The Performance Evaluation of Yeongdong URiSCAN GEN 10SGL Urine Dipstick Strip Using Other Quantitative, Microscopic, and Culture Methods / 대한임상병리학회지

ABSTRACT

BACKGROUND: The previous performance tests of URiSCAN GEN 10SGL dipstick reagent strip (Yeongdong pharmaceutical Co., Seoul, Korea) were mainly done by comparison with the approved urine strips. However, adequate comparison was inavailable because the grading systems were different among the manufacturers. We evaluated the correlation of new generation URiSCAN GEN 10SGL urine strip with known quantitative, microscopic, and culture methods. METHODS: We used urine specimens which were collected for the urinalysis and culture from November 2000 to Mars 2001. We evaluated the correlation between the results of URiSCAN GEN 10SGL and the quantitative methods by comparing the mean of change of reflectance rate (change %R) with the result of the corresponding quantitative method for protein, glucose, bilirubin, urobilinogen, pH, and specific gravity. To calculate the sensitivity and specificity, we used microscopic examination for leukocytes and erythrocytes, and used urine culture for nitrite test. RESULTS: The correlation coefficients between the change %R of URiSCAN GEN 10SGL and the corresponding quantitative method exceeded 0.81, except bilirubin and specific gravity (P<0.01; respectively). The agreements of identical or neighboring concentration block were more than 90%, except urobilinogen and specific gravy. The sensitivity and specificity of URiSCAN GEN 10SGL were 63.6% and 94.2% for leukocytes; 92.8% and 74.1% for erythrocytes; 74.4% and 85.0% for nitrite producing organisms. CONCLUSTIONS URiSCAN GEN 10SGL had acceptable accuracy and agreement compared with the corresponding quantitative methods and culture result. Also, it had improved sensitivity and specificity of leukocytes and erythrocytes detection compared with previous URiSCAN urine dipstick strip.