PL-11血小板分析仪检测功能的性能评价  

Performance evaluation of PL-11 platelet analyzer

作　　者：张有涛[1] 赵益明[2] 季顺东[2] 赵赟霄[2] 蒋敏[1] 金晓华[1] 史进方[1] 顾国浩[1] 阮长耿[2] 

机构地区：[1]苏州大学附属第一医院检验科,215006 [2]苏州大学附属第一医院江苏省血液研究所卫生部血栓与止血重点实验室

出　　处：《中华检验医学杂志》2012年第12期1139-1141,共3页Chinese Journal of Laboratory Medicine

摘　　要：目的评价PL-11血小板分析仪的分析性能。方法用EDTA．K2及柠檬酸钠静脉抗凝血，测试PL-11血小板分析仪的批内重复性、日间重复性、携带污染率、准确性及线性性能，并选择2012年2月至7月苏州大学附属第一医院门诊30位体检者的空腹柠檬酸钠静脉抗凝血与MPG-3E多功能双通道血液凝聚仪测定结果进行相关分析。结果各参数皆符合ELIA’88法案的要求。PL．11血小板分析仪批内、日间精密度的CV均〈5％；携带污染率〈1％；测定定值全血质控物，准确性满意，线性良好；测定结果与光电比浊法结果相关性分析，R2=0．9439。结论PL-11血小板分析仪可直接使用全血动态分析血小板聚集过程并能对血液细胞的多种组分（包括血小板和红细胞）进行定量分析，报告结果准确可靠。Objective To evaluate and report the performance of PL-11 platelet analyzer. Methods Intravenous blood samples anticoagulated with EDTA-K2 and sodium citrate were tested by the PL-11 platelet analyzer to evaluate the intra-assay and inter-assay coefficient of variation （CV） , carry-over rate, accuracy, linearity of the PL-11 platelet analyzer. Platelet aggregation rate of sodium citrate-anticoagulated fasting venous blood collected from 30 physical examinees in outpatient department of The First Affiliated Hospital of Soochow University between February and July, 2012 was detected by the PL-11 platelet analyzer and MPG- 3E multifunctional double channel blood coagulation analyzer, respectively. The correlation was detected between the PL-11 platelet analyzer and MPG-3E multifunctional double channel blood coagulation analyzer. Results All the parameters were conformed to the standard of Clinical Laboratory Improvement Amendment 88. Both of the intra-assay and inter-assay CV values were less than 5% ; carry-over rate was less than 1% ; the accuracy and the linearity was excellent correlated to the result of photoelectric turhidimetry （ R2 = 0. 9439 ）. Conclusions PL-11 platelet analyzer can directly use whole blood dynamics to analyze platelet aggregation process and quantitatively analyze the various components of blood cells （including platelets and red blood cells）, the result reports are accurate and reliable.

关 键 词：血小板聚集 血小板功能试验 诊断设备 评价研究 

分 类 号：R446.1[医药卫生—诊断学]