What recent changes in IVDR requirements have been introduced for PCR instrumentation?
In vitro diagnostic regulation (IVDR) is built around workflow and data interpretation to help ensure the results of molecular diagnostic tests are robust and reliable. In the context of PCR instrumentation, IVD systems must undergo validation to ensure adherence to the hardware and software specifications laid out by the IVDR. For example, equipment manufacturers cannot simply run a bug fix that suddenly unlocks a particular application that would be otherwise protected in the clinical lab. Ultimately, these specifications aim to help provide data security and maintain patient privacy. PCR instruments like Applied Biosystems™ QuantStudio™ 7 Pro Dx and QuantStudio™ 5 Dx real-time PCR systems have been designed and updated to adhere to these IVDR requirements.
For molecular diagnostic labs, what PCR instrument features should they prioritize?
Data security is a necessity for clinical labs and is part of any system currently on the market. However, what comes up again and again is that clinical labs never have enough staff to carry the intensive workflow, from acquiring samples and performing an assay to analyzing and reporting results. Therefore, the most important aspect when choosing PCR instrumentation is efficiency, which can be achieved through a combination of automation and digitalization features to help streamline workflows and minimize laborious tasks that can further strain staff. In addition, ease-of-use helps labs adopt new technologies and assays, and the ability to conduct multiplex testing allows labs to answer several questions simultaneously.
How is PCR technology changing to support efficiency and reduce the carbon footprints of clinical labs?
Along with minimizing energy consumption to help reduce the carbon footprint of our newest QuantStudio PCR systems, the biggest change geared toward boosting efficiency has been designing a secure digital ecosystem for your lab, primarily through Applied Biosystems Diomni™ Software. Now, you can connect all of your instruments, like your liquid handlers and PCR systems, into one ecosystem on a single dashboard that can be shared among lab personnel. With remote monitoring, you can receive notifications and data anywhere you have secure access to the internet. Lastly, with laboratory information system (LIS) connectivity, we can help ensure the PCR system has an uptime of 98 percent.
Clinical labs already using Diomni software are reducing their interpretation time by 30–40 percent—a significant improvement in efficiency. Notably, Diomni software is backward compatible, so you do not need to buy new equipment (creating waste) to benefit from digitizing and streamlining your lab’s workflows.
Applied Biosystems™ QuantStudio™ Real-Time PCR Systems are for in vitro diagnostics use.