xPONENT for MAGPIX Software User Manual IVD
© 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.
Standard Terms and Conditions for Use of Instrument Product By opening the packaging containing this product ("Product") or by using such Product in any manner, you are consenting and agreeing to be bound by the following terms and conditions. You are also agreeing that the following terms and conditions constitute a legally valid and binding contract that is enforceable against you.
hardware not provided by Luminex. If Product is purchased from a Luminex authorized reseller, any warranty obligations shall be provided in writing directly by such Luminex authorized reseller to Buyer. THIS WARRANTY IS EXCLUSIVE AND LUMINEX MAKES NO OTHER WARRANTY, EXPRESS OR IMPLIED, INCLUDING WITHOUT LIMITATION ANY IMPLIED WARRANTY OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE.
indicated on the Product label, the Product has not received approval from the United States Food and Drug Administration or other federal, state or local regulatory agencies and have not been tested by Seller or Luminex for safety or efficacy in food, drug, medical device, cosmetic, commercial or any other use, unless otherwise stated in Seller's technical specifications or material data sheets furnished to Buyer.
contract or any other theory of law or equity arising out of, directly or indirectly, the use of the Product or by reason of Buyer's failure to perform its obligations contained herein.
End-User License Agreement (EULA) for Luminex® Software This Luminex End-User License Agreement (“EULA”) is a legal agreement between you (either an individual or a single entity, also referred herein as “you”) the end-user and Luminex Corporation (“Luminex”) regarding the use of the xPONENT software product provided to you above, which includes computer SOFTWARE and online or electronic documentation and may include associated media and printed materials (if any) (“SOFTWARE”).
3. GRANT OF LICENSE. Subject to the terms and conditions of this EULA, Luminex hereby grants to you a nonexclusive, nontransferable, nonassignable license (without right to sublicense) under Luminex’s copyrights and trade secrets to use the SOFTWARE on a single computer running with a single unit of a specific model of Luminex instrument, as such model is identified on the packaging included with the SOFTWARE. You may make one (1) copy of the SOFTWARE for backup or archival purposes only.
5. TERM AND TERMINATION. Your rights under this EULA are effective until termination. You may terminate this EULA at any time by destroying the SOFTWARE, including all computer programs and documentation, and erasing any copies residing on your computer equipment. Luminex may terminate this EULA upon thirty (30) days written notice to you. Your rights under this EULA automatically terminate without further action on the part of Luminex if you do not comply with any of the terms or conditions of this EULA.
Table of Contents Chapter 1 Introduction ........................................................................................................1 Software Packages ......................................................................................................................................1 About This Manual .......................................................................................................................................2 Warnings, Notes and Symbols ...........................
Using Online Help ......................................................................................................................................32 Screen elements ........................................................................................................................................32 System Monitor ..........................................................................................................................................34 Home Page ....................................
Revive After Storage Routine ..............................................................................................................89 Calibration/Verification Routine ...........................................................................................................90 Daily Activities ............................................................................................................................................91 Defining the System Initialization Routine ........................
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Chapter 1: Introduction Luminex® xPONENT® for MAGPIX® (xPONENT 4.1) IVD software was developed to improve workflow and efficiency in the laboratory. Designed for ease-of-use, xPONENT enables both new and advanced users to set up and run assays in a minimal amount of time. This manual describes the features and functions of xPONENT for MAGPIX. To ensure that you have the most up-to-date version of this manual, visit http://www.luminexcorp.com/ support/tech_manuals.html.
About This Manual The conventions in this manual assume a basic familiarity with computers and a knowledge of Microsoft® Windows® software. Commands are often available through more than one method, for example, from the toolbar and from menus that appear when right-clicking an area of the screen. However, for ease of use, the procedures in this help describe only one method for accessing commands. Warnings, Notes and Symbols The following informational notes and warnings are used in this manual.
CAUTION: Modifying or deleting xPONENT system files may cause degradation of system performance. You can repair modified or deleted xPONENT system files by uninstalling and re-installing the xPONENT software. Luminex recommends that you contact Technical Support before uninstalling and re-installing xPONENT CAUTION: Using unauthorized third-party software with xPONENT software may result in corruption or failure of the xPONENT software. Use third-party software at your own risk.
NOTE: Refer to the product information sheet that accompanies your IVD assay for additional information. CAUTION: Do not use strong organic solvents with MAGPIX. For information about specific compatibility, visit the Luminex Technical Support website at http://www.luminexcorp.com/ support/faqs.html. Safety Precautions WARNING: All samples should be regarded as potentially contaminated and treated as infectious.
normalizes the settings for the classification channels (CL1 and CL2) and the reporter channel (RP1). Use the Luminex MAGPIX Calibration Kit to accomplish this. Following calibration, use the Luminex MAGPIX Performance Verification Kit to check all of the optical channels in the system for correct calibration. It is essential to verify every time you calibrate. If there is a problem with optical integrity or fluidics, MAGPIX may pass calibration but fail performance verification.
