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Hygiena BAX System X5 User Manual

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Summary of Contents for Hygiena BAX System X5

  • Page 1 User Guide...
  • Page 2 Information in this document is subject to change without notice. Hygiena assumes no responsibility for any errors that may appear in this document. This document is believed to be complete and accurate at the time of publication. In no event shall Hygiena be liable for incidental, special, multiple, or consequential damages in connection with or arising from the use of this document.

  • Page 3: Table Of Contents

    CONTENTS Introduction and Overview ............................1 About the BAX® System ............................1 User Assumptions ..............................2 Text Conventions ..............................2 Ordering Information ............................... 3 Other Required Equipment and Supplies ........................ 4 Storage and Disposal Information ........................... 5 Shipping Instructions ............................... 6 Technical Assistance ..............................
  • Page 4 Troubleshooting Indeterminate or Error Results ....................555 Troubleshooting Process Interruptions ....................... 577...

  • Page 5: Introduction And Overview

    Introduction and Overview ® About the BAX System ® The BAX System is an automated molecular detection method for identifying foodborne pathogens, spoilage organisms and other microbes in raw ingredients, finished products and environmental samples. For more than 20 years, food companies, service labs and government regulators around the world have relied on the BAX® System to help them get products to market faster while protecting both quality and reputation.

  • Page 6: User Assumptions

    Introduction and Overview User Assumptions • Users are qualified lab personnel who follow good microbiology laboratory practices, including the safe handling and disposal of potentially pathogenic materials. • Users are familiar with Microsoft® Windows® operating system, including navigation and backup procedures.

  • Page 7: Ordering Information

    For more information about the BAX® System and other products from Qualicon Diagnostics, contact your local representative or visit www.hygiena.com. Note: The BAX® System X5 instrument is designed for use with BAX® System X5 assays and associated materials only. BAX®...

  • Page 8: Other Required Equipment And Supplies

    Other Required Equipment and Supplies In addition to the BAX® System X5 instrument, start-up package, and PCR assays, the following items are required to use the BAX® System method. These items are not supplied by Hygiena. • Stomacher capable of homogenizing samples between 200-260 rpm (or equivalent) •...

  • Page 9: Storage And Disposal Information

    Introduction and Overview Storage and Disposal Information Equipment Storage • Clean and maintain required equipment according to the instructions of the manufacturer. • Cooling blocks should be kept refrigerated at 2-8°C and used within 30 minutes of removal from refrigerator. •...

  • Page 10: Shipping Instructions

    Introduction and Overview Shipping Instructions In the event your BAX® System X5 instrument requires service, contact Hygiena or your local distributor to obtain a return authorization number and instructions for returning the unit: • Thoroughly clean the unit of any biohazardous substances.

  • Page 11: The Bax® System X5 Instrument

    I. The BAX® System X5 Instrument Instrument Specifications Item Specification Dimensions (width × depth × height) 9.45 in × 10.63 in × 9.06 in (24 cm × 27 cm × 23 cm) 15.4 lbs (7 kg) Weight 100-240 VAC; 50-60 Hz Power supply Power usage Operates at 24 V with 6.25 A;...

  • Page 12: Instrument Components

    Chapter I - The BAX® System X5 Instrument Instrument Components Instrument Lid The lid of the BAX® System X5 instrument shows different colors based on the status of the instrument: When instrument is not processing samples Color Instrument Status Blue (pulsing) The instrument is powering on.

  • Page 13: Safety Precautions

    Safety Precautions Instrument Safety WARNING - PHYSICAL INJURY HAZARD. Use this instrument as specified by Hygiena to avoid personal injury or damage to the instrument DANGER - ELECTRICAL HAZARD. Use properly configured and approved line cords for the voltage supply in your facility.
  • Page 14 Reagents used with the BAX® System assays should pose no hazards when used as directed. Before using this product, please review the Safety Data Sheets (SDS), available on the web at www.Hygiena.com. Refer to your site practices for safe handling of materials at extreme temperatures.

