Laboratory Evaluation of Automated Urine Analyzer ComboStick Reader 720(R) and Reagent Strip ComboStick 10 / 임상검사와정도관리

ABSTRACT

BACKGROUND: The ComboStick Reader 720(R)(DFI Co., Ltd. Korda) is a newly developed automated urine analyzer. The objective of this analysis was to evaluate the analytical performance of the Combostick Reader 720 and ComboStick 10 reagent strips and to compare the results using the Uriscan Pro II and Uriscan Gen 10 SGL strips (YD Diagnostics, Korea). METHODS: The Dipstick urinalyses were performed on a ComboStick Reader 720(R) using ComboStick 10 strips and on a Uriscan Pro II(R) using Uriscan 10 SGL strips. Precision was evaluated with commercial control materials. The sets of results were analyzed for concordance with weighted kappa values or intraclass correlation coefficients (ICCs). The microscopic urine analysis was carried out to confirm the results from both automated urine analyzers. Agreement between the dipstick methods and the microscopic method was evaluated by kappa values and the McNemar test. RESULTS: Within and between-run precisions of the ComboStick Reader 720(R) were 90.0% to 100%. A comparison of results from 1,700 urine samples using the ComboStick Reader 720(R) and Uriscan Pro II(R) revealed a very high concordance rate of > or = 91.0% on consideration of neighboring blocks for all analytes of the dipstick urinalysis. There was a good association between the microscopic method and the dipstick methods of the two automated urine analyzers. The ComboStick Reader 720(R) revealed a statistically higher degree of agreement for leukocytes. CONCLUSIONS: The ComboStick Reader 720(R) and ComboStick 10 strips showed good precisions and revealed a statistically significant agreement with the Uriscan Pro II(R) and Uriscan 10 SGL strips. For leukocytes, the ComboStick Reader 720(R) was superior to the Uriscan Pro II(R) in comparing the agreement between the microscopic and dipstick methods. The overall performance of the ComboStick Reader 720(R) and ComboStick 10 strips were satisfactory.