Classification and Reporter Fluorochromes MagPix beads in the calibration kit are used to autofocus the camera and calibrate the CL1, CL2, and RP1 channels. The beads in the verification kit are a mix of 6 different regions that cover the range of the 50-plex map. Both calibration and verification beads are triple-dyed, and the fluorescence signal of these dyes enables classification of each bead set. TABLE 1.
when the analyzer flushes the sample lines after sample acquisition and expels approximately 75 µL of sample back into the well. Examples • If you use a sample volume of 50 µL and aspirate 50 µL, you will acquire air bubbles. • If you use a sample volume of 200 µL and a standard sample pickup of 50 µL, the well will overflow when the analyzer washes the sample lines after acquisition and expels fluid back into the well, because the amount of fluid expelled back into the well is approximately 75 µL.
xPONENT for MAGPIX 8
Chapter 2: Application Administrator Tasks System Setup If you have a secure version of xPONENT for MAGPIX, you must have xPONENT administrative privileges to perform System Setup tasks. If you do not have a secure version of xPONENT for MAGPIX, all users may be able to perform system setup tasks. To view administrative options, click Admin on the navigation bar.
FIGURE 2. System Setup Tab Viewing System Status The System Monitor displays at the bottom of all xPONENT windows. It displays the physical state of the Luminex system. Values are reported directly from the Luminex system. Application Settings These settings change graphical user interface (GUI) preferences. Enable Virtual Keyboard - Enables the touchscreen virtual keyboard. Allow the application to be minimized - Enables you to minimize xPONENT so that you can access the desktop.
LIS Settings You must have the LIS version of the software to perform this task. To connect to the LIS, check Connect to LIS. In the Watch folder for incoming orders box, browse to the location where xPONENT should watch for incoming orders. Select the options you want to enable in the software and click Save. External Analysis Program Settings Use this option if you are using a program other than xPONENT to analyze collected data.
FIGURE 3. New External Analysis Program Dialog Box Adding an External Analysis Program 1. If the program is on an external media source such as a CD or flash drive, insert the media into the appropriate drive on the PC. 2. Click Add New to open the New External Analysis Program dialog box. 3. Type a name for the external analysis program. 4. Click Browse to navigate to the .exe file for that program. Double-click the file name. 5.
Editing an Analysis Program 1. In the Installed Analysis Programs list, click the program you want to edit. 2. Click Edit. The Edit External Analysis Program dialog box opens. 3. Edit the Name, Path, or Command Line Parameters, or make this the default analysis program if there are two or more programs installed. The default analysis program name displays in bold text. Removing an Analysis Program To remove an analysis program from the Installed Analysis Programs list: 1.
NOTE: The 21 CFR Part 11 package also provides full access to the Secure Package functionality. FIGURE 4. Group Setup Tab Users are assigned to groups. These users then have permissions granted to their group. NOTE: Assign permissions directly to an individual by assigning the user to a specific Group Profile on the User Setup tab.
Group Features - The Group Features list contains permission categories. When you select a category from the list, the Features section displays the individual tasks that are a part of that category. The following categories are available • System Administration • Batch Management • Protocol Management • Lot and Std/Ctrl Kit management • Import and export data • Archiving The Allowed check box next to the desired permission in the Features section enables the selected group to perform that task.
• Export Processed Batch Results • Change Sample Load Volume During Run Protocol Management Delete Protocol Lot and Std/Ctrl Kit management • Create Std/Ctrl Kit and Lots • Edit Std/Ctrl Kit and Lots • Delete Std/Ctrl Kit and Lots Import and Export Data • Export Batch, Protocol, Kit or Lot Files • Import Batch, Protocol, Kit or Lot Files Archiving • Backup/Restore • Import/Archive When you or any user perform an action that requires an electronic signature, the Electronic Signature dialog box opens.
Buttons to delete or edit settings for a selected user. User Setup Tab Use this tab to create or edit a user account, remove a user from the system, or view a list of authorized users, along with their profile details. You must be using either the 21 CFR Part 11 or Secure package of the software to perform user setup tasks. FIGURE 5. User Setup Tab This tab contains the following. Create New User - Click to open the Create User Account screen. Global User Settings - Settings common to all users.
Defining Global User Settings 1. In the Global User Settings section, type a length of time (in days) for the Password Expiration. The default is 180 days. 2. Set the number of allowed Unsuccessful Login Attempts. After this number of failed attempts to log in, the user’s account is locked. 3. Set how many seconds pass before an Automatic Logoff is initiated. 4. Type the Minimum User ID Length. The default minimum User ID length is six characters. 5. Type the Minimum Password Length.
Creating a New User 1. Click Create New User. The Create User Account screen opens. 2. Type the user ID in the User ID box. The user ID is not case-sensitive. You can change the required number of characters required for a user ID on the User Setup tab. Once you create and delete a user ID, you cannot use that user ID again. 3. Type the user’s name in the User box. 4. Select the Account Status check box to lock the account, or clear this check box to unlock the account.
FIGURE 7. Batch Options Tab Batch Options. This section displays the following options: • Allow running a batch with expired reagents - Allows batches to run with expired reagents. • Allow running a batch if XY temperature is not in range - Allows batches to run if the XY temperature is not in range. • Allow running a batch if the instrument is not calibrated or verified - Allows batches to run if the instrument is not calibrated.
• Minimum bead count for obtaining results - Type any whole number from 0 to 1000000. This is the minimum bead count that must be observed by the instrument for a particular analyte before this data is used in statistical calculations and is displayed on the graphs and results table. This number varies based on assay. When set to a number greater than 0, the analyzer does not display data for bead sets not generating events equal to or less than this value. Type 0 to display all events.
FIGURE 8. Alert Options Tab Alert Options - Offers three check boxes for each alert - Dialog, Email, and Sound. This section displays the following events: • Locked User - The user's account is locked and must be unlocked by an administrator. • Batch Complete - The batch run is complete. • Heater In Range - The plate heater is warmed to the designated range. • Scheduled Maintenance - A scheduled maintenance routine is now due.
