QIAGEN announced the launch of the QIAcuityDx Digital PCR System. The instrument and accessories are 510(k) exempt in the U.S. and IVDR-certified for diagnostic use in Europe.
QIAcuityDx streamlines clinical testing by providing absolute quantitation of target DNA and RNA, supporting applications with less invasive liquid biopsies.
The QIAcuityDx platform is an IVD medical device that integrates partitioning, thermocycling, and imaging into a streamlined 5-plex workflow within a single instrument. Capable of processing up to four nanoplates simultaneously, it reduces lab space requirements, servicing needs, and operator time.
QIAcuityDx’s technology enables higher throughput, allows for imaging of partitions, improves precision and sensitivity, cuts processing times to just two hours, and reduces the risk of cross-contamination.
QIAcuityDx software is designed for diagnostic use, featuring a user-friendly interface and comprehensive audit trail compliant with modern lab requirements. It includes two modes:
- An IVD mode offering validated assay plug-ins and automated analysis.
- A Utility Mode, providing flexibility to laboratories for their laboratory-developed tests (LDTs) and research applications.
The QIAcuity-DX platform supports continuous sample loading and flexible scheduling, accommodating urgent testing needs without compromising patient results. To ensure diagnostic compliance and meet clinical customer needs, QIAcuityDx will include:
- A bi-directional LIMS (Laboratory Information Management System) interface for seamless integration with electronic patient records.
- QIAcuityDx-optimized universal master mix and nanoplates manufactured under strict regulatory standards.
- A validated installation process supporting lab compliance with an audit-ready report.
- 5-channel calibration enhancing image processing and reproducibility.
