全自动凝血分析流水线HIL指数报警阈值和体积探测允许范围的初步建立

Preliminary establishment of HIL alert indices and allowable ranges of sample volume for automatic coagulation analysis line in laboratory

目的 初步建立CS5100和CN6000全自动凝血分析仪溶血、黄疸和乳糜(HIL)报警指数及标本体积探测允许范围。方法 干扰标本由干扰物试剂盒配制或人工溶血方式获得。21例不同浓度干扰标本用于仪器HIL指数重复性验证,206例不同浓度干扰标本用于系统间HIL指数一致性验证。收集425例标本评估不同HIL指数时干扰物浓度分布,378例标本评估人工判断与仪器HIL指数等级一致性。测定人工制备干扰前后标本凝血筛查6项及HIL指数,比较不同干扰物浓度区间检测结果间差异,确定每个项目不同检测区间的HIL指数报警阈值。制备标准体积±10%上下限标本各10管,建立每台仪器体积探测允许范围并使用2 933例标本进行验证。结果 2个检测系统HIL指数重复性良好,系统间一致性较好(Kappa值分别为0.969、0.978和0.991,P值均为0.000)。仪器和人工判断对溶血标本评价存在一致性,但一致性一般(Kappa值为0.421~0.702,P均<0.001);仪器和人工判断对黄疸标本判断一致性较差(Kappa值为0.023~0.267,人员1与仪器之间P=0.258,余P均<0.001);仪器和人工判断对乳糜标本判断一致性较好(Kappa值为0.559~0.838,P均<0.001)。每个项目不同检测区间HIL指数报警阈值不同,用于普通肝素抗凝监测时APTT H报警指数明显低于其他项目。5台凝血分析仪体积探测允许范围分别为41.0~55.5 mm、44.3~58.4 mm,41.3~56.2 mm,58.3~72.5 mm和59.2~73.3 mm。结论 初步确定了适用于本实验室两个检测系统出凝血筛查项目不同检测区间HIL指数阈值和体积探测允许范围,为实现全面的分析前质量控制智能化管理提供依据。

Objective To establish hemolysis-icterus-lipemia(HIL) alert indices and allowable ranges of sample volume check in CS5100 and CN6000 automated coagulation analyzers.Methods The samples of interference substances were prepared by using the interference reagent kit or obtained through artificial freeze and suction.Twenty-one samples with various concentrations of interference substances were used to evaluate repeatability of HIL indices,and 206 such samples were used to evaluate the consistency of HIL indices between two different instrument systems.A total of 425 specimens were collected to evaluate the concentration distribution of interfering substances with various HIL indices,and 378 specimens were used to evaluate the consistency of HIL indices between manual assessment and instrumental operation.Six coagulation screening tests were analyzed parallelly for the samples prepared with the artificial interference before and after,and the HIL indices were recorded.The differences between the paired samples with different concentrations of interference substances were compared,and the HIL alert indices in different detection intervals of each test were determined.Ten tubes of samples with standard volume ±10% lower and upper limits were prepared using distilled water to establish the allowable range of volume check for each instrument,and 2 933 samples were used to validate the established ranges.Results The repeatabilities of the HIL indices in the two systems were favorable,and the consistency between the two systems was fine(Kappa values were 0.969,0.978 and 0.991,respectively,P=0.000).The consistency between instrumental and manual assessment for the evaluation of hemolytic samples was just average level(Kappa values were 0.421 to 0.702,P<0.001).The consistency for jaundice samples between instrumental and manual assessment was poor(Kappa values were 0.023 to 0.267),except the P=0.258 between the operator 1 and instrument,all the other operators were remaining P<0.001.The consistency between instrumental and manual assessment for chyle samples was better(Kappa values 0.559 to 0.838,P<0.001).The HIL alert indices varied with different intervals of detection for each test.The APTT H alert index was significantly lower than that measured in other tests when ordinary heparin was used in anti-coagulation monitoring.The allowable ranges of volume check in 5 coagulation analyzers were 41.0 to 55.5 mm,44.3 to 58.4 mm,41.3 to 56.2 mm,58.3 to 72.5 mm and 59.2 to 73.3 mm respectively.Conclusion The HIL alert indices and allowable range of volume check were determined preliminarily for coagulation screening tests in various detection intervals of two different systems in our laboratory,which provided the basis for achieving intelligent management of pre-analytical quality control.