尿液微量白蛋白快速筛查方法应用的评估

The application evaluation of a rapid urine microalbumin screening test

目的评估一种尿液微量白蛋白（mALB）快速筛查方法的临床应用价值。方法选取2006年12月到2007年2月首都医科大学附属复兴医院尿常规检测标本613份，采用H-800全自动尿液分析仪干化学快速筛查法对mALB进行定性检测。对筛查阳性的标本和部分阴性标本采用Immage-800全自动特定蛋白分析仪同时做mALB的定量检测，以验证mALB的干化学法筛查效果。筛查阳性组与阴性组间mALB定量检测结果的比较采用两样本比较的秩和检验。计数资料的比较采用一致性Kappa检验。结果613份尿常规检测标本中，经干化学快速筛查法检测为mALB阳性的共114份，阳性率为18．6％。114份阳性标本中，经Immage-800全自动特定蛋白分析仪定量检测确定为mALB阳性的共71份（mALB检测结果〉13．3mg／L为阳性）。76份经干化学快速筛查法检测为mALB阴性的标本，经定量检测确定为mALB阳性的有8份。经一致性检验，干化学法与定量检测法差异有统计学意义（Kappa=0．481，P〈0．01）。筛查阳性组mALB水平为17．70（9．19—32．90）mg／L，显著高于阴性组的4．55（2．38—7．60）mg／L，差异有统计学意义（Z=-8．644，P〈0．01）。相对于定量法，该mALB快速筛查方法的检测敏感度为89．9％（71／79），特异度为61．3％（68／111）。结论mALB快速筛查法具有一定的筛查价值，但存在一定的漏诊率，应进一步完善检测方法，提高检测敏感度。

Objective To evaluate the clinical application value of a kind of rapid urine microalbumin（ mALB ） screening test. Methods Six hundred and thirteen samples for urine routine detection from Affiliated Fuxing hospital, Capital Medical University were included from December 2006 to February 2007. mALB of all urine samples was detected with H-800 automated urine analyzer based on a dry chemical qualitative screening test. To validate the screening effect of the dry chemical screening test, all of the positive samples and a part of negative samples were determined by a mALB quantitative test as confirmation by Immage-800 automated specific protein analyzer. Comparison of mALB quantitative level between screening positive group and negative group was carried out by 2 independent samples rank sum test. Comparison between enumeration data was carried out by Kappa test for consistency. Results One hundred and fourteen positive samples out of 613 were detected by screening method （ 18.6% ）. Out of the 114 positive samples by screening test, seventy-one samples were confirmed positive by quantitative test （mALB 〉 13.3 rag/L）. Out of 76 negative sample by screening test, eight samples were confirmed positive by quantitative test. The mALB level of the screening positive group and negative group was 17.70 （ 9. 19 - 32. 90） mg/L and 4. 55 （2. 38 -7.60） rag/L, respectively, and the mALB level of the screening positive group was much higher than that of the negative group （Z = - 8. 644, P 〈 0. 01 ） . According to the quantitative test, the sensitivity and specificity of the mALB screening method were 89. 9% （71/79） and 61.3% （68/111 ）, respectively. Conclusions The mALB rapid screening test in the research has a certain screening value. But the test method should be further perfected to improve its sensitivity for its certain omission rate. （ Chin J Lab Med ,2012,35：647-649）