SYSMEX CS5100血凝分析仪性能评估及凝血六项参考区间的调整

Performance evaluation and reference range adjustment for 6 coagulation indicators of SYSMEX CS5100 coagulation analyzer

目的评估本实验室SYSMEX CS5100全自动血凝分析仪（简称CS5100）的性能,验证厂家推荐的凝血指标参考范围,并建立适用于本实验室的参考区间。方法应用CS5100检测混合血浆、质控品和222名健康体检者血浆样本的凝血酶原时间（PT）、活化部分凝血活酶时间（APTT）、凝血酶时间（TT）、纤维蛋白原（FIB）、D-二聚体（DD）和纤维蛋白原降解产物（FDP）。结果按照国际血液学标准化委员会（ICSH）制定的技术方案,仪器的精密度、准确度、线性范围、携带污染等性能指标评价良好。厂家提供的TT、DD和FDP的参考区间经验证均适用于本实验室,重新建立的PT、APTT、FIB的参考区间分别为10.4~13.0 s、19.5~30.3 s、1.6~3.6 g/L。不同性别间凝血各指标的差异均无统计学意义（P〉0.05）。结论在保证仪器性能指标均为正常的基础上,验证和建立了适合本实验室的性能评价指标,符合本实验室的参考区间,为临床提供更精准的检验结果。

Objective To evaluate the performance of SYSMEX CS5100 automatic coagulation analyzer( CS5100),verify the reference ranges of coagulation indicators recommended by manufacturers,and establish our own laboratory reference ranges. Methods The prothrombin time( PT),activated partial thromboplastin time( APTT),thrombin time( TT),fibrinogen( FIB),D-dimer( DD) and fibrinogen degradation product( FDP) were determined in mixed plasma,quality control plasma and plasma from 222 healthy subjects by CS5100. Results According to the technical program by the International Council for Standardization in Haematology( ICSH),the analyzer had high precision,accuracy,good linear range and low carryover rate. The recommended reference ranges of TT,DD and FDP were appropriate for our laboratory. The reference ranges of PT,APTT and FIB( 10. 4-13. 0 s,19. 5-30. 3 s and 1. 6-3. 6 g /L) were established statistically. There was no statistical significance between male and female groups on the coagulation indicators( P > 0. 05). Conclusions In the basis of ensuring a good condition of CS5100,the reference ranges of coagulation indicators for our own laboratory are established and verified,which may provide accurate results for clinic.