CA-7000血凝分析仪性能评估及临床参考范围建立

Performance Assessment of CA-7000 Coagulation Analyzer and Establishment of Reference Ranges for Coagulation Indicators

目的评估本实验室sysmex CA-7000全自动血凝分析仪的性能,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范围。方法应用日本sysmex CA-7000全自动血凝分析仪检测混合血浆、质控品和360例健康体检者血浆样本的PT、APTT、TT和FIB凝血项目。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、携带污染以及抗干扰能力等性能评价良好。厂家提供的PT、APTT和TT的参考值经验证均适用于本实验室,用统计学处理建立了FIB的参考值为(1.7～4.0)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具体实验条件,符合本实验室的参考值范围,为临床提供更精准的检验结果。

Objective To evaluate the performance of sysmex CA-7000 fully automated coagulation analyzer in the laboratory,verify the reference ranges of coagulation indicators recommended by manufacturers and establish our own laboratory reference ranges.Methods PT,APTT,TT and FIB were measured in mixed plasma,quality control plasma and 360 healthy adults plasma specimens by sysmex CA-7000.Results According to the technical program released by the International Council for Standardization in Haematology(ICSH),the instrument had high precision and accuracy,a good linear range,low carrying stain rate and high capability of anti-interference.The recommended reference ranges of PT,APTT,TT were appropriate for our laboratory.Then the reference range of FIB was calculated as(1.7～4.0) g/L by statistical method separately.There was no significant difference between male and female groups on the coagulation indicators.Conclusions In the basis of ensuring a good condition of CA-7000 coagulation analyzer,we establish the reference range of coagulation indicators for our own laboratory which may provide accurate results for clinic.