Applied Biosystems™ SeqStudio™ 8 Flex Dx Genetic Analyzers

Descripción

The Applied Biosystems SeqStudio™ 8 Flex Dx Genetic Analyzer and the SeqStudio™ 24 Flex Dx Genetic Analyzer are advanced, IVDR-compliant, capillary electrophoresis (CE) DNA analysis systems designed to meet the evolving needs of clinical laboratories. Building upon the trusted technology of the Applied Biosystems 3500 Dx Genetic Analyzer, this innovative platform offers enhanced functionalities with multi-functional modes; In Vitro Diagnostic Use (IVD), Investigational Use Only and For Use in Performance Evaluation Studies ('IUO'), and Research Use Only (RUO) modes.

The system enables laboratory information management system (LIMS) compatibility, improved data quality, and an intuitive design with time-saving features. Key advantages include high accuracy with proven technology, a simplified workflow for time-to-results, and cost-effectiveness. The SeqStudio™ Flex Dx Series Genetic analyzers combine highly accurate resolution, reliable results, and scalability to accommodate varying laboratory sample intakes, making it an ideal solution for clinical laboratories seeking regulatory compliance and increased efficiency.

SeqStudio™ Flex Dx Series Genetic Analyzer features include:

• SAE module - integrated with the Security, Auditing, and E-Signature (SAE) Dx module enables 21 CFR Part 11 compliance and data integrity
• Versatile operational modes (IVD, RUO, and IUO) with an open system architecture, supporting the full spectrum of assay development, verification, and clinical testing workflows
• 8-capillary and 24-capillary configurations, both featuring a 4-plate capacity
• Advanced scheduling capabilities, including continuous plate loading and dynamic sample reprioritization, optimizing laboratory efficiency and workflow flexibility
• Remote troubleshooting functionality for expedited issue resolution, helping to reduce downtime and enhancing system reliability
• User-friendly interface with an interactive touchscreen, coupled with automatic spectral calibration capabilities, streamlining operation and maintenance procedures
• LIMS integration-ready, facilitating easy data management and enhancing laboratory informatics infrastructure

Advanced IVD workflow integration

The SeqStudio™ Flex Dx Series Genetic Analyzer offers an IVDR-compliant system with validated IVD on-instrument consumables. This integration enables a simple IVD workflow, crucial for modern diagnostic laboratories. The system's versatility is evident in its multiple operational modes—RUO, IUO, and IVD—allowing for smooth transitions from development, validation, investigational use, to diagnostic testing. Furthermore, the analyzer is fully integrated with the SAE Dx module, enhancing its utility in clinical settings.

Flexible assay development and customization

The open system architecture of the SeqStudio™ Flex Dx Series Genetic Analyzer facilitates straightforward IVD assay development. Users can create injection protocols using either factory-provided or custom library options, with the ability to publish validated injection protocols from RUO mode for use in IVD mode upon approval from regulatory authority. This flexibility extends to the creation and utilization of custom dye sets, offering researchers and clinicians unprecedented adaptability in their assay designs.

User-friendly Interface and operation

Ease of use is a hallmark of the SeqStudio™ Flex Dx Series Genetic Analyzer. The system boasts several user-friendly features, including easy capillary array installation, streamlined one-button startup, and auto-spectral calibration capabilities. An onboard learning center further enhances usability and simplifies training, making the analyzer suitable for both single-user and multi-user environments. These features collectively contribute to exceptional usability and efficient operation.

Sample prioritization with flexible scheduling

The SeqStudio™ Flex Dx Series Genetic Analyzer offers remarkable sample loading flexibility, featuring a four-plate capacity and continuous plate loading. The system also allows for urgent sample reprioritization, providing both mid-throughput capacity and scheduling flexibility. Available in both 8- and 24-capillary configurations, the analyzer is specifically designed to meet the diverse needs of clinical laboratories.

Remote access and data management

Through integration with the Thermo Fisher Connect cloud-based platform, the SeqStudio™ Flex Dx Series Genetic Analyzer offers enhanced flexibility and simplified collaboration. Users can remotely set up plates, monitor runs, and transfer data, allowing them to stay connected to their instrument and data from virtually anywhere. This remote capability helps improve laboratory workflow and productivity.

Advanced troubleshooting and support

The SeqStudio™ Flex Dx Series Genetic Analyzer SeqStudio™ Flex Dx Series Genetic Analyzer incorporates remote troubleshooting capabilities. Up to 70% of issues can be resolved remotely, drastically reducing downtime. The system includes Smart Help functionality, offering push-button access to technical support, on-screen technical assistance, and the ability to share log and run files. Additionally, the Remote Support feature allows for secure real-time collaboration with service engineers, effectively bringing expert assistance directly to the laboratory.

Advanced communication and connectivity

The analyzer is equipped with advanced communication and connectivity features, including LIMS integration capabilities. It incorporates modern communication technologies such as voice commands and a wide array of connectivity options, positioning laboratories for future efficiencies. The system runs on Microsoft Windows software, supporting up-to-date cybersecurity protection.

Versatile applications for expanding laboratory capabilities

The SeqStudio™ Flex Dx Series Genetic Analyzer supports fragment analysis and Sanger sequencing. These capabilities enable laboratories to expand their testing menus and grow their offerings based on regulatory approval in critical areas such as inherited diseases, oncology, and drug resistance testing, among others. This versatility makes the analyzer an invaluable tool for trained users in the field of capillary electrophoresis.

Comprehensive service and support

Thermo Fisher Scientific provides extensive services and support to maintain optimal performance of the SeqStudio™ Flex Dx Series Genetic Analyzer. The instrument comes with a standard 1-year factory warranty, customer concierge services, and SmartStart orientation. Additionally, an advanced digital service ecosystem is built directly into the instrument, allowing readily available support and maintenance resources.