Chapter 1 introduction, Software packages, Introduction – Luminex xPONENT 4.0 SP1 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. Basic - Basic package allows you to perform analysis, create protocols and batches

(both of which can be exported for use with an Instrument Control enabled software
package), review and print reports, and perform Luminex system maintenance.

2. Instrument Control - This configuration allows the application to connect to and

communicate with an instrument identified by a specific serial number.

3. 500 Analyte Support - This configuration gives access to run or replay a batch that

contains up to 500 analytes.

4. Secure - Has all of the Basic functionality, plus allows the administrator to set up user

permission levels.

5. 21 CFR Part 11 - Has all of the Secure functionality, plus allows the requirement of

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.

6. Automation - Has the ability to communicate with external hardware.
7. Remote Web Monitoring - Allows you to view alerts and system status via a webpage.
8. LIS - Has 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.

9. Allelic Ratios - A feature enabling allelic ratios to be utilized.

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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