Rotor-Gene AssayManager

Rotor-Gene AssayManager is able to read in sample information, set up experiments, control up to 4 different Rotor-Gene Q cyclers, acquire data from these instruments, automatically analyze results, and create reports. All information on how to run, analyze, interpret, and report an assay is stored in the easy-access Rotor-Gene AssayManager database. Comprehensive user guidance and well-defined workflows facilitate increased standardization and laboratory productivity. In addition, Rotor-Gene AssayManager supports the latest quality and usability requirements for software, such as 21 CFR Part 11. Rotor-Gene AssayManager enables:

• Operation of up to 4 Rotor-Gene Q cyclers from one computer
• Individual or network installation with remote access
• Convenient and reliable data management
• Secure user management
• Data import/export from QIAsymphony instruments, LIMS, QIAGEN LIMS middleware
• Fully automated analysis and interpretation of results
• Use of an editor to set up user-validated workflows (User Defined Test mode)

Comprehensive user guidance with flexible options

With standardized color schemes, easy-to-understand icons, and comprehensive help and warning messages the user is guided step-by-step through Rotor-Gene AssayManager software.The seamless connection of Rotor-Gene AssayManager to automated upstream sample processing and assay setup with QIAsymphony SP/AS instruments guarantees highest workflow convenience and process safety. In addition, manual up-front processing steps are supported by a special editor, step-by-step procedures, automatic barcode reading, and other features.

Control of up to 4 Rotor-Gene Q cyclers and remote access

Rotor-Gene AssayManager controls the Rotor-Gene Q cycler, i.e., the software will provide all functions to set up, start, and run real-time PCR experiments on up to 4 Rotor-Gene Q cyclers in parallel (see figure "Increased lab efficiency"). This saves laboratory space and increases lab efficiency. Rotor-Gene AssayManager can also be used for experiment setup, result approval, or reporting on computers not connected to a Rotor-Gene Q cycler. In this case, the software can be installed on the user"s office computer enabling convenient result review and approval. Alternatively, a computer in the assay setup room may be used for run setup. This networking capability together with secure database management simplifies a variety of everyday tasks.

Fully automated real-time PCR analysis

Automated real-time PCR analysis is the core function of Rotor-Gene AssayManager. Rotor-Gene AssayManager analyzes the real-time PCR raw data according to well-defined assay specific rules and generates result reports comprising information on the validity or invalidity of the assay and individual samples (see figure "Automated result reporting"). The software provides a special editor to set up all rules and other characteristics for your user defined test.Reliable data management Rotor-Gene AssayManager imports sample-specific information from QIAsymphony instruments, from a LIMS, from a dedicated QIAGEN LIMS middleware solution (in preparation), or from separate Rotor-Gene AssayManager installations. All data from all installations and from all Rotor-Gene Q cyclers in your lab can be stored in a central database. After analysis, approval, and reporting (e.g., as a printout, PDF, or LIMS export), the data are moved to a common electronic archive. For fast and easy data access of all data at each time point, the database is searchable by using various filter functions.

Secure user management

Different user profiles are available and are password protected (user login is required) for increased security. Operators set up and start a run, while administrators are responsible for managing all assets (e.g., cyclers, assay profiles, users) necessary for working with Rotor-Gene AssayManager. Approvers accept or reject the results of a run and release the data of an experiment. Assignment of these dedicated user roles enables optimal use of resources for your laboratory tasks.

Support of 21 CFR Part 11 compliance

Rotor-Gene AssayManager includes specific features that support the technical requirements of 21 CFR Part 11 regulations, enabling use of an electronic records system. User accounts are password-protected according to CLIA requirements and all user actions are documented in an audit trail that can be filtered and printed out. The Rotor-Gene AssayManager audit trail is designed based on guidelines in FDA CFR Title 21, Part 11 Electronic Records, Electronic Signatures.

Software that meets the demands of routine testing applications— today and tomorrow

Rotor-Gene AssayManager standardizes procedures such as cycler control and data storage, helping to reduce the burden of multiple standard operating procedures and simplifying laboratory documentation (see figure "Standardized workflow"). Full flexibility is retained through the use of modular plug-ins that ensure future assays and different assay designs can be run with the workflow already established in your laboratory.

Rotor-Gene AssayManager enables user defined tests using Rotor-Gene Q and QIAsymphony RGQ instruments in routine testing laboratories.