天津市临床实验室尿白蛋白检测调研及改进计划

Investigation and improvement of urine albumin measurement in clinical laboratories in Tianjin

目的：调查分析天津市临床实验室尿白蛋白检测现状。方法用患者新鲜尿液制备质控物在2～3级医院临床实验室开展尿白蛋白室内质量控制；ERM－DA470K蛋白标准物质样本进行第一次调查并计算各实验室偏倚，对偏倚不合格实验室进行实验室仪器的维护、项目校准、规范操作以及室内质控等改进；开展第二次尿白蛋白室间质量评价并计算各实验室间的变异及偏倚。结果（1）参加调研的52家实验室共有12个系列检测仪器，17种国内外不同试剂。31家实验室上报数据精密度调研显示93．55％实验室精密度良好，但室间变异较大，低值质控检测范围8．91～43．95 mg／L，变异系数为34．46％；高值质控检测范围36．32～281．0 mg／L，变异系数为28．51％。（2）第一次尿白蛋白室间质评正确度验证试验仅有36．5％实验室合格；散射比浊法和透射比浊法合格率较高（55．6％，42．9％）。第二次室间质评的两个标准样本和三个新鲜尿样本标本室间变异分别为19．83％、11．37％、13．57％、13．41％、13．08％，正确度验证合格率58．06％，散射比浊法和透射比浊法合格率为71．4％和56．3％。结论天津市各临床实验室尿白蛋白检测仪器、系统繁杂且存在较大差异，加强实验室规范性操作及改善个别实验方法的校准品可以提高检测一致性。（中华检验医学杂志，2015，38：353－356）

Objective To investigate the situation of urine albumin measurement of clinical laboratory in Tianjin.Methods Control materials from patient mixed urine samples were made to validate precision in the clinical laboratories in Tianjin.Reference Material ERM-DA470K was prepared as the first external quality assessment （ EQA） sample, and the bias between laboratories was calculated.Then we give some advice about the methods of routine maintenance, calibration, standardized operation, internal quality assessment and so on to the laboratories which were not qualified in the first EQA.Then the second EQA was carried out and CV and bias were culculated.Results 52 clinical laboratories has 12 series of instruments and 17 series of reagents.The precision research showed that most laboratories （ 93.55%） had good precision for urine albumin measurement, while CV of inter-laboratory was great：the range of low level of control sample was 8.91 -43.95 mg/L, 34.46% for CV; and the high level was 36.32 -281 mg/L, 28.51% for CV.Only 36.5% laboratories were qualified in the first EQA. The qualified rate for nephelometry and turbidimetry was higher （55.6%, 42.9%）.The qualified rate of trueness verification was 58.6%in the second EQA, and the CV between laboratories was significantly decreased, Inter-laboratory CV of the five samples were：19.83%, 13.57%, 13.41%, 13.08%, 11.37%. The qudified rate for nephelomety and turbidimetry was 71.4% and 56.3%.Conclusions There are a mide variety of measurement systems of urine albumin in Tianjin, and the CV between these systems is great.Clinical laboratory should strengthen the laboratory standardization operation and upgrade calibration testing to improve the testing consistency.