Comparability Study of CFX96 and CFX Opus Deepwell Dx Systems

This document is a technical report detailing a comparability study conducted to evaluate the analytical equivalence of the CFX96 Deep Well Dx System and the newer CFX Opus Deepwell Dx System. The study adheres to guidelines set forth by the United States Pharmacopeia Convention and the U.S. Food and Drug Administration. It outlines the experimental design, which includes the use of the Bio-Rad Reliance SARS-CoV-2 RT-PCR Assay Kit and the assessment of key performance characteristics such as specificity, linearity, accuracy, precision, limit of detection, and robustness. The study aims to provide diagnostic users with evidence that transitioning from the CFX96 Deep Well Dx System to the CFX Opus Deepwell Dx System will not adversely affect their processes. The report includes detailed descriptions of the methodologies employed, including the use of different software packages for data analysis and the acceptance criteria established for the experiments. The findings support the operational equivalency of both systems in a diagnostic context.