1. Manuals
  2. Brands
  3. Qiagen Manuals
  4. Laboratory Equipment
  5. Rotor-Gene Q MDx CE
  6. User manual

Qiagen Rotor-Gene Q MDx CE User Manual

Hide thumbs
Table of Contents

Advertisement

Quick Links

Download this manual
Rotor-Gene
Manual
9002022, 9002032, 9002042
QIAGEN GmbH
QIAGEN Strasse 1, 40724 Hilden, GERMANY
R1
Sample to
Insight__
Q MDx CE User
®
February 2022

Advertisement

Table of Contents

Troubleshooting

loading
Need help?

Need help?

Do you have a question about the Rotor-Gene Q MDx CE and is the answer not in the manual?

Questions and answers

Subscribe to Our Youtube Channel

Related Manuals for Qiagen Rotor-Gene Q MDx CE

Summary of Contents for Qiagen Rotor-Gene Q MDx CE

  • Page 1 February 2022 Rotor-Gene Q MDx CE User ® Manual 9002022, 9002032, 9002042 QIAGEN GmbH QIAGEN Strasse 1, 40724 Hilden, GERMANY Sample to Insight__...

  • Page 2: Table Of Contents

    Optical system ..................23 3.1.3 Available channels ................24 External features of the Rotor-Gene Q MDx .............25 3.2.1 Air vents on the lid ................25 3.2.2 Lid handle ...................25 3.2.3 Rotor chamber ..................25 3.2.4 Instrument status lights ................25 Rotor-Gene Q MDx CE User Manual 02/2022...
  • Page 3 Powering ON the Rotor-Gene Q MDx and workstation ......44 Operating Procedures .....................45 Use of the Rotor-Gene Q MDx software ............45 5.1.1 Quick Start wizard ................45 5.1.2 Advanced wizard .................49 Use of the Rotor-Gene Q MDx hardware ............67 5.2.1 Rotor types ..................67 Rotor-Gene Q MDx CE User Manual 02/2022...
  • Page 4 6.6.10 Concentration analysis ................117 6.6.11 High Resolution Melt analysis ...............120 Run menu ....................121 6.7.1 Start Run ....................121 6.7.2 Pause Run ..................121 6.7.3 Stop Run ....................122 View menu ....................122 6.8.1 Run Settings ..................122 6.8.2 Temperature Graph ................125 Rotor-Gene Q MDx CE User Manual 02/2022...
  • Page 5 Cleaning the Rotor-Gene Q MDx surface ............159 Decontaminating the Rotor-Gene Q MDx surface..........160 Rotor-Gene Q repair ...................160 Optical Temperature Verification ................161 OTV principle ....................161 Rotor-Disc OTV Kit components ..............161 Running an OTV ..................162 High Resolution Melt Analysis ................165 Rotor-Gene Q MDx CE User Manual 02/2022...
  • Page 6 13.5.2 Optical specifications ................192 Appendix A – Legal ....................193 14.1 FCC Declaration ..................193 14.2 IEC EN 61326 Compliance ..............194 14.3 Declaration of Conformity ................195 14.4 Waste Electrical and Electronic Equipment (WEEE) ........196 14.5 Liability Clause ..................197 Rotor-Gene Q MDx CE User Manual 02/2022...
  • Page 7 15.1 Quantitation ..................201 15.1.1 Confidence intervals for calculated concentrations ........201 15.1.2 Confidence intervals for CT values ............202 Ordering Information ....................203 16.1 Rotor-Gene Q MDx products, accessories, and consumables .......203 Document Revision History ..................206 Rotor-Gene Q MDx CE User Manual 02/2022...

  • Page 8: Introduction

     Installation Procedures  Operating Procedures  Maintenance  Troubleshooting  Technical Specifications  Appendices  The appendices contain the following information: Appendix A – Legal  Appendix B – Mathematical Techniques  Rotor-Gene Q MDx CE User Manual 02/2022...

  • Page 9: General Information

    QIAGEN customers are a major source of information regarding advanced or specialized uses of our products. This information is helpful to other scientists as well as to the researchers at QIAGEN. We therefore encourage you to contact us if you have any suggestions about product performance or new applications and techniques.

  • Page 10: Version Management

    (PCR) in clinical applications. The Rotor-Gene Q MDx is intended to be used only in combination with QIAGEN kits indicated for use with Rotor-Gene Q instruments for applications described in the respective QIAGEN kit handbooks.

  • Page 11: Materials Required

    Materials required Note: Only use accessories supplied by QIAGEN. Rotor-Gene Q MDx 5Plex (cat. no. 9002020)  Rotor-Gene Q MDx 5Plex HRM (cat. no. 9002030)  Rotor-Gene Q MDx 6Plex (cat. no. 9002040)  Laptop (cat. no. 9026760)  72-Well Rotor (cat. no. 9018903) ...

  • Page 12: Safety Information

    Please be aware that you may be required to consult your local regulations for reporting serious incidents that have occurred in relation to the device to the manufacturer and/or its authorized representative and the regulatory authority in which the user and/or the patient is established. Rotor-Gene Q MDx CE User Manual 02/2022...