  • Page 15: Instrument Installation

    Chapter I – The BAX® System X5 Instrument Instrument Installation Review the Environmental Parameters, Instrument Specifications and Safety Precautions in this User Guide before installing the BAX® System X5 instrument. Review the laboratory space intended for the BAX® System X5 instrument and confirm that the appropriate space requirements are met (see “Environmental Parameters”...
  • Page 16 Chapter I - The BAX® System X5 Instrument Note: In some cases, the BAX® System X5 software may detect that the instrument does not have the latest firmware version. If a newer firmware version is available, the dialog box will display a message above the OK button that recommends updating instrument firmware version.

  • Page 17: Instrument Maintenance

    Chapter I – The BAX® System X5 Instrument Instrument Maintenance The BAX® System X5 instrument does not require any regular maintenance procedures. If desired, basic cleaning and upkeep can be performed by following the instructions below. Check the area around the BAX® System X5 instrument to ensure that the air flow is unrestricted. Cleaning the Instrument Casing Remove dust and debris by wiping the instrument surfaces with a lint-free cloth.
  • Page 18 Chapter I - The BAX® System X5 Instrument Decontaminating the Instrument Mount and Exterior Surfaces Dilute a commercially available 5% bleach solution with pure water to create a 1% sodium hypochlorite solution. Wipe the exterior surfaces of the BAX® System X5 instrument and the mount with a cloth dampened – but not dripping wet –...

  • Page 19: Capping/Decapping Tools

    Chapter I – The BAX® System X5 Instrument Capping/Decapping Tools With your purchase of the BAX® System X5 start-up package, you receive a tool* that facilitates the decapping and resealing of the PCR tubes. This tool allows you to easily remove the domed caps from a strip of up to eight PCR tubes at once without jarring the contents of the tubes (A).

  • Page 21: The Bax® System X5 Software

    II. The BAX® System X5 Software The BAX® System X5 Software Window The main window is divided into these sections: The Menu Bar provides drop-down options for performing software functions and otherwise manipulating the file. File Menu View Menu Tools Menu Help Menu BAX®...
  • Page 22 Chapter II – The BAX® System X5 Software The View Tabs switch between Rack View and Table View of the sample setup and results. Rack View Tab Detail View Tab The Operation Tabs switch between viewing Well Info for a specific sample, Rack Info for the entire process run and Instrument status.

  • Page 23: Creating A Rack File

    Chapter II – The BAX® System X5 Software The Graph Tabs switch between viewing the Well Chart (graph of the results for a specific sample) or the Temperature Profile (graph of the heating/cooling cycles during a process run) After the process run is complete, the Well Chart displays a During a process run, the Temperature Profile tab displays a graphical representation of the sample results.

  • Page 24: Printing Reports

    Chapter II – The BAX® System X5 Software Printing Reports To print the results from a BAX® System X5 process run, select FILE > PRINT from the software Menu Bar. Results can be printed in five standard formats: Rack Report – Prints a one-page summary of all samples in a process run, including the yes-or-no well results icons for each sample Detailed Report –...
  • Page 25 Chapter II – The BAX® System X5 Software Overlay Well Report – Prints a one-page report for multiple wells, overlaying the graphs for comparison. Grpahical Report – Prints all selected wells in small individual graphs for comparison. BAX® System X5 User Guide...

  • Page 26: Installing And Upgrading The Bax® System Software

    Chapter II – The BAX® System X5 Software Installing and Upgrading the BAX® System Software Because each release of BAX® System software builds on improvements from previous versions, it is strongly recommended that you always install the most recent version as soon as possible for optimal performance. Note: The BAX®...
  • Page 27 Chapter II – The BAX® System X5 Software Re-start the BAX® System X5 computer to complete the software install and apply all changes. Click YES to re-start the computer immediately after the software install is complete, or click NO to re-start the computer at a later time.

  • Page 28: The Bax® System X5 Pcr Assays

    BAX® System instrument. Assay Validation The protocols in this chapter have been validated by Hygiena for use with the BAX® System assays. In order to follow the BAX® System method, the enrichment and sample preparation protocols must be followed exactly as described in this user guide and the kit instructions.

