DNA PlateManager^TM software records and reports sample processing in multi-well plates. DNA plate management testing methods have gained wide acceptance and approval as a means to improve the accuracy and specificity of many types of analysis from paternity to forensics; from clinical research and diagnosis to GMO (Genetically Modified Organism) detection and measurement. All these analyses involve common steps, although the origin of sample and the details of each step may vary. Each include extraction, purification, dilution, amplification (PCR or similar) and detection. Most of these steps are carried out in multi-well plates. When the pipeting and diluting is done manually, 96 well plates are used, but modern robotics allows for the greater density of 384 well plates and higher.

As the results of such analysis is often used to make critical decisions in the diagnosis of health problems or the outcome of court verdicts, the history of how each result is obtained must be very carefully and accurately recorded. These records must be made available for stringent audit. These essential details are entered into their laboratory notebooks by technicians, as they are working on the samples. The information is collected from these notebooks and transcribed into official lab reports, where it is approved and distributed to the customers of the laboratory, whoever they may be. The original notebooks must be retained to be examined in the event of any regulatory audit or other legal challenge.

The indexing and storage of many years’ worth of data in multiple lab notebooks is a significant task. The retrieval of any specific details in the event of an inquiry or investigation is timeconsuming at best and incomplete or inaccurate at worst!

With the availability of inexpensive and reliable computer networks and robust relational databases, Laboratory Information Management Systems (LIMS) have long addressed these problems for chemical and physical testing laboratories. However, few if any have been useful to laboratories that process DNA samples. Now PlateManager used with Matrix Plus™ LIMS meets this DNA Plate Management need. Each plate plan has a unique number that is used as the primary identifier for recording the conditions and reagents used to process the samples in that plan. A single plan may contain multiple plates, depending upon the method and the number of samples to be analyzed.

The plate plan number can be system generated or can be entered manually or by canning a bar code if pre-labeled plates are used. Such information as the technician ID, thermo-cycler ID and conditions may be entered along with the buffer, reagent and primer batch information. Any revision made to this information is captured and available for review to support an audit. Within the LIMS, samples are registered and tests are scheduled. These samples may be assigned to a specific technician / analyst as their worklist for that day.

When the analyst enters the PlateManager program they must connect to the LIMS database, hence they enter their name and unique password to identify themselves. When they are registered into the LIMS, the samples that have been assigned to them are presented to them in left-hand window on the PlateManager screen.

The analyst can now build the “Plate Plan” for how the samples, standards, controls etc. are to be loaded into each well of the plate, along with any reagents, enzymes and buffers used. The location of each sample on the plate can be entered manually or automatically, according to user defined rules. A unique “clipboard” function allows for frequently used sample templates to be copied and moved on or between plates.

Once the plate plan is finished, it may be stored, recalled and edited to meet changing sample needs. When required, a “Mark complete” button is available on the PlateManager screen. A click on this button will freeze the plan and no additional changes are allowed. After a plate plan is marked as completed, a hardcopy is printed that contains the unique plan number in bar code format. The technician responsible for actually loading the plates and operating the thermocycler follows this plan.

For analytical methods that separate, identify and quantitate, PCR products by gel electrophoresis, another Matrix option is available. GelManager records how the contents of the PCR plate are loaded into the lanes on the electrophoresis gel. Request the separate datasheet for this option. A comprehensive audit trail is easily produced and FDA 21CFR11 compliance can easily be achieved, where required. All active and completed plate plans are stored in the Matrix LIMS database. Hence it is always possible to determine the detailed history of how any sample was analyzed.

For example:

• Which plate contained a specific sample
• Who processed this plate
• When was this plate processed
• What batch of buffer and reagent was used
• Which thermocycler was used
• What were the conditions

Hence information to support a result is always readily accessible without sorting through piles of paper records and old laboratory notebooks.

Availability and compatibility

• PlateManager is currently available as an optional module to be used with Matrix Plus and Matrix Enterprise.
• It requires Matrix 3.02 or higher.
• It will operate on Windows 95, 98, NT or 2000.
• It can be installed on a single workstation or on a network.
• Matrix Plus can use most ODBC databases. The most popular are Microsoft SQL Server and Oracle.

GelManager, PlateManager and Matrix Plus are trademarks of Autoscribe, Ltd.
Windows, SQL Server, Access are trademarks of the Microsoft Corporation.
Oracle is a trademark of Oracle Corporation.

Contact Autoscribe now for further information .