手持式血酮体分析仪的临床评价  

Evaluation of a Portable Whole Blood Ketone Body Analyzer

作　　者：尹志农[1] 夏良裕[2] 鄢盛恺[2] 宋耀虹[2] 刘荔[2] 李元光 刘茜[2] 庞新 何伟 

机构地区：[1]北京垂杨柳医院实验中心,北京100022 [2]中国医学科学院中国协和医科大学北京协和医院检验科,北京100730 [3]北京怡成生物电子技术有限公司,北京100020

出　　处：《现代检验医学杂志》2007年第2期10-13,共4页Journal of Modern Laboratory Medicine

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T-1型国产手持式血酮体分析仪进行临床评价。方法 采用标准电阻条、标准β-羟丁酸（β-HB）溶液与新鲜静脉抗凝全血／指血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 标准电阻测量结果的偏差均小于5％，4个不同水平的全血pHB标本回收率为92．4％～96．3％；精密度试验：低高2个水平全血标本检测结果CV分别为9．90％和3．61％；检测系统可报告范围为0．30～5．77mmol／L；三个批号试条的批间差为5．1％；该法与酶动力学法结果之间具有良好的相关性（r=0．9926）；该系统测试健康人群末梢全血乳酸参考范围〈0．30mm01／L。结论 T-1型国产手持式血酮体分析仪进行全血酮体检测具有简便、快速、准确、重复性好等特点，与自动生化分析仪的酶法测定结果具有良好的相关性，各项性能指标均达到临床应用要求。Objective To evaluate the T-1 portable whole blood ketone body analyzer made by the technology of electronic chemistry in China for clinical use. Methods The accuracy,analysis precision and assay range were judged by using standard resistor stripe,standard beta-hydroxybutyric acid solution and fresh whole blood. Methodology comparison was done with enzyme method by using Beckman Coulter CX5 automated chemistry analyzer. Reference ranges were verified by testing 52 healthy individuals. Results The biases of four different levels of standard resistor stripe were all less than 5.0%, the recovery of four levels of whole blood standard solution were among 92.4-96.3%. In precision test,CV of the low and high level standard solution were 9.90% and 3.61%. The reportable range was 0.30-5.77 mmol/L. The variation of strips among three different lot numbers was 5.1%. The results of the portable analyzer showed good correlation with the enzyme method （r=0. 992 6） and reference range of capillary blood ketone bodies was below 0. 30 mmol/L. Conclusion The T-1 whole blood ketone body analyzer is a simple,stable and reliable device. It might be useful for clinical application and self-monitoring.

关 键 词：酮体 Β-羟丁酸 酮体分析仪 方法学评价 

分 类 号：R446.112[医药卫生—诊断学]