Setup Email - Opens the Setup Email Dialog box FIGURE 9. Setup Email Dialog Box Enable or disable email notification by selecting or clearing the Email Active check box. Contact your network administrator to determine the information needed in the Mail Server Host, From Email Address, From Email Password, and Mail Server Port boxes, and if you need to select the Enable SSL (Secure Sockets Layer) check box The Test button tests the email settings.
4. If you choose to send an email notification for a specific event, and the email address is not already set up, click Setup Email at the bottom of the page to open the Setup Email dialog box. • Turn email notifications on or off by checking or clearing the Email Active check box at the bottom of the screen.
FIGURE 10. CSV Options Tab Automatically export results CSV file when batch is complete - Automatically export results CSV file when batch is complete - Automatically exports the CSV file when the system finishes analyzing the batch. This allows running programs on exported data without having to manually start the export. Automatically export batch when batch is complete - Exports batch information automatically when a batch has completed.
Cancel - Cancels changes. Save - Saves changes. Setting CSV Options 1. In the CSV and Batch Export Options section, select the options you want to apply to the CSV file. If you select Maximum number of data columns in CSV file, type a maximum number of columns. 2. In the CSV File Export Folder and Automatically Exported Batch Folder box, type the location to which you want the file sent, or click Browse to navigate to the folder. 3.
• File Type - Choose from Protocols, Batches, Std/Ctrl Kits, Lots, Patient Samples, or Log. The selected information appears in the list below the Archive Folder path. • Keep data after archive - Retains data instead of deleting after you archive it. • Exclude Raw Data Files - Select this option if you have selected Batches in the File Type list to exclude files that contain only raw data. • Browse- Chooses the network or local PC destination folder for the exported archive file.
5. To exclude raw data files from the archive (suggested if you are archiving Batches) select Exclude raw data files. 6. Click Archive. The command executes. When complete, an Archive Successful dialog box opens. To delete a partial batch, open the Admin page, then click the Archive tab. Clear the Keep data after archive box. Click Archive to delete the partial batch. NOTE: To delete a partial batch, open the Admin page, then click the Archive tab. Clear the Keep data after archive box.
Schedule Tab Use the Schedule tab to enable or change the recurrence of scheduled maintenance reminders. FIGURE 12. Schedule Tab • Select the time of day that you want to receive alerts in the Alert Time list. • Select how often you want to receive reminders in the Recurrence list. • Enable or disable the reminders by selecting or clearing the Enabled check box. Report Options Tab Use this tab to add your company information and logo to reports.
FIGURE 13. Report Options Tab • Type a company name in the Company box, and any additional information in the Info: box. • Click Import Logo and then Open after navigating to the desired file to import a graphic for the report header. NOTE: Use a logo file with 920 x 125 pixels. To make the logo to appear to the right of your company name, include 120 pixels of white space to the left of the logo, in the graphic file; otherwise, the logo may appear behind the company information.
Chapter 3: Using xPONENT Starting xPONENT Perform the following steps if xPONENT does not launch automatically after starting you turn on the computer. • On the PC desktop, click the Luminex xPONENT icon, or click Start > Programs > Luminex > xPONENT > Luminex xPONENT • If you have a trial license, click OK in the dialog box that opens. • If this is the first time you have started the software, the User License Agreement may display. Read the license agreement.
xPONENT must read this manual thoroughly before operating the software. 1. On the System Login tab, type your user ID. 2. If you are using a secure version of the software, type your password. The Home page opens. Logging Off of and Exiting xPONENT 1. Click Log Off. 2. Click OK in the Confirm Logout dialog box. If you do not want to exit the software, stop here. To exit all of the way out, continue with step 3. 3. Click Exit. 4. In the Do you want to exit the software now? dialog box, click Yes.
FIGURE 14. Screen Elements 1. Page 2. Tab 3. Right-Click Menu Page The main elements at the top of the window are Pages. Click a page to go to that page in the software. All of the pages except the Home page, and in some cases the Admin page, can be moved or deleted. Tab The elements on the left side of the window are Tabs. Click a tab to display information and tasks on that tab. Some tabs are numbered and must be completed sequentially.
• Copy All - Copies all data • Copy - Copies only selected data • Paste - Pastes previously copied text or data into the box • Delete - Erases text or data from the selection System Monitor The System Monitor displays at the bottom of all xPONENT windows. It displays the physical state of the Luminex system. Values are reported directly from the Luminex system. FIGURE 15. System Monitor 1. System Status Button 2. Connection Status 3. Command Display 4. Progress Bar and Buttons 5. Eject XY Button 6.
Pause - Pauses the system after the current command completes. Pause does not stop the system in the middle of running a command. You cannot run another command while the system is paused. Stop - Stops the system, regardless of command status. Eject - Ejects the plate. Once the plate is ejected, the Eject button changes to Retract. Retract retracts the plate, and the Retract button changes back to Eject.
FIGURE 16. Home Page Daily Activities System Initialization - Perform a system initialization routine. Shutdown - Perform a shutdown routine. Probe and Heater - Adjust the probe height or plate heater. Drive Fluid Lot - Enter the Drive Fluid lot number, which is printed on the box in which the fluid container was shipped. This information is optional. Create a New Batch from the highlighted Protocol below - Creates a new batch using a selected protocol from the Installed Protocols list.
