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http://dx.doi.org/10.15324/kjcls.2021.53.1.19

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

Cha, Kyung Jae (Department of Field Application Scientist Team, Shinyang Chemical Co.,Ltd.)
Publication Information
Korean Journal of Clinical Laboratory Science / v.53, no.1, 2021 , pp. 19-31 More about this Journal
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.
Keywords
Fecal occult blood test; LX detergent cleaning solution; Precision;
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