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OC Sensor PLEDIA를 이용한 LX Detergent Cleaning Solution과 OC Detergent Cleaning Solution의 동등성 평가

Analysis of a Comparability Test between LX Detergent Cleaning Solution and OC Detergent Cleaning Solution Using OC Sensor PLEDIA

대한임상검사과학회지 2021년 53권 1호 p.19 ~ 31
차경재,
소속 상세정보
차경재 ( Cha Kyung-Jae ) - Shinyang Chemical Co.,Ltd. Department of Field Application Scientist Team

Abstract


This study aimed at comparing the performance of imported LX detergent cleaning solution (LX-CS) and the self-manufactured OC cleaning solution (OC-CS), based on functional and quantitative analysis. The functional analysis was carried out using apparent diffusion coefficient (ADC) values.
For quantitative analysis, precision, linearity, and carry-over rates were measured with commercial control materials according to the Clinical and Laboratory Standards Institute (CLSI) guidelines. Using OC-Sensor PLEDIA (Eiken Chemical, Japan), the ADC value of all cuvettes satisfied the acceptance criteria. For quantitative analysis, precision was less than 5.0% for the two products, and carry-over rates were less than ±1.00%. The linearity slopes and r2 values were 1.0017 and 0.9982 in the LX-CS, and 0.9924 and 0.9996 in the OC-CS, respectively. The correlation coefficient (r) was found to be 0.9997. Also, the percent difference in correlation with 40 artificial-stool specimens was less than 10% and the p-value was less than 0.1. The result of standard deviation ratio (D: ±1 SD ratio) was similar for both products. In conclusion, the functional and quantitative analyses of the two products were compared and showed similar results. In the future, the self-manufactured OC-CS will be able to provide a much more stable and faster supply than the imported LX-CS.

키워드

Fecal occult blood test; LX detergent cleaning solution; Precision

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