国产全自动生化分析仪自建检测系统的临床应用评价

The evaluation of the clinical measurement characteristic of domestic automatic biochemical analyzer using the self-developed system of the analyzer

目的对国产英诺华D-280自建生化检测系统部分性能进行验证,并与进口检测系统的检测结果进行比对和偏倚评估,探讨国产仪器自建检测系统的临床应用价值。方法依据国家相关规定对丙氨酸转氨酶(ALT)、尿酸(UA)、肌酐(Cr)、尿素(Urea)、胆固醇(TC)、三酰甘油(TG)、血糖(Glu)等项目进行精密度、线性范围验证,交叉污染以血糖为例进行评估,并依据美国临床实验室标准化委员会(NCCLS)的EP9-A2文件与贝克曼检测系统作患者比对分析。结果各项目的精密度均达到厂家声明;血糖交叉污染率为1.06%,达到临床使用要求;线性范围除Glu外均达到厂家声明,Glu浓度超过11.1mmol/L时出现结果偏低现象;患者结果比对分析,两系统间的相关系数均>0.975,医学决定水平偏倚评估ALT、UA、Ure、Glu低值水平处偏倚大于1/2CLIA'88小于CLIA'88允许误差范围,Cr低值水平处偏倚大于其浓度水平CLIA'88允许误差范围,由于其浓度在异常医学决定水平处,其低值在临床又缺乏实际的意义,因此临床可以接受,其余项目偏倚临床均可接受。结论国产英诺华D-280自建生化检测系统性能基本达到临床使用要求,能满足基层医院作为健康筛查、初步诊断之用。

Objective To evaluate the part of the self-developed system of domestic automatic biochemical analyzer, INNOVA-D-280, and its clinical application by method of comparison and bias estimation with an imported analytical system. Methods The items including ALT, UA,Cr,Urea,TC,TG,GIu, etc. were evaluated by the precision and linear range in accordance to the national stipulation. Glu was chosen and evaluated by crossing contamination. And the samples of patients were comparatively measured in accordance to the document EP9-A2 of NCCLS and Backman analytical system. Results The precision of all items were consistent with the statement of the manufacturer and the nation; the Glu crossing contamination rate was 1.06%, which consistent with the clinical application request. The linear range was consistent with the statement of the manufacturer except Glu, when Glu density was over 11.1mmol/L, the result was low. The relative coefficients of comparative analyze of the patients were both over 0.975. The bias at clinical decision of ALT, UA, Ure, Glu were over 1/2 CLIA＇88 and less than the permitted error range of CLIA＇88. The low level of Cr was more than its level of density, because the density was in the abnormal determined medicine level. The low level was lack of the practical value in clinical application, so it can be accepted. And the other items can be accepted by bias clinical application. Conclusion The measurement characteristic of evaluated domestic INNOVA-D-208 self -developed biochemical analyzer system can fit in with the clinical application request, the health screening, and the initial diagnosis of the primary hospital.