® MAGPIX User Quick Guide For In Vitro Diagnostic Use
© Luminex Corporation, 2011. All rights reserved. No part of this publication may be reproduced, transmitted, transcribed, or translated into any language or computer language, in any form or by any means without prior express, written consent of Luminex Corporation. LUMINEX CORPORATION 12212 Technology Boulevard Austin, Texas 78727-6115 U.S.A.
MAGPIX® User Quick Guide ii For In Vitro Diagnostic Use
Table of Contents Chapter 1 Starting the MAGPIX System for the First Time .............................................1 Starting xPONENT .......................................................................................................................................1 Start-up Indicators .......................................................................................................................................1 Log On to xPONENT .............................................................
MAGPIX® User Quick Guide iv For In Vitro Diagnostic Use
Chapter 1: Starting the MAGPIX System for the First Time Detailed instructions on how to install the MAGPIX System are provided in the PC Installation Instructions (89-30000-00-263) and Installing MAGPIX (89-30000-00-236) foldouts that you received with the instrument. This manual provides step-by-step instructions on how to start your MAGPIX system for the first time, how to perform daily operations, and how to properly maintain the instrument.
When you turn on the Luminex MAGPIX system, the following start up indicators occur: • Blue light indicator turns on. • Fans turn on. • Syringe pump initializes. • The filter wheel initializes. • Software connects to the instrument. NOTE: It may take several minutes for the instrument to initialize and connect to the software. The Software Connectivity indicator is located on the lower left corner of the software screen.
1. On the Home page, click Probe and Heater under Daily Activities. The Probe & Heater tab opens. 2. Based on the type of plate you are using, place alignment disks or an alignment sphere from the Height Alignment Kit in the well. NOTE: Luminex recommends that you use well D6 (this is the center of a standard 96-well plate). • Filter-bottom plate - two (2) 5.08mm disks • Mylar-bottom plate - two (2) 5.
CAUTION: Correct sample probe height is critical to successful sample acquisition and calibration. Problems with the sample probe can lead to fluid leaks and inhibit sample acquisition. To adjust the height of the sample probe, follow the steps above. FIGURE 1. Sample Probe Height Adjustment 1. Well D6 2. Strip well SD1 3.
1. Open the Maintenance page, then the Cmds & Routines tab. 2. Select Revive After Storage (Luminex) from the drop-down list. The Revive After Storage routine performs the following commands: • Prime • Rinse • Alcohol Flush • Rinse 3. On the Cmds & Routines tab, select Prime from the Commands option section and perform a Prime. 4. Add 70% isopropanol or ethanol to reservoir RB1 on the off-plate reagent block as indicated on the Cmds & Routines tab. NOTE: The rinse reservoir (RD1) should be empty. 5.
System Initialization System initialization prepares the system for data acquisition. On initial startup, the System Initialization should consist of: • Fluidics Prep • Calibration • Performance Verification Calibration normalizes the settings for the system and ensures optimal and consistent microsphere classification. Verification uses system controls to ensure that the analyzer is functioning properly with current calibration settings. 1. On the Admin page, select the System Setup tab. 2.
1. Load the CAL/VER CD (provided with the kit) on the computer. 2. On the Home page, click System Initialization. 3. Click Import Kit at the bottom right side of the window. The Import Calibration or Performance Kit dialog box opens. 4. Select Locate the CD in the appropriate drive and select the *.mpx folder and click Open. 5. Select the *.lxl file and click Open. 6. Click OK. Creating Calibration and Verification Reports 1. Open the Results page, then open the Reports tab. 2.
MAGPIX® User Quick Guide 8 For In Vitro Diagnostic Use
Chapter 2: Daily Start-Up Activities Defining the System Initialization Routine NOTE: Luminex recommends daily performance verification and weekly calibration of the MAGPIX system. You can set up the system initialization routine to include calibration and verification under the Admin page, System Setup tab, Maintenance Options section. 1. Open the Admin page. 2. Click System Setup. 3. Under Maintenance Options, select Fluidics prep, performance verfication from the drop-down list. FIGURE 3.
1. On the Home page, click System Initialization under Daily Activities. The Auto Maint tab opens. 2. On the Auto Maint tab, the System Initialization option is automatically selected. 3. Verify that the correct lot kit is displayed in the Calibration and Performance Verification drop down field and that the correct reagents (Ex: VER and Fluidics reagents) have been added to the off-plate reagent block. 4. Fill reservoir RB1 3/4 full of 70% isopropanol or ethanol. 5.
