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全自动尿沉渣分析仪的临床应用评价

Clinical Application of A Fully-automatic Urine Sediment Analyzer

    摘要
  • 摘要:
      目的  对一种全自动尿沉渣分析仪的临床应用进行评价, 并建立其对尿液有形成分分析的正常参考范围。
      方法  从仪器精密度、携带污染率、分析测量范围以及与人工镜检的可比性4个方面进行评价, 同时建立仪器检测红细胞(red blood cell, RBC)、白细胞(white blood cell, WBC)、鳞状上皮细胞(squamous epithelial cell, EC)及管型的正常参考范围。
      结果  RBC低值、中值和高值精密度的变异系数分别为129.10%、20.59%和7.80%;WBC低值、中值和高值精密度的变异系数分别为65.73%、14.30%和13.00%;EC中值和高值精密度的变异系数分别为27.01%和21.46%。RBC、WBC和EC的携带污染率均为0;RBC分析测量范围为0~83 608个/μl, WBC分析测量范围为0~15 624个/μl, 细菌分析测量范围根据菌种不同而结果有明显差异。仪器与人工镜检相比, RBC、WBC和EC的一致率分别为82.80%、73.82%和57.56%。男性尿液有形成分的参考范围显示, RBC为0~8个/μl, WBC为0~12个/μl, EC为0~13个/μl, 管型为0~4个/μl, 结晶为0~34个/μl; 女性尿液有形成分的参考范围显示, RBC为0~12个/μl, WBC为0~21个/μl, EC为0~42个/μl, 管型为0~4个/μl, 结晶为0~2个/μl。
      结论  该全自动尿沉渣分析仪对尿中的RBC和WBC有较好的识别性能, 对结晶、管型、真菌、异形细胞等难以自动识别的成分, 可利用仪器的审核功能进行人工识别, 必要时进行人工复检, 为临床提供可靠的检验报告。

     

    Abstract:
      Objective  To evaluate the clinical application of a fully-automatic urine sediment analyzer and establish the reference range of urinary formed elements.
      Methods  The precision, carryover rate, analytical measurement range, and comparability with manual microscopy method were evaluated, and the reference ranges of red blood cells (RBC), white blood cells (WBC), squamous epithelial cells (EC), and casts by the instrument were analyzed.
      Results  The low, medium, and high values of precision were 129.10%, 20.59%, and 7.80% for RBC, and 65.73%, 14.30%, and 13.00% for WBC. The medium and high values of precision for EC were 27.01% and 21.46%. The carryover rate of RBC, WBC, and EC were all 0. The measurement range was 0-83 608/μl for RBC and 0-15 624/μl for WBC. As to the measurement range of bacteria, there were obvious differences according to the different species of bacteria. When compared the instrument results with the manual microscopy, the consistency rates were 82.80% for RBC, 73.82% for WBC, and 57.56% for EC. The reference ranges of urinary formed elements were as follows: the range of urinary RBC was 0-8/μl for males and 0-12/μl for females; the range of urinary WBC was 0-12/μl for males and 0-21/μl for females; the range of urinary EC was 0-13/μl for males and 0-42/μl for females; the range of urinary cast was 0-4/μl for males and 0-4/μl for females; and the range of urinary crystal was 0-34/μl for males and 0-2/μl for females.
      Conclusions  This fully-atomatic urine sediment analyzer has better recognition performance for RBC and WBC. We can carry on the manual recognition using audit function by instruments, and manual morphological examination when necessary, to detect crystals, casts, fungi, and irregular cell components which are difficult to identify automatically.

     

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