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A complete system for Unscheduled DNA Synthesis assays

Perceptive Instruments have supplied pharmaceutical companies and contract research organisations with image analysis and data processing solutions for regulatory genetic toxicology assays for a decade.

For Unscheduled DNA synthesis we have a flexible approach geared to specific needs based upon our Sorcerer automatic image analysis system.

Sorcerer consists of an imaging board which resides in the computer and a monochrome CCD camera attached via a C-mount adapter to the microscope. The live image of the cells as seen by the camera is displayed on the monitor.

An easy to use interface based around Sorcerer

The system consists of a series of modules for creating studies, randomisation, slide scoring, data saving and production of experimental summaries. Slide scoring can be based either on direct or indirect counts and the analysis of one or more cytoplasmic areas. The person scoring the slide is guided throughout the procedure including calibration where necessary and all events are fully audited.

Using a three button mouse, the user positions the circular measurement frame on the first cell to be measured and matches the frame boundary to that of the nucleus. A click on the third button initiates a measurement cycle which includes automatic detection of grains taking into account the background stain intensity and shading. The frame is then moved to the cytoplasm and one, or more measurements taken in different regions. Detected grains can be highlighted with a coloured overlay and/or individual count flags.

Results & regulatory requirements

Sorcerer includes a special algorithm for separating overlapping grains to provide direct counts. Alternatively, grain area can be measured for subsequent computation of an indirect grain count. Measurements are accumulated for each slide and transferred directly using OLE links to Microsoft Excel. A standard template file is available so that clients can produce results tables to their own format. Data may also be sent directly to Microsoft Access or Oracle database tables.

Sorcerer is designed to conform to international GLP's and other regulatory requirements. Encoded audit trail files automatically record all system activity and data. It is fully compliant with the FDA 21 CFR Part 11 Final rule on electronic records and electronic signature.

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