  • Page 29: Using The E. Coli O157:H7 Assay

    Chapter III. The BAX® System X5 PCR Assays Using the E. coli O157:H7 Assay Kit #KIT2022 (D15407214) 1. Enrich Samples AOAC Research Institute has validated the BAX® System for detecting E. coli O157:H7 in raw ground beef, beef trim, spinach and lettuce. This test kit’s performance was reviewed by AOAC Research Institute and was found to perform to the manufacturer’s specifications.
  • Page 30 Chapter III. The BAX® System X5 PCR Assays French Association of Normalization (AFNOR Certification) has certified the BAX® System MP assay according to the NF VALIDATION rules for detecting E. coli O157:H7 in raw beef, raw pork, lamb, chicken, raw milk and cooked fruits and vegetables.
  • Page 31 Chapter III. The BAX® System X5 PCR Assays 2. Prepare BAX® System Lysis Reagent Note: Do not over-mix the lysis reagent, as this can cause the mixture to foam. To create a full bottle of BAX® System lysis reagent (prepares about 60 samples) Add 150 μL of protease to one 12-mL bottle of lysis buffer.
  • Page 32 Chapter III. The BAX® System X5 PCR Assays Transfer 50 μL lysate into PCR tubes, then seal with flat optical caps. Repeat with remaining strips of PCR tubes until all PCR tablets have been hydrated and sealed. 5. Complete a BAX® System Process Run Take the rack of PCR tubes in the cooling block to the BAX®...
  • Page 33 Chapter III. The BAX® System X5 PCR Assays Close the instrument lid as soon as possible to prevent the instrument from cooling. The process run begins automatically. Note: After the instrument lid is closed, it may take a few moments for the instrument to stabilize before the run begins.
  • Page 34 Chapter III. The BAX® System X5 PCR Assays Positive E. coli O157:H7 MP Melting Curve Profiles Samples that are positive for E. coli O157:H7 will display two target peaks. These target peaks usually appear between 81-90°C. The graph also displays one INPC, or control peak, which usually appears between 79-82°C. If a sample displays a strong positive result, the INPC may be very small in comparison to the target peaks.

