Medusa 2000

Sanguin Aurora

Operating System

MS-DOS.

Will operate through a DOS window on a Windows platform.

Windows ‘95/98/NT

True 32 bit application.

Hardware

Stand-alone PC or Networked PC’s.

Stand-alone PC or Networked PC’s.

Systems placed since launch

1500+

(launched 1991)

60+

(launched Q3 - 1999)

Assay Applications

• Qualitative ELISA
• Quantitative ELISA
• Blood Grouping
• Haemagglutination
• Kinetics
• Image Analysis

• Qualitative ELISA.
• Quantitative ELISA.
• Blood Grouping.
• Haemagglutination.
• Image Analysis.
• Kinetics.

(N.B. : Improved EIA module allows ‘complex’ user defined assay calculations such as those used in neutralisation/confirmatory assays.)

Controls can be renamed throughout the assays, fulfilling the latest FDA requirements for the naming conventions of controls versus calibrators.)

Help screens

(on-line help)

Yes

Basic text display

Yes

Full Windows style help screens with hypertext, word search etc.

Full use of ‘tool tips’ for all buttons and active areas.

Result Validation Module

Yes

Allows results to be trapped and validated based on:

• Series of results
• OD’s (high/low)
• Ratio’s
• Pipetting Errors
• Failed Controls
• Assay to Assay Confirmation

Menu triggered function only.

Yes

Allows results to be trapped and validated based on:

• Series of results
• OD’s (high/low)
• Ratio’s
• Pipetting Errors
• Failed Controls
• Assay to Assay Confirmation

Menu triggered, or can now be linked to an assay so that it can be automatically triggered as part of the plate filing process.

Monitor Module

Yes

Allows for interfacing to devices such as pipettors/plate processors, but is menu driven. Because of the limitations of DOS it cannot operate as a background task.

Yes

Allows for interfacing to multiple devices such as pipettors/plate processors, but is now a true background task. It can be menu activated or can be left operating in the background at all times.

Database

B+trieve

Uses ODBC compliant database structure.

Comes complete with Microsoft Access as the default database type.

SQL Server Database version is also available for medium to large network applications.

Allows for simultaneous multiple database operation (e.g. separate training database area and clinical test database).

All ODBC databases have their own advanced external database repair and compact facilities.

Sample recall/Sample History

Yes

- via multiple menus.

Yes

- Simple menu allows the user to view current results, sample history, view plate data, worklist status etc. all through a single data entry point.

Same entry point also allows date based, plate based or batch based searches.

Menu Groupings

Yes – but given the age of the product the menu’s now look ‘cluttered’ as options have been added over the years.

Menus are text based.

Menu’s reworked into logical groupings of:

Main : all routine and basic functions. No system or assay configuration functions.

Configuration: all assay, report and instrument configuration.

Manager: Password and database management and audit trails.

All displays are graphic based, using both menu’s and icons as means of system navigation.

Documentation

Medusa 2000 obtained FDA 510(k) in 1994, but current regulatory requirements for documentation are now more stringent.

All documentation meets FDA 1999 expectations, including fully cross-referenced:

• Master Requirements
• Detailed Software Functional Specifications (SFS)
• Detailed Test Plans for each SFS
• Full test plan execution (record of testing)

FDA

510(k) cleared for EIA (1994) and Blood Grouping (1998)

510(k) cleared for EIA and Blood Grouping (1999)

I/O’s

Contains extensive range of instrument interfaces to

• Readers:

• Sample Preparation Devices (SPD’s)

• Microplate Processors (MPP’s)

Contains extensive range of instrument interfaces to

• Readers
• Sample Preparation Devices (SPD’s)
• Microplate Processors (MPP’s)

Assay locking

Yes

• via external ‘Distributor’ disk.

Yes

• internal (i.e. menu function within Aurora).

Validation locking

No

Yes

• internal (i.e. menu function within Aurora).

Transfer of assay/report/

validation protocols

Yes

• via external ‘Distributor’ disk

Yes

• internal (i.e. menu function within Aurora).

Translatable

Yes – can be translated into local language by the user.

Yes – can be translated into local language by the user. The system allows for more than one language to be used, catering for bi and multi-lingual countries.

User security

Yes

• User names, passwords and access to menus controlled by system manager.

Yes

• User names, passwords and access to menus initially controlled by system manager.
• Users can change their own password
• auto-expiry of passwords if required.
• Also allows for assay specific restrictions as well as menu restrictions.

Audit Trail

System keeps history of sample testing.

System keeps full history of:

• sample testing, who created/changed result, times dates etc.
• full plate history, even if plate is read then abandoned prior to filing.
• Full user audit trail showing all user activities within the software.

Plate/Assay Formats

96 well microplate

• 1x6
• 1x8
• 24 well
• 96 well
• 384 well

Worklisting

Allows some basic worklisting.

Works lists can be imported and/or exported on a user definable basis.

Reporting

User defined reports or serial outputs. Text based only

• User defined reports or serial outputs.

• Activation of the report can be linked directly to the filing of plate results (as can result validation).

• Reports can be ‘print previewed’.

• User can incorporate graphics/images within reports (e.g. logo’s etc) – full use of Windows fonts, colors etc.
• Data can be sent to a simple ASCII file or out via a serial port as well as the printed format.