Introduction, Software packages – Luminex xPONENT 3.1 User Manual

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CHAPTER 1

Introduction

The Luminex system was developed to improve workflow and efficiency in the clinical
laboratory and in research and development. End users in the laboratory must run
microtiter plates using xMAP

®

based assay kits developed for use with xMAP technology.

Software Packages

xPONENT

®

software has different levels of functionality:

1. Allows you to perform analysis, create protocols and batches, review and print reports,

and perform Luminex system maintenance.

2. Instrument Control - Allows the application to connect to and communicate with an

instrument identified by a specific serial number. Protocols and batches can be
exported for use with an Instrument Control-enabled software package.

3. Secure - Includes all of the Basic functionality, as well as administrator-controlled user

permission levels.

4. 21 CFR Part 11 - Includes all of the Secure functionality as well as requiring electronic

signatures to perform certain tasks. Electronic signatures are listed in the system log.
Electronic signatures for batch functions are also listed in the batch audit log.

5. Automation - Includes the ability to communicate with external hardware.

6. Remote Web Monitoring - Allows you to view alerts and system status using a

webpage.

7. LIS - Includes the ability to communicate with an external Laboratory Information

System (LIS) database. The LIS edition

allows the export of patient result data in

ASTM file format and the import of patient sample information in ASTM format.

8. Allelic Ratios - Allows allelic ratios to be used.

You will need an instrument control license to operate the instrument.

For more information on purchasing upgraded packages or to obtain specific package
documentation, contact your vendor.

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