Adjusting the Sample Probe Height Adjust the sample probe height to ensure that the probe drops far enough into the well to acquire sample. NOTE: Ensure that there is no liquid in the wells or reservoirs before adjusting the sample probe height. 1. On the Home page, click Probe and Heater under Daily Activities. The Probe & Heater tab opens. 2.
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 17. Sample Probe Height Adjustment 1. Well D6 2. Well D1 3. Well RB1 System Initialization xPONENT for MAGPIX contains a pre-defined startup routine to prepare the analyzer for data acquisition.
Calibrate your system at least once a week using the Calibration/Verification button on the Auto Maint tab of the Maintenance page. In addition, recalibrate the system if: • The delta calibration temperature exceeds ± 5° C. • You move the instrument. • You experience sample acquisition problems. Verify the system daily using the Performance Verification button on the Auto Maint tab of the Maintenance page. Refer to your assay kit instructions for additional calibration frequency requirements.
FIGURE 18. Select System Initialization Routine Running System Initialization 1. On the Home page, click System Initialization under Daily Activities. 2. Select the Calibration Kit active (current) lot number from the list. 3. Select the Performance Verification Kit active (current) lot number from the list. 4. Vortex the calibration and verification beads for twenty seconds. Do not dilute the reagents. 5. Click Eject on the Status Bar. 6. Place the off-plate reagent block on the heater plate. 7.
Deleting CAL and VER Kit Information 1. Open the Maintenance page, then open the Lot Management tab. 2. In the Active Reagents section, select the kit you want to delete from the Calibration Kit or Performance Verification Kit lists. 3. Click Delete Kit. CAUTION: There is no confirmation dialog box when you delete a kit. Creating Calibration and Verification Reports 1. Open the Results page, then open the Reports tab. 2. In the Report drop-down list, select Calibration and Verification Reports. 3.
• Protocols - Displays when Create a New Batch from an existing Protocol is clicked. • Stds & Ctrls - Displays when Create a New Batch from an existing Protocol is clicked. • Plate Layout - Displays when Create a New Batch from an existing Protocol is clicked. • New MultiBatch - Displays when Create a New Multi-Batch is clicked. NOTE: These tabs (except New MultiBatch) are sequential. You must complete each screen in a specific order. FIGURE 19.
Export - Exports a batch Delete - Deletes a batch. Edit - Edits a batch. Run - Runs a batch. Using the Batches Page 1. Open the Batches page. 2. Click one of the following: • Create a New Batch from an Existing Protocol • Create a New Multi-Batch 3. Type the batch name in the Batch Name box. 4. Type an optional description of the batch in the Enter Optional Description box. 5. If you are creating a batch from an existing protocol, select the protocol in the list. Click Next.
NOTE: Luminex recommends that you analyze the manufacturer’s assay kit controls with each batch. To create a new batch from an existing protocol: 1. Read the instructions provided with the assay kit you are using. 2. Open the Batches page. 3. Click Create a New Batch from an existing Protocol. 4. Type the batch name in the Batch Name box. 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.
9. Type a unit of measurement in the Units box. 10. Type the desired bead count for each analyte in the Count box. 11. If you click Apply All, this applies to all analytes. 12. To change individual units or counts, change them in the analyte table. 13. Type the desired bead count for each analyte in the Count box. 14. Click Next. The Stds & Ctrls tab opens if you selected an analysis type other than None. • If you are using an assay standard/control kit, click Apply Std/Ctrl Kit.
FIGURE 20. New Multibatch Tab This page contains the following: Multi-Batch Name - Use this field to create a name for new multi-batches. Select Pending Batch - Contains a list of all pending batches. This list includes name, protocol, protocol version, date, and status information for each pending batch. Select the batch you want to add to the plate. Click OK. A plate layout diagram automatically populates the wells for the batch.
6. Click Save to return to the New Multibatch tab. 7. Click Run to run the multi-batch. FIGURE 21.
FIGURE 22.
FIGURE 23. Multibatch Report Dialog Box Save Multi-batch After creating a multi-batch, you can save it to the Select Pending Batch list. When saved to this list, the protocol appears as “Multibatch.” Batches saved to a multi-batch cannot be edited or deleted unless they are removed from the multi-batch. However, you can edit the multi-batch itself. To remove a batch from a multibatch, click a well in the plate layout, and click Remove. To save a multi-batch: 1. Create a new multi-batch. 2.
Running a Batch To run a batch, click Run Batch to open the Batches page. Select the pending batch that you want to run, then click Run. NOTE: If the batch spans more than one plate, the tray ejects automatically when all defined wells have been acquired. A dialog box displays prompting you to insert the next plate. Importing a Batch You only need to import batches to the system once. You must type lot information for the standard and control reagents as specified in the protocol.
1. Open the Batches page. 2. In the Pending Batches section, click the batch you want to delete, then click Delete. The Delete Pending Batch dialog box opens. 3. Click Yes. NOTE: Batches saved to a multi-batch cannot be edited or deleted unless they are removed from the multi-batch. However, you can edit the multi-batch itself. To remove a batch from a multi-batch, click a well in the plate layout, then click Remove. NOTE: To delete a partial batch, open the Admin page, then click the Archive tab.