  • Page 35: Using The Genus Listeria Assay

    Chapter III. The BAX® System X5 PCR Assays Using the Genus Listeria Assay Kit #KIT2024 (D15407193) 1. Enrich Samples AOAC Research Institute has validated the BAX® System for detecting Genus Listeria on environmental surfaces (stainless steel, plastic, ceramic tile, rubber, painted and unpainted wood, drain swabs, sealed concrete, cast iron, and air filter material) and on foods (dairy, meat, fish and vegetables).
  • Page 36 Chapter III. The BAX® System X5 PCR Assays Cheese Homogenize 25 g samples with 225 mL pre- Transfer 100 µL enriched warmed (30°C) Demi-Fraser broth. Incubate at sample to 9.9 mL pre-warmed 30°C for 22-26 hours. (35°C) MOPS-BLEB. Incubate at 35°C for 18-24 hours. Queso Fresco Homogenize 25 g samples with 225 mL of pre- Transfer 100 µL enriched...
  • Page 37 Chapter III. The BAX® System X5 PCR Assays 4. Hydrate PCR Tablets Select a chilled (2-8°C) PCR cooling block. Note: Remember that you must finish using the cooling block within 30 minutes. Place a 32-well PCR tube rack over the insert. Arrange strips of PCR tubes according to your rack file.
  • Page 38 Chapter III. The BAX® System X5 PCR Assays To process fewer than 32 samples, load samples first in Row A and Row D, starting at the corners. Once the two outer rows are full, then use Row B and Row C to load samples in a symmetric pattern to ensure the instrument mount remains balanced.
  • Page 39 Chapter III. The BAX® System X5 PCR Assays 6. Review Results Note: For more information about reading BAX® System results, see “Reviewing BAX® System Results”. When processing in the BAX® System X5 instrument is complete, a new window appears showing each color-cued well with an icon in the center to illustrate the result: Indeterminate Green (-)
  • Page 40 Chapter III. The BAX® System X5 PCR Assays Negative Genus Listeria Melting Curve Profile Samples that are negative for Listeria species will display no target peaks. The graph displays only the INPC, or control peak, which usually appears between 76-81°C. Example of Typical Melt Curve for Negative Genus Listeria Sample 7.
  • Page 41 Chapter III. The BAX® System X5 PCR Assays Using the Listeria monocytogenes Assay Kit #KIT2023 (D15407201) 1. Enrich Samples AOAC Research Institute has validated the BAX® System for detecting Listeria monocytogenes in a wide variety of foods, including raw meats, fresh produce/vegetables, processed meats, seafood, dairy cultured/non-cultured, egg and egg products and fruit juices and plastic surfaces.
  • Page 42 Chapter III. The BAX® System X5 PCR Assays 2. Prepare BAX® System Lysis Reagent Note: Do not over-mix the lysis reagent, as this can cause the mixture to foam. To create a full bottle of BAX® System lysis reagent (prepares about 60 samples) Add 150 μL of protease to one 12-mL bottle of lysis buffer.
  • Page 43 Chapter III. The BAX® System X5 PCR Assays 4. Hydrate PCR Tablets Select a chilled (2-8°C) PCR cooling block. Note: Remember that you must finish using the cooling block within 30 minutes. Place a 32-well PCR tube rack over the insert. Arrange strips of PCR tubes according to your rack file.
  • Page 44 Chapter III. The BAX® System X5 PCR Assays To process fewer than 32 samples, load samples first in Row A and Row D, starting at the corners. Once the two outer rows are full, then use Row B and Row C to load samples in a symmetric pattern to ensure the instrument mount remains balanced.
  • Page 45 Chapter III. The BAX® System X5 PCR Assays 6. Review Results “ Note: For more information about reading BAX® System results, see Reviewing BAX® System Results”. When processing in the BAX® System X5 instrument is complete, a new window appears showing each color-cued well with an icon in the center to illustrate the result: Indeterminate Green (-)
  • Page 46 Chapter III. The BAX® System X5 PCR Assays 7. Confirm Positive Results Method approved by AOAC Positive results can be confirmed according to the AOAC confirmation method by following the reference culture method appropriate for the sample type. To confirm results with the FDA-BAM method, see the protocol described in the Bacteriological Analytical Manual.

  • Page 47: Using The Salmonella Assay

    Chapter III. The BAX® System X5 PCR Assays Using the Salmonella Assay Kit #KIT2025 (D15407187) 1. Enrich Samples AOAC Research Institute has validated the BAX® System for detecting Salmonella in meat, poultry, fruit and vegetable products, dairy products, chocolate/bakery products, pasta, dry pet food and environmentals.
  • Page 48 Chapter III. The BAX® System X5 PCR Assays Transfer 10 μL enriched Custard, 2% milk, Homogenize 25 g sample with 225 mL pre-warmed sample to 500 μL pre- chilled ready meal, (35°C) LB. Let stand at room temperature for 55-65 cooked fish, prawns, minutes.
  • Page 49 Chapter III. The BAX® System X5 PCR Assays Raw beef (including Homogenize 25 g sample in 225 mL pre-warmed None seasoned and (42°C) BAX® System MP media. Incubate at 42°C for frozen) in MP media 9-24 hours. Other raw meat Homogenize 25 g sample in 225 mL pre-warmed None (42°C) BAX®...
  • Page 50 Chapter III. The BAX® System X5 PCR Assays 4. Hydrate PCR Tablets Select a chilled (2-8°C) PCR cooling block. Note: Remember that you must finish using the cooling block within 30 minutes. Place a 32-well PCR tube rack over the insert. Arrange strips of PCR tubes according to your rack file.
  • Page 51 Chapter III. The BAX® System X5 PCR Assays To process fewer than 32 samples, load samples first in Row A and Row D, starting at the corners. Once the two outer rows are full, then use Row B and Row C to load samples in a symmetric pattern to ensure the instrument mount remains balanced.
  • Page 52 Chapter III. The BAX® System X5 PCR Assays 6. Review Results Note: For more information about reading BAX® System results, see “Reviewing BAX® System Results”. When processing in the BAX® System X5 instrument is complete, a new window appears showing each color-cued well with an icon in the center to illustrate the result: Indeterminate Green (-)
  • Page 53 Chapter III. The BAX® System X5 PCR Assays Negative Salmonella Melting Curve Profile Samples that are negative for Salmonella will display no target peaks. The graph displays only the INPC, or control peak, which usually appears between 76-80°C. Example of Typical Melt Curve for Negative Salmonella Sample 7.

