HC-900尿液分析仪快速筛查尿液微量清蛋白的应用评估  

Application evaluation of HC-900 urine analyzer for rapidly screening urine microalbumin

作　　者：马文 巫炀[2] 张善辉[2] 王平平[2] 

机构地区：[1]姜堰市血站,江苏姜堰225500 [2]姜堰市人民医院检验科,江苏姜堰225500

出　　处：《国际检验医学杂志》2014年第5期603-604,606,共3页International Journal of Laboratory Medicine

摘　　要：目的：评估HC-900全自动尿液干化学分析仪及配套试纸条（HC-900分析系统）检测尿液微量清蛋白（U-mAlb）的临床应用价值。方法以HC-900分析系统检测尿蛋白阴性为标准收集660份尿样，对其中试纸条筛查U-mAlb为阳性159份和部分阴性106份的标本采用Immage 800全自动特定蛋白分析仪（Immage 800仪）进行定量分析，以验证HC-900分析系统的筛查效果。筛查阳性组和阴性组间U-mAlb定量检测结果比较采用两样本比较的秩和检验。计数资料比较采用一致性Kappa检验。结果159份U-mAlb阳性标本经Immage 800仪定量检测，确定其中101份为U-mAlb阳性，真阳性率为63．5％。随机抽取的106份经HC-900分析系统筛查U-mAlb阴性标本，使用Immage 800仪定量检测，确定其中9份为 U-mAlb阳性。经一致性检验，两种方法差异有统计学意义（Kappa＝0．495，P＜0．01）。筛查阳性组U-mAlb水平为18．02（8．23～34．89）mg/L ，显著高于阴性组的4．78（2．51～8．46） mg/L ，差异有统计学意义（Z＝-8．689，P＜0．01）。相对于Immage 800仪定量检测，干化学法快速筛查U-m A lb的敏感度为91．8％（101/110），特异度为62．5％（97/155）。结论 H C-900分析系统筛查尿液U-m A lb方便快捷，有一定临床应用价值。Objective To evaluate the clinical application value of the HC-900 fully automated urine dry chemistry analyzer and its matched test strip （HC-900 analysis system） for detecting urine microalbumin （U-mAlb） .Methods 660 urine samples were collected with the negative urine protein detected by the HC-900 analysis system as the standard ,among them ,159 samples with positive U-mAlb screened by the test strip and 106 samples with the partial negative were performed the quantitative analysis by the Immage 800 fully automatic specific protein analyzer for verifying the results screened by the HC-900 analysis system .The compari-son of the U-mAlb quantitative detection results between the screening positive group and the screening negative group adopted the two samples rank sum test .The comparison between the enumeration data was carried out by Kappa test for consistency .Results Among 660 samples ,159 samples with positive U-mAlb were quantitatively detected by the Immage 800 analyzer and 101 samples were confirmed positive U-mAlb with the real positive rate of 63 .5% .Among 106 samples of negative U-mAlb randomly extracted by the HC-900 analysis system ,9 samples were confirmed to be positive U-mAlb quantitatively detected by the Immage 800 analy-zer .By the consistency test ,the difference between the two methods had statistical significance （Kappa=0 .495 ,P＆lt;0 .01） .The U-mAlb level was 18 .02（8 .23-34 .89）mg/L in the screening positive group ,which was significantly higher than 4 .78（2 .51-8 .46） mg/L in the screening negative group ,the difference had statistical significance （Z= -8 .689 ,P＆lt;0 .01） .Relative to the detection by the Immage 800 quantitative analyzer ,the sensitivity and specificity of the U-mAlb for the rapid screening by the dry chemistry method was 91 .8% （101/110） and 62 .5% （97/155） respectively .Conclusion The HC-900 analysis system for screening U-mAlb has a certain clinical application value .

关 键 词：尿液微量清蛋白 干化学 尿分析 

分 类 号：R446.12[医药卫生—诊断学]