FIGURE 24. Settings Tab This tab contains the following: Name and description boxes - Type the name and description in the appropriate box. Acquisition Settings: • Volume - This is the volume the instrument will aspirate into the system for analysis. • XY heater - Select to enable the XY heater. In the box type the desired value in degrees Celsius. The temperature range is 35 to 60° C. CAUTION: Acquiring data before the heater has reached the proper temperature can compromise test results.
• Analysis Type - Use this list to choose from the following analysis types: • None - No analysis. Select if you have your own data post-processing program and want to obtain only fluorescent intensity results. You cannot apply standards or controls when you select None. You cannot analyze acquisitions with this setting. • Qualitative - Qualitative analysis determines results as either positive or negative, reactive or non-reactive.
FIGURE 25. Analytes Tab This tab contains the following: Analyte grid - A grid representing each analyte from 1 to 50. Select All selects all analytes, and Deselect All deselects all analytes. Click a numbered analyte to select it; click the analyte again to deselect it. You can also click and drag to select groups of analytes. Selected analytes are red. Deselected analytes are gray. An analyte marked as an intra-well normalization bead is blue.
FIGURE 26. Analysis Settings Dialog Box If you selected Quantitative on the Settings tab, the default analysis formula is 5P Weighted. To change the default, select one of the following from the Method list: • No Analysis • Cubic Spline • Linear Fit • Logistic 4P • Logistic 5P If you selected Logistic 4P or Logistic 5P, select a weight type of either None or 1/y2. . If you selected Qualitative on the Settings tab, the default analysis is Luminex Qualitative.
Apply All - Applies the information in the Units and Counts fields to all analytes. You can also specify the minimum allowable bead count per well that xPONENT analyzes. This excludes data from any beads carried over during acquisition. Selected Analytes List - Selected analytes appear in a list on the right side of the analyte grid. This list includes the following information • Name - The name of the analyte. Click and type to rename the analyte.
FIGURE 27. Protocols Tab This tab contains the following: Batch Name/Description - Used to name and describe a batch. Select a Protocol - Contains the protocol name, version, manufacturer, and creation date for each protocol. Active Reagents - Displays assay and control lots/kits associated with the selected protocol. The Standard/Ctrls Kit Name - Lot# field displays the assay standard/control kit/lot name and lot number currently associated with the selected protocol.
FIGURE 28. Stds & Ctrls Tab This tab contains the following: Apply Std/Ctrl Kit - Opens the Select Std/Ctrl Kit dialog box. The dialog box displays the Std/Ctrl Kit Lot #, Std/Ctrl Kit Name, Expiration, and Manufacturer for the kit. Select a Std/Ctrl kit from the list and then click OK to close the dialog box. The kit information will display in the boxes to the right of the Apply Std/Ctrl Kit button. The selected kit must be associated with the same analyte names.
• Dilution - Contains the following dilution options: • 1:2 - Halves the standard from each previous iteration. • 1:10 (Log) - Computes a value of one-tenth of the standard from each previous iteration. • 1/2 Log - Creates a 1:3.16 dilution, or half of each 1:10 (Log) from each previous iteration. Alternatively, type a number for your own dilution factor. • Apply Dilution - Applies the dilution selected in the Dilution list. NOTE: Click a column header to re-sort the display.
FIGURE 29. Samples Tab This page contains the following tabs: • Create Sample - Displays when the Create New Samples button is clicked. • Edit Samples - Displays when the Details button is clicked. These tabs are numbered because you must complete the steps on each tab sequentially. For example, you must complete the Protocols tab before you can access the Stds & Ctrls tab. WARNING: Human and animal samples may contain biohazardous infectious agents.
Protocol - Displays the protocol selected in the Samples tab. If xPONENT has an LIS license enabled, any sample details provided by the LIS also appear in the Sample List. Version - Displays the version number of the protocol. This cannot be edited. Sample - If you have the LIS-enabled version of the software and are currently connected to the LIS, the sample list autopopulates when the LIS provides sample orders. You can only view or run a sample list created in the LIS; you cannot edit it.
FIGURE 30. Create Sample Tab This tab contains the following: Protocol - Displays the protocol selected in the Samples tab. If xPONENT has a LIS license enabled, any sample details provided by the LIS also appear in the Sample list. Version - Displays the protocol version number. This cannot be edited. Sample - If you have the LIS-enabled version of the software and are currently connected to the LIS, the sample list autopopulates when the LIS provides samples orders.
Save - Saves changes made to the Sample list. Close - Returns to the Samples tab. Creating a New Sample List 1. Open the Samples page. 2. In the Sample Lists section, select the protocol you are using for the sample list, then click Create New Samples. The Create Sample tab opens. 3. In the ID box, type the sample ID. 4. Type a patient first name in the First name box if desired. 5. Type a patient last name in the Last name box if desired. 6.
Current Batch Tab To view the Current Batch tab, click the Results page. The Current Batch tab also displays when you run a batch. Use this tab to view results, statistics, and log information related to the current batch, and to perform statistical analysis on batch results. This tab offers real-time monitoring of batch sampling during acquisition through a display of sample bead statistics and analytes. The statistics available on this tab are intra-well statistics.
Single Step - Allows analysis of one well at a time. Select or clear this check box to turn this function on or off. Scroll Arrows - Use the up, down, left, and right arrow buttons to scroll through the table. Maximize/Minimize - Use this toggle button to maximize and minimize the Plate Image, Dot Plot, and List. Plate - Select a plate from the drop-down list. Save Image - Saves the information displayed on this page as an image file.