Chapter 3: Running Assays Creating a Kit To create a kit: 1. Open the Protocols page, then open the Protocols tab. Select the protocol that you want to use for the kit, then click NewStd/Ctrl. The Std/Ctrl Details tab opens. 2. Click on the protocol that you want to use for the kit, then click New Std/Ctrl. The Std/ Ctrl Details tab opens. 3.
1. Open the Protocols page, then open the Protocols tab. Click the Stds & Ctrls tab, then click Create New Std/Ctrl Lots. 2. In the Select Protocol dialog box, select the protocol you want to use for this lot, then click OK. The Std/Ctrl Details tab opens. 3. If the protocol uses standards, type the appropriate information for each standard in the Assay Standard Information section. In each analyte column, type the expected concentration for the analyte. 4.
5. If you want a description for the batch, type it in the Enter Optional Description box. • Click the existing protocol that you want to use. If the protocol uses standards and/or controls, you can view the active reagents. If the selected protocol uses standards/ controls, the next tab that appears is the Stds & Ctrls tab. You can view details about the active reagents, apply different standards/controls, or manually add new information on this tab.
6. Click Generate. The report appears in the lower part of the Reports tab. 7. Click Print to print the report, or Save to save the report as a PDF file. FIGURE 5.
Chapter 4: Shutdown Shutting Down the Analyzer Run the daily shutdown routine to prevent clogs and crystallization of salt in the sample probe. Clogs and crystallization of salt in the sample probe may cause problems with calibration, verification, and data acquistion; they may also cause sample splashing. Shut down the system properly to ensure system integrity. 1. On the Home page, click Shutdown. The Auto Maint tab opens, with System Shutdown selected. 2. Click Eject. 3.
MAGPIX® User Quick Guide 16 For In Vitro Diagnostic Use
Chapter 5: Troubleshooting MAGPIX New System Initialization Troubleshooting This section provides you with information to troubleshoot issues that may be encountered during the MAGPIX® installation and system startup. The procedures are presented as stepby-step instructions and assume basic knowledge of xPONENT software and xMAP Technology. System Startup Verify that the following procedures were performed when the MAGPIX system was turned on for the first time.
1. Adjusting the Sample Probe Height 2. Revive After Storage Routine (Luminex) 3. System Initialization All system startup routines are run from the MAGPIX Off-Plate Reagent Block. For detailed instructions on how to perform these operations, refer to the Starting the MAGPIX System for the First Time section of this manual. FIGURE 6.
Problem Summary Resolution Notes If Calibration continues to fail run the following routine: Create routines in the xPONENT “Maintenance” Tab “Cmds & Routines” page Approx run time: Five mins (1x) Clean with 0.1 N NaOH (reservoir C) (3x) Rinse (reservoir D) Run Calibration Routine Verify that reagent is freshly vortexed. Use 6 drops of reagent. If problem is not solved, contact Luminex Technical Support Performance Verification Failing Sonicate and flush the sample probe.
Problem Summary Resolution Notes (1x) Sanitize with 0.1N NaOH (reservoir C) (2x) Clean with 0.1N NaOH (reservoir C) (2x) Rinse (reservoir D) (1x) Alcohol Flush with70% isopropanol or ethanol alcohol (reservoir B) (1x) Prime (4x) Rinse (reservoir D) CAL (strip well A) Verify that reagent is freshly vortexed. Use 6 drops of reagent. (3x) Rinse (reservoir D) VER (strip well B) Verify that reagent is freshly vortexed. Use 6 drops of reagent.
FIGURE 7.
MAGPIX® User Quick Guide 22 For In Vitro Diagnostic Use
Chapter 6: Technical Support On the Web For more information, visit the Luminex FAQ page at http://www.luminexcorp.com/support/. You can access the Technical Support website using a user name and password at https:// oraweb.luminexcorp.com/OA_HTML/jtflogin.jsp. By Phone Inside the U.S. and Canada Phone: 1-877-785-BEAD (-2323) Fax: 512-219-5114 By Phone Outside the U.S. and Canada +1 512-381-4397 Email Email questions to support@luminexcorp.com.
