尿有形成分质控品的研制和观察

Development and observation of quality control material of urinary formed elements

目的制备一种重复性好、稳定期长的尿有形成分质控品，有助于日常检验工作中对尿中有形成分进行质量控制。方法按美国临床实验室标准化协会（CLSI）GP16-A3文件要求收集不同肾病患者的尿液，固定后分装保存。使用具备流式细胞术、显微摄影法和染色技术原理的设备，观察红细胞（RBC）、白细胞（WBC）、上皮细胞、管型和细菌存在与否和形态保持情况；按CLSIEP25文件要求观察各类有形成分的稳定性；同时配制高、中、低3种不同浓度质控品进行精密度检测。结果有形成分质控品中所含RBC、WBC、上皮细胞、管型和细菌等有形成分的形态保持良好，易于辨认。重复性较好，RBC变异系数（CV）为4．4％-7．8％，WBC为4．3％～14．3％，上皮细胞为4．8％～14．4％，管型为16．9％～23．3％；稳定期可达130d。结论制备的尿有形成分质控品含有RBC、WBC、上皮细胞、管型和细菌等有形成分，且有较好的重复性和稳定性，适用于临床尿有形成分质控之用途。

Objective To prepare a quality control material of urinary formed elements with good repeatability and stability, and improve the quality control of urinary formed elements in the routine urine test. Methods According to Clinical and Laboratory Standards Institute （CLSI） GP16-A3 ,a variety of urine samples from the kidney disease patients was collected, stabilized and stored. By means of flow cytometry, microscopy and staining technique, the existence and storage state of red blood cells （RBC） ,whir blood cells （WBC）, epithelial cell, casts and bacteria were observed in terms of CLSI EF25 requirement. Meanwhile, the control materials with high, medium and low concentrations were prepared to measure precision. Results The quality control material of urinary formed elements presented good holdings and easily identified feature of RBC, WBC, epithelial cell, casts and bacteria. The results of coefficient of variation （CV） were as follows：RBC 4.4% -7.8% ,WBC 4.3% -14.3% ,epithelial cell 4.8% -14.4% and casts 16.9% -23.3%. The quality control was stable state up to 130 d. Conclusions The prepared quality control material of urinary formed elements contains RBC,WBC,epithelial cell,casts and bacteria. It shows relatively good repeatability and stability,and can be used for quality control of urine test in clinical laboratory.