• % Recovery - A measure of how accurately your observed results match your expected results following regression analysis. (Observed concentration) / (Expected concentration) x 100% • Expected Result - The known or expected test result value for a standard or control. • Control Range - Low - The lowest value for an assay control used to determine pass/fail criteria for an assay. • Control Range - High - The highest value for an assay control used to determine pass/fail criteria for an assay.
• Maximize - Maximizes the Progress display to fill the window. • Zoom - Enable a closer look at the analyte progress. • Save Image - Opens a Save As dialog box to save a screen capture. • Default - Returns to the dot plot display. Well Report - Displays a representation of the plate and the status of sample acquisition. Wells will display one of three possible states: • Yellow - Well acquired, with a problem (select the Log tab for more information). • Green - Well acquired successfully.
Select Replay Mode To replay a batch, open the Results page, then the Saved Batches tab. Select the batch that you want to replay and click Replay at the bottom of the screen. This opens the Select Replay Mode dialog box. Select Replay batch or Recalculate data as described below. The information that you must enter to replay or recalculate is the same. A batch can be reprocessed multiple times. NOTE: When replaying or recalculating large batches, the operation may take 1 hour or more to complete.
Analyzing a Saved Batch Open the Results page, then open the Saved Batches tab. Select the batch name, then click Open. The Results, Log, and Sample Details tabs appear. • Click the Results tab to view statistical information about the batch. • Click the Log tab to view a log for the activity that occurred during acquisition of the selected batch. • Click the Sample Details tab to view sample details for each sample in the batch.
FIGURE 34. Filter Setup Dialog Box This dialog box lets you choose the saved batch that you want to display in the Completed Batches list, based on the options you select or clear in the following check boxes: • Batch Name • Protocol • Batch Status • Lot ID • Kit ID • Analyte • Sample ID • First Name • Last Name • User ID • Date Reset - Clears all check boxes. OK - Closes the dialog box and applies any changes you made. Cancel - Closes the dialog box and cancels any changes you made.
Import - Opens the Open dialog box to choose a batch file (.mdf) to import. Select Include Raw Files (LXB) to import the raw data file as well. Export - Opens the Export Batch dialog box to choose a destination for the batch file (.mdf). Select Include Raw Files (LXB) to include the raw file in the export. Select Overwrite to overwrite pre-existing files. Open - Opens the Results tab. Use this tab to view the saved batch results for the selected batch.
Results Page Once data is collected in a batch, observation and analysis take place in the Results page. This page contains the following tabs: • Current Batch tab • Saved Batches tab • Results tab • Log tab • Sample Details tab • LIS Results tab • Reports tab The information that you can view and the actions you can perform differ depending on which of these tabs you click. Results Tab Access this tab by clicking the Results page, then Saved Batches. The Results tab opens.
FIGURE 35. Results Tab This tab displays the following: • Results • Statistic • Analyte • Displayed Well • Well information (Well, Sample, Run Statistic; Analytes by number) • Plate Layout image. Confirm that the plate layout conforms to your specific assay instructions. • Bead Map The Results tab has the same Save Image and Progress buttons as the Current Batch tab.
• Validate - Validates an entire selected row or cell in the Results table. Average rows or cells cannot be selected. If you haven’t selected an item or the item you selected does not need to be validated, a warning dialog box displays. Your xPONENT system administrator must give you privileges to invalidate standards if you are using the Secure xPONENT package. • Invalidate - Invalidates an entire selected row or cell in the Results table. The selection will turn red when invalidated.
FIGURE 36. Settings Tab Name and description boxes - Type the name and description in the appropriate box. Acquisition Settings: • Volume - This is the volume the instrument will aspirate into the system for analysis. Type the desired sample volume in microliters. Use values from 10 to 200 µl. To avoid air intake, add at least 25 µl to the sample well in addition to the sample size. The default value is 50 µl. • XY heater - Select Enabled to enable the XY heater.
Analysis Settings - Use this section to set the analysis type, set the number of standards and controls, select an external analysis program, and choose whether to analyze results while acquiring samples. Analysis Type - Use this list to choose from the following analysis types: • None - No analysis. Select if you have your own data post-processing program and want to obtain only fluorescent intensity results. You cannot apply standards or controls when you select None.
• Fit of all Standards - The standard curve will be determined by using each individual standard replicate when calculating the standard curve. For example, if you run duplicates of a seven-point standard curve, the software will calculate the standard curve by using 14 points. Applies only to quantitative analysis. • Mean of Replicates - The standard curve will be determined by averaging the individual standard replicates when calculating the standard curve.
• Date • Message • Code Log entries are displayed in yellow if a well was acquired with a warning. Log entries are displayed in red if a problem occurred during acquisition. Print - Prints the log. Export - Opens the Save As dialog box so that you can save the log file. Browse to a location and click Save. Close - Reopens the Saved Batches tab. Sample Details Tab Use this tab to view sample results. FIGURE 38. Sample Details Tab Arrows - Scroll through the sample details.
LIS Results Tab This tab displays saved batches containing LIS samples. FIGURE 39. LIS Results Tab Filter- Opens the Filter Setup dialog box. Clear - Click to turn off the filter. Completed Samples - Displays Name, Protocol, Sample Count, Date, Status, and User information for each batch displayed in this list. Transmit - Transmits a batch to a LIS if a licensed version of xPONENT is connected to one. Details - Opens the Sample Details tab to view sample results. To transmit a batch to an LIS: 1.
