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pISSN 2950-9114 eISSN 2950-9122
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Original Article

J Lab Med Qual Assur 2014; 36(4): 190-195

Published online December 31, 2014

https://doi.org/10.15263/jlmqa.2014.36.4.190

Copyright © Korean Association of External Quality Assessment Service.

Evaluation of an Automated Dipstick Device for Urinalysis-UriDoctor

Namhee Kim, Sun Min Lee, and Chulhun L. Chang

Department of Laboratory Medicine, Pusan National University School of Medicine, Busan; Department of Laboratory Medicine and Molecular Genetics, Pusan National University Yangsan Hospital, Yangsan, Korea

Correspondence to:Sun Min Lee
Department of Laboratory Medicine and Molecular Genetics, Pusan National University Yangsan Hospital, 20 Geumo-ro, Mulgeum-eup, Yangsan 626-770, Korea
Tel: +82-55-360-1875
Fax: +82-55-360-1880
E-mail: yaong97@hanmail.net

Received: August 5, 2014; Revised: October 10, 2014; Accepted: October 21, 2014

This is an Open Access article distributed under the terms of the Creative Commons Attribution Non-Commercial License (http://creativecommons.org/licenses/by-nc/3.0) which permits unrestricted non-commercial use, distribution, and reproduction in any medium, provided the original work is properly cited.

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 albumincreatinine 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. (J Lab Med Qual Assur 2014;36:190-195)

Keywords: Urinalysis, Urine, Albuminuria, Kidney diseases

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