The Quality Assessment of Artificial Urine and Urine Sediment Slide for Chemical and Microscopic Examinations in Urinalysis

Abstract

Quality control of urinalysis consists of chemical and microscopic examinations. External quality assessment (EQA) programs in Thailand employs a variety of different methods. The aim of this study was to develop and evaluate the artificial urine control materials for chemical examination, including pH, specific gravity, blood, ketone, glucose, protein, nitrite and leukocyte esterase, and the urine sediment slide for microscopic examination, including white blood cells, white blood cells with clumping, red blood cells, squamous epithelial cells, calcium oxalate crystal and bacteria. Two levels of artificial urine samples, normal and abnormal samples, and urine sediment slides were prepared. Artificial urine samples were tested by automated urine analyzer from 3 companies to set the target value and tested by the urine strips from 6 companies. In addition, artificial urine samples were evaluated for homogeneity and stability for 6 months. Moreover, the performance and stability of urine sediment slides were also evaluated for 6 months. The artificial urine samples and urine sediment slides were evaluated by 62 medical technology laboratories. The results from the automated analyzers for all parameters revealed consistency. The results from urine strips were also found to be mostly consistent. When testing for homogeneity and stability, all test results were stable. The urine sediment slides were correctly identified after 6 months of storage. Evaluation from medical technology laboratories showed that the results of normal and abnormal artificial urine samples were reported within target value, more than 98.4% and more than 92%, respectively, except for ketone and leukocyte esterase. In addition, identifying of urine sediment slides was found to be 98.4% correct. In conclusion, the evaluation of the quality of urinalysis using artificial urine samples and urine sediment slides demonstrate that they are appropriate to be used as a quality control material