Evaluation of an Automated Dipstick Device for Urinalysis-UriDoctor

Kim, Namhee; Lee, Sun Min; Chang, Chulhun L

Abstract

BACKGROUND
We evaluated the recently marketed UriDoctor analyser (DFI Co., Ltd., Korea) for urinalysis and measurement of microalbumin and creatinine in urine.
METHODS
The precision within and betweenruns was evaluated using commercial control materials. The comparison evaluations were performed using patient urine samples. Urine dipstick tests for blood, bilirubin, urobilinogen, ketones, protein, nitrite, glucose, pH, specific gravity, and leukocyte esterase were performed with UriDoctor using CYBOW10 strips (DFI Co., Ltd., Korea) and with AX4030 using Aution Sticks 10EA (Arkray Inc., Japan), and the results were compared. Additionally, tests for microalbumin and creatinine were performed with UriDoctor using CYBOW2AC strips and with the Cobas c501 system (Roche Diagnostics, Germany), and the results were compared.
RESULTS
The within-run and between-run precisions for urinalysis using UriDoctor were both 100%. The concordance rates and concordance rates including +/-1 grade between UriDoctor and AX4030 were as follows: blood (90%, 100%); bilirubin (97%, 100%); urobilinogen (98%, 100%); ketones (92%, 100%); protein (83%, 100%); nitrite (100%, 100%); glucose (85.0%, 100%); pH (58%, 94%); specific gravity (32%, 80%); leukocyte esterase (89%, 93%). The concordance rates between UriDoctor and the Cobas c501 system were as follows: microalbumin (71%); creatinine (46%); albumin-creatinine ratio (65%).
CONCLUSIONS
UriDoctor showed good precision. There was significant agreement between the results of UriDoctor and AX4030, except for pH and specific gravity. The albumin-creatinine ratio showed relatively low specificity and high sensitivity; therefore, it would be more suitable for screening patients. The performance of UriDoctor when used with CYBOW10 and CYBOW2AC strips was satisfactory for clinical application.