摘要
目的就人绒毛膜促性腺激素(β-HCG)作为急诊项目在Roche Cobas e411电化学发光全自动免疫分析系统上的性能进行分析评估。方法根据美国临床和实验室标准化协会(CLSI)文件,中华人民共和国卫生行业标准WS/T408-2012《临床化学设备线性评价指南》,使用患者血清和室间质评物,通过β-HCG对仪器的精密度、准确度、线性及可报告范围与实验室内参考仪器进行比对,以评估同一项目在实验室检测结果是否具有一致性。结果使用患者混合血清完成β-HCG的精密度测定试验,批内精密度和总精密度CV值小于厂家声明的CV值;使用室间质评物完成准确度测定试验,5份质评物的检测结果与回报靶值的偏倚在9.8%~13.8%,均在室间质评的测量范围内;选取接近β-HCG检测上限的高值标本进行线性评估试验,显示数据组在0.1~9572 m IU/m L,具有临床可接受的非线性;临床可报告范围为0.1~957200 m IU/L。选择20个患者标本进行比对试验,计算与参考仪器间的绝对偏倚均<12.5%,比对通过。结论β-HCG在Roche Cobas e411电化学发光全自动免疫分析系统上的精密度、准确度符合要求,线性及可报告范围可满足临床应用。
Objective This paper aims to evaluate and analyze the performance of Roche Cobas e411 electrochemical luminescence full automatic immune system with β-HCG. Methods According to the clinical and laboratory standards institute （CLSI） fle and the People’s Republic of China health industry standard WS/T408-2012 linear evaluation guide clinical chemistry equipment, patients serum, ventricular interstitial material and β-HCG were used to evaluate precision, accuracy, linear reportable range of this machine by comparing the results of Roche Cobas e411 with reference instruments, in order to fnd whether they had the same results. Results Mixed serum in patients was used to complete the β-HCG precision test, and results showed that total CV value and CV value within the group were less than manufacturer statement CV value. External quality assessment was used to complete measurement accuracy test, the bias between 5 quality assessment and return target value were all in the range of 9.8%～13.8%, which were all in the range of external quality assessment. High value specimens which close to β-HCG superior limit were chosen to complete linear evaluation experiment, results showed that the data set were in the range of 0.1~9572 mIU/mL, with clinical acceptable nonlinear. 20 patients’ specimens were selected to do comparison test, absolute bias of calculation and reference instruments were less than 12.5%, results showed that the test was passed. Conclusion β-HCG tests in Roche Cobas e411 electrochemical luminescence full automatic immune system show that precision and accuracy of the machine meet the requirements, and linear and reportable range are acceptable in clinical.
出处
《中国医疗设备》
2017年第9期87-89,102,共4页
China Medical Devices
关键词
人绒毛膜促性腺激素
电化学发光全自动免疫分析系统
性能验证
精密度
准确度
线性
human chorionic gonadotropin
electrochemical luminescence full automatic immune system
performance verifcation
precision
accuracy
linear
