Zhang Zhen-Lu, Chen You-Ping, Tao Cui-Hua, Liu Xiao-Hui, Li Meng-Ya, Zhou Xin
Department of Laboratory Medicine, Zhongnan Hospital of Wuhan University, Wuhan, 430071, China.
Department of Pathology, Wuhan Asia Heart Hospital of Wuhan University, Wuhan, 430022, China.
J Huazhong Univ Sci Technolog Med Sci. 2016 Aug;36(4):614-617. doi: 10.1007/s11596-016-1634-3. Epub 2016 Jul 28.
Sonoclot analyzer has been widely used in many countries. But the reference intervals provided by the manufacturer were derived from only 45 participants, and there was no cut-off value for transfusion for Sonoclot analysis. This study aimed to establish reference intervals and transfusion criterion for Sonoclot analysis. Volunteers were recruited from healthy Chinese adults and patients undergoing cardiac surgery. Blood samples were withdrawn from forearm vein and measured for activated clotting time (ACT), clot rate (CR), platelet function (PF), activated partial thromboplastin time (APTT), fibrinogen concentration (FIB), and platelet count (PLT). The reference intervals were determined by the nonparametric method. Cut-off values were determined by the receiver operating characteristics curve. A total of 135 healthy volunteers and 281 patients were enrolled. The 95% reference intervals were 96-195 s, 22-51 signal U/min, >1.6 for ACT, CR, PF respectively. In the 281 patients, the results of APTT, FIB, PLT, ACT, CR, and PF ranged from 20.5-300.0 s, 0.28-4.11 g/L, (19.0-387.3)×109/L, 80-514 s, 2.9-74 signal U/min, and 0.1-5.1 respectively. The cut-off values for transfusion were >208, ≤14, and ≤1.3 for ACT, CR, PF respectively. The cut-off values of Sonoclot analysis were within the manufacturer's reference intervals, while they were outside the reference intervals established in this study. The results suggested that the manufacturer's reference intervals were not suitable for Chinese. The reference intervals and cut-off values established in this study will be helpful to Chinese patients.
Sonoclot分析仪已在许多国家广泛使用。但制造商提供的参考区间仅来自45名参与者，且Sonoclot分析没有输血的临界值。本研究旨在建立Sonoclot分析的参考区间和输血标准。从健康中国成年人和接受心脏手术的患者中招募志愿者。从前臂静脉采集血样，检测活化凝血时间（ACT）、凝血率（CR）、血小板功能（PF）、活化部分凝血活酶时间（APTT）、纤维蛋白原浓度（FIB）和血小板计数（PLT）。参考区间采用非参数方法确定。临界值通过受试者操作特征曲线确定。共纳入135名健康志愿者和281名患者。95%参考区间分别为ACT 96 - 195秒、CR 22 - 51信号单位/分钟、PF＞1.6。在281名患者中，APTT、FIB、PLT、ACT、CR和PF的结果分别为20.5 - 300.0秒、0.28 - 4.11克/升、（19.0 - 387.3）×10⁹/升、80 - 514秒、2.9 - 74信号单位/分钟和0.1 - 5.1。输血的临界值分别为ACT＞208、CR≤14和PF≤1.3。Sonoclot分析的临界值在制造商的参考区间内，但在本研究建立的参考区间外。结果表明，制造商的参考区间不适用于中国人。本研究建立的参考区间和临界值将对中国患者有帮助。
