野战(应急)快速检验系统的性能评价

Performance Evaluation of Biochem POCT Solutions

目的:评价北京倍肯公司研发的野战(应急)快速检验系统的基本性能。方法:对野战(应急)快速检验系统的血细胞分析模块、生化分析模块和尿液分析模块分别在室内环境与模拟野战环境下进行精密度评价,并对其在2种不同环境下检测结果进行对比。结果:血细胞分析模块HCT、Hb、WBC、PLT与生化分析模块ALT、BUN、GLU在室内和模拟野战环境下的变异系数(CV)均小于1/4 CLIA′88;尿液分析模块所有项目测定值与靶值的符合率均为100%。对血细胞分析模块(HCT、Hb、WBC、PLT)、电解质分析模块(Na+、K+、iCa2+)和生化分析模块(ALT、BUN、GLU)在室内与模拟野战环境的检测结果采用配对t检验进行比较,P值均>0.05;尿液分析模块URO、GLU、PRO、BIL、BLD、LEU、PH、SG、KET环境对比实验的Kappa值分别为0.66、0.94、0.91、0.94、0.93、0.92、0.81、0.76、1。结论:在室内、模拟野战环境下,野战(应急)快速检验系统的血细胞分析模块、生化分析模块和尿液分析模块精密度良好,2种环境下结果对比无显著差异。

Objective To evaluate the performance of Biochem POCT Solutions.Methods The precisions of the blood cell analysis module,biochemical analysis module and urine analysis module of Biochem POCT Solutions were estimated in indoor environment and simulated field environment,and the results were compared in the two environments.Results The variation coefficients（CVs）of HCT,Hb,WBC,PLT,ALT,BUN and GLU were less than 1/4 CLIA＇88,and the compliance rate of the measured values and the target value of urine analysis module was 100% indoor or in simulated field environment.There were no significant difference in HCT,Hb,WBC,PLT,Na＋,K＋,iCa2＋,ALT,BUN and GLU（P0.05）,and the kappa value of URO,GLU,PRO,BIL,BLD,LEU,PH,SG and KET were 0.66,0.94,0.91,0.94,0.93,0.92,0.81,0.76 and 1 between the two environments.Conclusion Blood cell analysis module,biochemical analysis module and urine analysis module of Biochem POCT Solutions have good precisions indoor or in simulated field environment,and results have no significant difference or show good consistency between the two environments.