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

• Main Author: Kyung Jae Cha
• Format: Article
• Language: English
• Published: The Korean Society for Clinical Laboratory Science 2021-03-01
• Series: Korean Journal of Clinical Laboratory Science
• Subjects: fecal occult blood test; lx detergent cleaning solution; precision

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.