Reports Tab Use this tab to view, generate, and print reports. xPONENT can format your batch or multibatch results in a variety of export formats and provide different types of information in three different types of reports: • Batch Reports • Protocol Reports • System Log Reports FIGURE 40. Reports Tab Report and Type lists - Choose a report from one of the following categories: Batch Reports - A list of batches appears below the Type list.
• Batch Audit • Patient Report If you choose Data Interpretation, a Select Analytes section appears on the right and displays a list of the analytes in the batch. Select the analytes you want to include in the report. Select All to select all the analytes in the list. Select Clear to clear all the analytes in the list. A series of new buttons appears when you click Generate Report: • Analyte arrows - This feature is directly below the Report list.
Select a system log report, a date from the Date list, and click Generate to generate the report. Advanced Reports - Enables a single option, User Report, in the list. Click Generate to generate the report. NOTE: Install the printer before initiating the Print command. To generate, view, and print a report: 1. Open the Results page, then open the Reports tab. 2. In the Report list, click the report you want to view. 3. In the Type list, select the report type you want to view. 4.
12. In the Count box, type the total desired bead count for each analyte. Click Apply All. 13. To set a bead count and the units for a single analyte, click in the Units and Count columns directly to the right of the analyte grid, and type a units value and bead count. 14. Click in the Call % column and type a value to set an individual analyte’s call percentage. 15. Click Next. The Plate Layout tab opens.
Exporting a Protocol 1. Open the Protocols page, then open the Protocols tab. 2. Select a protocol. 3. Click Export. The Save as dialog box opens. 4. Select a location to export the file to, and click Save. Lots and Kits Assay kits include standards and/or controls. After you enter the assay kit information, it can be used in multiple protocols. However, you should create separate kits specifically for use with each protocol.
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. Alternatively, click Apply Std/Ctrl Kit and select a lot from the Select Lot dialog box. Click OK to apply the lot. 5. If your batch uses controls, select Expected, Low, or High from the Show Value options. Use the Apply Values arrows to apply values down or across the range of analytes. 6. Click Save.
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Chapter 4: Performing System Maintenance Initial Startup When you turn on the system for the first time, perform the following procedures. 1. Adjust the Sample Probe Height 2. Revive After Storage (Luminex) Routine 3. Calibration/Verification Routine Adjusting the Sample Probe Height Adjust the sample probe height to ensure that the probe drops far enough into the well to acquire sample. NOTE: Ensure that there is no liquid in the wells or reservoirs before adjusting the sample probe height. 1.
7. Verify that the reservoir is empty. 8. In the Reservoir section, click well RB1. 9. Verify that the plate is not warped. Warped plates can lead to incorrect probe height adjustment. 10. Place the plate on the plate holder with well A1 in the marked position. 11. Click Retract to retract the plate holder. 12. Type a name for the plate in the Plate Name box. 13. Click Auto Adjust Height. The probe automatically adjusts itself to the locations you selected. 14. Click Eject to eject the plate holder.
FIGURE 41. Sample Probe Height Adjustment 1. Well D6 2. Well D1 3. Well RB1 Revive After Storage Routine After you have adjusted the sample probe height, run the Revive After Storage (Luminex) routine. 1. Open the Maintenance page, then the Cmds & Routines tab. 2. Select Revive After Storage (Luminex) from the drop-down list.
FIGURE 42. Revive After Storate (Luminex) Routine Calibration/Verification Routine 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. Open the Home page. 2. On the Home page, click System Initialization under Daily Activities. The Auto Maint tab opens. 3. Select the Calibration/Verification option. 4.
8. Click Eject on the status bar. NOTE: To ensure that you get the necessary bead count, invert the calibrator and verifier vials perpendicular to the plate as you add drops to the wells. This ensures that the maximum fluid drop size is dispensed into the wells. 9. Click Retract. 10. Click Run. Daily Activities For ease of use, define your system initialization routine to use the option for Fluidics prep, performance verification.
3. Verify that kits have been activated and that the correct reagents (VER and Fluidics reagents) have been added to the off-plate reagent block. 4. Add alcohol to the off-plate reagent block according to the off-plate reagent image in the Reagents section. 5. Verify that there is room in the Rinse well for the liquid volume that will be expelled into the well. 6. Click Run. FIGURE 44.
• System Shutdown- Use this routine to perform a pre-defined system shutdown. • Alcohol Flush- Use this routine to run a single alcohol flush. • Sanitize- Use this routine to run a sanitize command. The commands for these routines display in the command list below the buttons. FIGURE 45. Auto Maint Tab Command - Displays the name of the current command, its well location, its status, and information about the command. Only the current commands appear in the box.
Lot Management Tab Use this tab to import, export, delete, or create new calibration and verification lot information. You can also activate reagents by selecting the kit or lot number. FIGURE 46. Lot Management Tab Active Reagents - Use this section to change calibration or performance verification kits, lot numbers, and expiration dates, or to delete a kit. • Calibration Kit - Select a calibration kit from this list.
• Expiration - Displays the expiration date for the lot type selected in the Active section to the left. • Calibrator - If a calibration reagent is selected, the Lot Details table displays Channel and Target information. • Verifier - If a verification reagent is selected, the Lot Details table displays target information. Drive Fluid Level The Drive Fluid liquid level sensor warns you when there is enough Drive Fluid in the container to run one plate or less.
