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.
Features of Sorcerer UDS
- Secure password management, forced entry of reasons, GLP & FDA compliance
- Flexible study design incorporating up to 8 experiments
- Optional reserved slides as back-up for additional data collection
- Slide randomisation and de-coding
- Interactive scoring with prompts and calculation of net grain on a cell by cell basis
- Direct and mean grain area count modes with calibration sequence
- Encoded, secure raw data and audit trail files
- Experimental summary to view data for each slide or experiment
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 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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