手持式全血乳酸分析仪的临床评价  

Evaluation of a Portable Whole Blood Lactate Analyzer

作　　者：夏良裕[1] 鄢盛恺[1] 宋耀虹[1] 李元光 葛增梅[1] 李君[1] 庞新 何伟 

机构地区：[1]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 [2]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》2006年第2期1-3,共3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H-1型国产手持式全血乳酸分析仪进行临床评价.方法采用标准电阻条、标准乳酸锂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%;高、中、低3个水平的乳酸回收率为88.5%～90.5%;精密度试验：低、高两个乳酸水平的变异系数分别为7.0%,5.4%;检测系统可报告范围为0.5～17.5 mmol/L;三个批号试条的批间差为6.6%;该法与传统的酶法之间结果具有良好的相关性（相关系数r=0.996 4）;该系统测试健康人群末梢全血乳酸参考范围为0.44～21.6 mmol、L.结论 H-1型国产手持式乳酸分析仪进行全血乳酸检测具有简便、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 a portable whole blood lactate analyzer made in China for clinical use. Methods The accuracy ,analysis precision and clinical reportable range were judged by using standard resistor strips, standard lithium lactate solution and fresh whole blood. Methodology comparison was done with DADE BEHRING DIMENSION RXL＇s enzyme method. Reference ranges were verified by testing 50 healthy individuals. Results The biases of five different levels of standard resistor strips were all less than 5. 0% ,the recovery of three levels of whole blood standard solution were among 88.5%-90. 5%. In precision test,CV of the low and high level standard solution were 7.0% and 5.4%. The reportable range was 0.5-17. 5 mmol/L. The variation of strips among three different lot numbers was 6.6%. The results of the portable analyzer showed good correlation with the enzyme method （r=0. 996 4） and reference range was 0. 44-2. 16 mmol/L. Conclusion H-1 whole blood lactate analyzer is a simple ,stable and reliable device ,it might be useful for clinical application.

关 键 词：乳酸 手持式乳酸分析仪 方法学评价 

分 类 号：R446.112[医药卫生—诊断学]