title: Establishment of reference intervals and transfusion criterion for Sonoclot analysis.
abstract: 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 Blood samples were withdrawn from forearm vein and measured for activated clotting time (ACT), clot rate (CR), platelet function (PF), activated partial thromboplastin time (APTT),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.
authors.affiliation: Department of Laboratory Medicine, Zhongnan Hospital of Wuhan University, Wuhan, 430071, China.
authors.forename: Zhen-Lu
authors.initials: ZL
authors.lastname: Zhang
authors.affiliation: Department of Pathology, Wuhan Asia Heart Hospital of Wuhan University, Wuhan, 430022, China.
authors.forename: You-Ping
authors.initials: YP
authors.lastname: Chen
authors.affiliation: Department of Transfusion, Wuhan Asia Heart Hospital of Wuhan University, Wuhan, 430022, China.
authors.forename: Cui-Hua
authors.initials: CH
authors.lastname: Tao
authors.affiliation: Department of Laboratory Medicine, Wuhan Asia Heart Hospital of Wuhan University, Wuhan, 430022, China.
authors.forename: Xiao-Hui
authors.initials: XH
authors.lastname: Liu
authors.affiliation: Department of Cardiology, Wuhan Asia Heart Hospital of Wuhan University, Wuhan, 430022, China.
authors.forename: Meng-Ya
authors.initials: MY
authors.lastname: Li
authors.affiliation: Department of Laboratory Medicine, Zhongnan Hospital of Wuhan University, Wuhan, 430071, China. whdxjykzx@163.com.
authors.forename: Xin
authors.initials: X
authors.lastname: Zhou
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D001777:Blood Coagulation; D002315:Cardiopulmonary Bypass; D002681:China; D005260:Female; D005340:Fibrinogen / Q000378:metabolism*; D006801:Humans; D008297:Male; D008875:Middle Aged; D010314:Partial Thromboplastin Time / Q000379:methods; D010976:Platelet Count; D019095:Point-of-Care Systems; D012016:Reference Values
chemical_list: D005340:Fibrinogen
keywords: Sonoclot analyzer; reference interval; transfusion criterion