手持式血酮体测试仪的临床评价  

Clinical evaluation of the performance of portable blood ketone monitor

作　　者：董振南[1] 张丹[1] 刘红艳[2] 李元光 孙晓亮 何伟 

机构地区：[1]中国人民解放军总医院生化科,北京100853 [2]中国人民解放军总医院综合治疗室,北京100853 [3]北京怡成生物电子技术有限公司,北京100016

出　　处：《分析仪器》2008年第3期55-58,共4页Analytical Instrumentation

基　　金：国家863项目课题<便携式全血分析微系统实用化研究>;课题编号:2004AA404021

摘　　要：目的:对国产手持式T-Ⅰ型血酮体测试仪进行临床评价。方法:系统评价仪器的准确度、精密度、可报告范围,并与常规生化分析仪的酶法进行方法学比较试验以及确定参考范围。结果:标准电阻条测量结果的偏差均小于5%,4个不同水平的全血β-羟丁酸标本回收率为89.1%～93.8%;低高2个水平全血标本检测结果CV分别为8.25%和3.01%;检测系统可报告范围为0.3～6.0 mmol/L;三个批号试条的批间差为7.6%;方法与酶动力学法结果之间具有良好的相关性(r=0.9933);该系统测试健康人群末梢全血酮体参考范围<0.3 mmol/L。结论:国产手持式T-Ⅰ型血酮体测试仪进行全血酮体检测具有良好的准确性和重复性,适宜临床常规检测及家庭自我监测。Objective： To evaluate the performance of T-1 portable blood ketone monitor in clinical use. Methods： The accuracy, precison and reportable range of the instrument were tested and the instrument was compared with conventional enzyme method of biochemical analyer methodologically. The reference range was determined. Results： Deviations of standard resistor measurement results were less than 5 %. The recoveries of four levels of whole blood standard solution （β-hydroxylbutyrate） samples were 89. 1% 93.8%. The CVs of low level and high level standard solution samples were 8.25% and 3.01%, respectively. The reportable range was 0. 3 -6. 0 mmol/L. The variation among three different lots of test stripes was 7.6%. The results showed good correlation with enzyme method （r=0. 9933）. The reference range of capillary whole blood ketone of health people was 〈0.3 mmol/L. Conclusion： T-1 portable blood ketone monitor has good accuracy and reproducibility and is suitable for clinical routine test and self-monitoring.

关 键 词：血酮体测试仪 Β-羟丁酸 临床评价 

分 类 号：TH776[机械工程—仪器科学与技术]