CAJ | 학술논문

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。
목적：평고HC-900전자동뇨액간화학분석의급배투시지조（HC-900분석계통）검측뇨액미량청단백（U-mAlb）적림상응용개치。방법이HC-900분석계통검측뇨단백음성위표준수집660빈뇨양，대기중시지조사사U-mAlb위양성159빈화부분음성106빈적표본채용Immage 800전자동특정단백분석의（Immage 800의）진행정량분석，이험증HC-900분석계통적사사효과。사사양성조화음성조간U-mAlb정량검측결과비교채용량양본비교적질화검험。계수자료비교채용일치성Kappa검험。결과159빈U-mAlb양성표본경Immage 800의정량검측，학정기중101빈위U-mAlb양성，진양성솔위63．5％。수궤추취적106빈경HC-900분석계통사사U-mAlb음성표본，사용Immage 800의정량검측，학정기중9빈위 U-mAlb양성。경일치성검험，량충방법차이유통계학의의（Kappa＝0．495，P＜0．01）。사사양성조U-mAlb수평위18．02（8．23～34．89）mg/L ，현저고우음성조적4．78（2．51～8．46） mg/L ，차이유통계학의의（Z＝-8．689，P＜0．01）。상대우Immage 800의정량검측，간화학법쾌속사사U-m A lb적민감도위91．8％（101/110），특이도위62．5％（97/155）。결론 H C-900분석계통사사뇨액U-m A lb방편쾌첩，유일정림상응용개치。
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<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<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 .