Evaluation of an Automated Dipstick Device for Urinalysis-UriDoctor.
10.15263/jlmqa.2014.36.4.190
- Author:
Namhee KIM
1
;
Sun Min LEE
;
Chulhun L CHANG
Author Information
1. Department of Laboratory Medicine, Pusan National University School of Medicine, Busan, Korea. yaong97@hanmail.net
- Publication Type:Original Article
- Keywords:
Urinalysis;
Urine;
Albuminuria;
Kidney diseases
- MeSH:
Albuminuria;
Bilirubin;
Creatinine;
Glucose;
Humans;
Hydrogen-Ion Concentration;
Ketones;
Kidney Diseases;
Leukocytes;
Mass Screening;
Sensitivity and Specificity;
Specific Gravity;
Urinalysis;
Urobilinogen
- From:Journal of Laboratory Medicine and Quality Assurance
2014;36(4):190-195
- CountryRepublic of Korea
- Language:Korean
-
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.
