Whether you are part of a small academic lab or a multinational corporation, upgrading to a new quantitative PCR (qPCR) system can be both exciting and daunting. How will the new system perform compared to your current platform? Will your existing workflows translate smoothly? For users considering upgrading to the new CFX Opus Real-Time PCR System, we present direct performance comparisons in the form of a bridging study.
When looking at new instruments for an existing process, evaluating performance — not just technical specifications — is paramount. Bio-Rad customers range from small institutions and startups all the way to multinational biopharma companies, all of whom have expanded the use of genomics products from relative gene expression to process control, detection, and diagnostic workflows.
While it has been common for years for large diagnostics enterprises to perform clinically significant process validation, we are seeing more and more customers from other sectors who want to utilize these approaches when making any changes to their workflows. To respond to these needs, we recently released A Model qPCR Instrument Comparability Study: CFX96 Touch and CFX Opus 96 Real-Time PCR Systems — a bridging study for CFX96 Touch Real-Time PCR System users considering upgrading to the CFX Opus System.
Scientists and quality engineers in mature, regulated laboratories will already have bridging approaches for their instruments and processes, but this study should provide confidence that the new CFX Opus Systems will perform well across diagnostic dimensions when evaluated for diverse applications, specifically those already being done on the CFX96 Touch Systems.
Customers in smaller companies or in non-diagnostic segments often ask how we can assist with various levels of process validation when they are evaluating new instruments. We offer the bridging study as a model for evaluation and as a list of references for the evolving quality systems of these customers.
The bridging study references the United States Pharmacopeia (USP) and International Conference on Harmonization (ICH) guidance to propose metrics, experimental design, and analytical methods. We also specifically note metrics that were developed for diagnostics but should be considered for any detection workflow. Such workflows may involve detection of nucleic acid sequences for bioproduction (such as residual host DNA monitoring), assessment of animal health, infectious disease surveillance, or environmental monitoring.
In our study, we utilized a Zika, Dengue, and Chikungunya (ZDC) Real-Time PCR Assay to show a model system for human infectious diseases but the study framework should be adapted to utilize tests as close to the current process as possible.
We invite you to review our CFX Opus Real-Time PCR System comparison study and to reach out to your local Field Applications Specialist or Technical Support Scientist with any requests or questions about how our genomics portfolio can assist your work.