J Clin Pathol Qual Control.  1998 Jun;20(1):263-271.

Evaluation of Urine Analyzer URISCAN S300 and Reagent Strip URISCAN Gen 10SGL

• Chung HR
• Sohn HE

Abstract

BACKGROUND: Semiautomated urine analyzer URISCAN S300 URISCAN Gen 10SGL reagent strip were developed by Yeongdong pharmaceutical corporation in Korea. The performance of domestic urine reagent strip was evaluated comparing with the approved foreign reagent strip.
METHODS
We evaluated URISCAN Gen 10SGL reagent strip for precision, accuracy and correlation with Clinitek 200 (Ames Instrument Service, Miles Inc., USA) and N-Multistix(R) SG-L reagent strip (Bayer-Sankyo Co,, Ltd, Tokyo, Japan). Within-run precision was determined from those results from 1 normal and 4 abnormal urine specimens. Between-run and day-to-day precisions, and accuracy were analyzed by use of a commercial control materials, Uritrol I, II, III (Lot No. 9801, Yeongdong pharmaceutical corporation in Korea). The correlation study was done on 59 urine specimens. We also evaluated URISCAN Gen 10SGL reagent strip for detection of red blood cells (RBCs) and leukocytes (WBCs) in urine specimens.
RESULTS
Within-run precision of URISCAN Gen 10SGL were 80 to 100%. Between-run precision were 60 to 100%. Day-to-day precision were 57 to 100%. The accuracy were 100%. In correlation study, exact concordant rates of specific gravity and pH reactions were 37 and 36 % respectively. The exact concordant rates of the others 2343 78 to 98 %. URISCAN Gen 10SGL had sensitivity of 93.3 %, specificity of 92.9 % and efficiency of 93.0 % in detecting RBCs. The sensitivity, specificity and efficiency of URISCAN Gen 10SGL strip to detect WBCs were 72.7, 97.8 and 93.0 % respectively.
CONCLUSIONS
The performance of urine analyzer URISCAN S300 using URISCAN Gen 10SGL reagent strip was satisfactory for clinical application. URISCAN Gen 10SGL reagent strip test can be used to screen for routine urine microscopic examination.

MeSH Terms

Erythrocytes
Hydrogen-Ion Concentration
Korea
Leukocytes
Reagent Strips*
Sensitivity and Specificity
Specific Gravity
Statistics as Topic
Reagent Strips