PathoSEEK® qPCR assays are compatible with the CFX Opus because the CFX Opus and CFX96 Touch Real-Time PCR Systems are comparable.
CFX96 Touch and CFX Opus Real-Time PCR System Compatibility Study
In the pharmaceutical and biotechnology sectors, conducting a comparability study is essential whenever adjustments are made to established protocols or equipment. This type of study, often referred to as a bridging study, aims to furnish analytical evidence that such changes will not negatively impact the integrity of the previously approved processes.
In the study performed by the manufacturer, Bio-Rad presents two model bridging studies that demonstrate the comparability of the new CFX Opus 96 and CFX Opus 384 Real-Time PCR Systems to the CFX96 and CFX384 Touch Real-Time PCR Systems. Bio-Rad evaluates their performance across several critical parameters, including specificity, linearity, range, accuracy, precision, limit of detection (LOD), limit of quantification (LOQ), robustness, and overall system suitability.
A Model qPCR System Comparability Study: CFX Touch and CFX Opus Real-Time PCR Platforms