT Ⅲ Working reference material are 0. 997 6- 1. 000 0 and 0. 977 4- 0. 998 6 respectively. To compare the results of the same S / D process samples of 1 and 2 times dilution by paired t-test and p = 0. 190,which indicates without statistically significance about differences of the 2 group of data. Conclusion Using coagulation analyzer and ancillary detection Kit to detect Antithrombin activity can meet the need of online monitoring in the process of ATⅢ preparation.