FIGURE 47. Cmds and Routines Tab Routine Name - This list of pre-set routines and commands can be used for system maintenance. Some of these commands are also available on the Auto Maint tab. Additionally, you can create routines on this tab, which display in the Routine Name list once you save the routine. To create a routine, start with None and add the desired commands. You can also modify a Luminex routine and save it as a new routine.
Plate Name - The name assigned to the plate. CAUTION: If using multiple plates users must be careful to ensure that plates are used in the proper order. Failure to do so can result in inaccurate data and test results. Commands - This section contains the following commands: • Wash - Sends 250µl distilled water through the chamber and fluidic lines in the system. It pulls the fluid from a well or from the reservoir and runs it completely through the system to the waste receptacle.
Clean - The probe aspirates 100µl of a cleaning reagent from any well or off-plate reservoir, and dispenses the reagent into the chamber. (Luminex recommends using alcohol as your cleaning reagent, but sodium hydroxide can also be used.) The cleaning reagent then sits in the chamber for 5 minutes, after which the system flushes Drive Fluid through the chamber to completely replace any leftover cleaning fluid in the line, chamber, or probe.
4. In the Commands section, click one or more commands to add to the routine. These commands display in the plate image and in the Command Sequence list. NOTE: When you choose the CAL command, a Rinse command is performed prior to the CAL. When the CAL is complete, two additional Rinse commands are performed. This prevents a bubble from loading into the chamber. Verify that you have sufficient room in the reservoir to complete these Rinse commands.
3. Add, delete, or change commands as necessary, then click Save As. NOTE: When you choose the CAL command, a Rinse command is performed prior to the CAL. When the CAL is complete, two additional Rinse commands are performed. This prevents a bubble from loading into the chamber. Verify that you have sufficient room in the reservoir to complete these Rinse commands. When you choose the VER command, a Rinse command is performed prior to the VER.
Exporting a Routine 1. Open the Maintenance page, then open the Cmds & Routines tab. 2. Click Export. 3. In the Save As dialog box, navigate to the folder where you want to store the routine file, then click Save. NOTE: The export option is only available for routines that have been saved. Probe and Heater Tab Use this tab to adjust the sample probe height and plate heater settings. FIGURE 48.
Plate Location - Defines the location used to auto adjust the probe height. Select the check box for either the main plate, reservoir, and/or strip wells. The plate height must be saved for each different type of 96-well plate; however, the probe height for the reservoir and strip-wells is automatically saved after adjustment. Move Probe Down - Moves the probe down in the specified well(s) Plate Name - Type a name for a plate for future use, or select an existing plate from the list.
FIGURE 49.
• Drive Fluid • Waste Fluid Items in this list relating to calibration and verification have one of the following states: • Passed - Indicates that the process completed successfully. • Failed - Indicates that the process was not completed successfully. Failed items appear in red. • Not Current - Indicates that verifiers are not current. Verifiers are not current if you have calibrated the system since the last time you ran the controls.
FIGURE 50. System Status Tab This tab contains the following: Search By Log Type - Filters the type of log information. Select All, Maintenance, Security, or Warnings and Errors. Search By Log Date - Enables using a date range to display a log of system activities. Advanced - Displays the following added information in the system log: • Log Type • User ID • Error Level Log - Displays a list of information about each system process.
Save - Click to open the Save As dialog box. This saves the file as a PDF. Pick a file name and location to save the file, and click Save. Support Utility Tab Use this tab to create a support file you can send to Luminex Technical Support. FIGURE 51. Support Utility Tab Sending a Support File 1. Type your name in the Name box. 2. Type your company name in the Company box. 3. Type your phone number in the Phone box. 4. Type your e-mail address in the Email box. 5.
7. Verify the location where you want to store the file. To change the location, click Browse, then navigate to the new folder and click OK. 8. Click Export. 9. Send an email to support@luminexcorp.com and attach the support file (xPONENTSupportFile.zip) to the email. Shutting Down the Analyzer Run the daily shutdown routine to prevent clogs and crystallization of salt in the sample probe.
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Glossary 21CFRPart11 21 CFR Part 11 sets the criteria under which the Food and Drug Administration (FDA) considers electronic records, electronic signatures, and handwritten signatures executed to electronic records to be trustworthy, reliable, and generally equivalent to paper records and handwritten signatures executed on paper. agglutination The coalescing of small particles that are suspended in solution; these larger masses are then (usually) precipitated.
CL2 Refers to dyes embedded in the microsphere. Also see classification channel. classification channel A specific range of wavelengths in which light intensity is measured. Includes the fluorescence emission of a given classification dye. Classification channels are abbreviated as CL1 and CL2. CSV Comma separated value file format used to output data from the application. data reduction The analysis of acquired batch data.
MagPlex microspheres Carboxylated spheres with a diameter in the micrometer range. Also called beads. median fluorescence intensity (MFI) Used to denote how much fluorescence a given particle population carries; expressed and compared in linear numbers. microparticle A solid substance with a diameter in the micrometer range. Often used as a synonym for a microsphere. multi-analyte Several assays or tests performed simultaneously in the same reaction container.
RP1 Refers to the dyes bound to the surface of the xMAP microsphere. Also see reporter channel. sample The mixture of assay components (microspheres, reporter, patient dilutant) that is analyzed. sample probe The probe, or needle, on the Luminex analyzer that acquires sample from the 96-well plate. sample reaction The reaction that occurs between reagents and beads. signal Detectable measurement unit of the reporter molecule.
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