  • Page 54: Reviewing Bax® System Results

    Chapter III. The BAX® System X5 PCR Assays Reviewing BAX® System Results After you click on the SAMPLES UNLOADED button, a new window displays a modified rack view. BAX® System results are displayed as clear “yes” or “no” icons that do not require expert interpretation. Each well now appears in different colors with a symbol in the center to illustrate the result.
  • Page 55 Chapter III. The BAX® System X5 PCR Assays Reviewing Results Graphs Well Chart Target peaks – Positive reactions show target peaks within a specified temperature range. Peaks can shift within their temperature range. In strong positive reactions, the peaks can shift to slightly lower temperatures, and in weaker reactions, the positives can shift to higher temperatures.

  • Page 56: Best Practices For Sample Enrichment And Preparation

    (up to 48 hours). Storing primary enrichments before regrowth is not recommended. For confirmation purposes only, primary enrichments (before regrowth) could be stored at 2-8°C overnight or according to your laboratory SOP. However, these storage conditions have not been validated by Hygiena. Tips for Transferring Samples •...
  • Page 57 Chapter III. The BAX® System X5 PCR Assays • When transferring samples, begin and complete one column at a time as shown in the BAX® System Ready Reference. Cap tubes after finishing a single row of samples to avoid cross-contamination. •...

  • Page 58: Using Analog Heating And Cooling Blocks With The Bax® System Assays

    Chapter III. The BAX® System X5 PCR Assays Using Analog Heating and Cooling Blocks with the BAX® System Assays If you do not wish to use the Automated Thermal Block for automated sample lysis, the lysis steps for the BAX® System method may also be performed using separate analog heating and cooling blocks.

  • Page 59: Iv. Troubleshooting The Bax® System

    The troubleshooting tips provided in this chapter are intended to provide general guidance for the most common customer issues with the BAX® System X5 instrument and procedures. For additional technical assistance, contact Hygiena Diagnostics Support or your local distributor. Accessing Log Files Diagnostics Support may request log files during troubleshooting.
  • Page 60 Chapter IV. Troubleshooting the BAX® System Air Bubbles in PCR Tubes What It Looks Like – There appears to be no reaction within the sample data. Note: In many cases, samples with air bubbles may not display indeterminate results; however, the signal peaks are shifted away from the expected temperature range or appear as “weak”...
  • Page 61 Detection Only operation. This option allows you to re-analyze samples that have already begun the detection phase of the standard full process. Results are available after about 1 hour. Do not use the Detection Only process unless instructed to do so by Hygiena Diagnostics Support or your local Hygiena representative or distributor.
  • Page 62 Chapter IV. Troubleshooting the BAX® System The Detection Only process begins with an initial hold step, followed by a melt step. As the run progresses, the Instrument tab displays a status bar and estimates the time remaining before results can be viewed. During the process, the instrument temperature is displayed graphically in the Graph Tab labeled “Temperature Profile”.
  • Page 63 Equipment or refund the purchase price; (b) Should BAX® System software fail to conform with the Paragraph 3 warranty, Hygiena will replace it free of charge; (c) For all other claims, Hygiena may, at its option, refund the purchase price or replace the Equipment, assays or media; (d) In all cases, user is responsible for the repackaging and return of non-conforming Equipment, along with the reinstallation of new or refurbished Equipment;...
  • Page 64 4.Transfer: This Agreement is not assignable or transferable, in whole or in part, except with the written consent of Hygiena. 5.Limitation of Liability. Hygiena warrants that for a period of 60 days from the date of first date of use by the Customer, BAX® System software will be free from defect in materials and workmanship and that the BAX®...

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