  • Page 13: Proper Use

    Servicing of the Rotor-Gene Q MDx instrument must only be performed by a QIAGEN Field Service Specialist. Perform the maintenance as described in Section 8. QIAGEN charges for repairs that are required due to incorrect maintenance. WARNING Risk of personal injury and material damage The Rotor-Gene Q MDx is too heavy to be lifted by one person.
  • Page 14 Damage to the instrument CAUTION Always use a locking ring on the rotor. This stops caps from coming off tubes during an experiment. If caps come off during an experiment, they may damage the chamber. Rotor-Gene Q MDx CE User Manual 02/2022...

  • Page 15: Electrical Safety

    If liquid has spilled inside the instrument, switch off the instrument, disconnect it from the  power outlet, and contact QIAGEN Technical Services. If the instrument becomes electrically unsafe, prevent other personnel from operating it, and contact QIAGEN Technical Services.

  • Page 16: Biological Safety

    Samples Samples may contain infectious agents. You should be aware of the health hazard presented by such agents and should use, store, and dispose of such samples according to the required safety regulations. Rotor-Gene Q MDx CE User Manual 02/2022...

  • Page 17: Chemical Safety

    * OSHA: Occupational Safety and Health Administration (United States of America). ACGIH: American Conference of Government Industrial Hygienists (United States of America). † COSHH: Control of Substances Hazardous to Health (United Kingdom). ‡ Rotor-Gene Q MDx CE User Manual 02/2022...

  • Page 18: Waste Disposal

    Make sure that the rotor and locking ring are installed correctly. If the rotor or locking ring show signs of mechanical damage or corrosion do not use the Rotor-Gene Q MDx; contact QIAGEN Technical Services. Rotor-Gene Q MDx CE User Manual...
  • Page 19 (248°F). Avoid touching it when it is hot. WARNING Hot surface When pausing a run, the Rotor-Gene Q MDx will not be cooled completely to room temperature. Exercise caution before handling the rotor or any tubes in the instrument. Rotor-Gene Q MDx CE User Manual 02/2022...

  • Page 20: Maintenance Safety

    Maintenance safety Perform the maintenance as described in Section 8. QIAGEN charges for repairs that are required due to incorrect maintenance. WARNING Risk of personal injury and material damage /CAUTION Only perform maintenance that is specifically described in this user manual.

  • Page 21: Symbols On The Rotor-Gene Q Mdx

    RCM (former C-Tick) for Australia (supplier identification panel N17965) Type plate on the right side RoHS mark for China (the restriction of the use of certain panel hazardous substances in electrical and electronic equipment) Rotor-Gene Q MDx CE User Manual 02/2022...

  • Page 22: General Description

    General Description The Rotor-Gene Q MDx is an innovative instrument that enables high-precision real-time PCR, and that is highly suited for in vitro diagnostic applications in combination with QIAGEN IVD marked kits. The powerful and user-friendly software provides simplicity for beginners as well as an open experimental platform for advanced users.

  • Page 23: Optical System

    The fixed optical path ensures consistent excitation for every sample, which means that there is no need to use a passive internal reference dye such as ROX™. Rotor-Gene Q MDx CE User Manual 02/2022...

  • Page 24: Available Channels

    , LC Green Plus+, ® ® EvaGreen Note: QIAGEN kits indicated for use with the Rotor-Gene Q MDx instruments are optimized with respect to certain dye combinations. Please refer to the corresponding kit handbooks for more information. Rotor-Gene Q MDx CE User Manual...

  • Page 25: External Features Of The Rotor-Gene Q Mdx

    Instrument status lights There are two status lights on the Rotor-Gene Q. The standby light indicates that the instrument is not in use. The running light flashes when the Rotor-Gene Q is in use. Rotor-Gene Q MDx CE User Manual 02/2022...

  • Page 26: Internal Features Of The Rotor-Gene Q Mdx

    Rotor hub Optical lens 3.3.1 Rotor hub The rotor hub holds the rotor in place within the instrument. 3.3.2 Optical lens Optical lens were the excitation diode light is focused on the tubes. Rotor-Gene Q MDx CE User Manual 02/2022...

  • Page 27: Installation Procedures

    Rotor-Gene Q MDx User Manual  Workstation  Rotor-Gene Q MDx software (will be installed by QIAGEN Field Service during initial set up)  4.1.1 Unpacking the Rotor-Gene Q MDx The Rotor-Gene Q MDx is delivered with all the necessary components for setting up and running the instrument.

  • Page 28: Hardware Installation

    5. Connect the USB cable or RS-232 serial cable supplied to a USB or communications port on the back of the computer. 6. Connect the USB or RS-232 serial cable to the back of the Rotor-Gene Q MDx. Rotor-Gene Q MDx CE User Manual 02/2022...

  • Page 29: Software Installation

    Do not use other cables. 4.1.3 Software installation 1. To install the Rotor-Gene Q software, download the software from QIAGEN.com and transfer to the computer on a virus free removable media or insert the Removable Media (software) delivered with the instrument into the computer.
  • Page 30 Note: When starting connected to a computer for the first time, the Rotor-Gene Q MDx will be recognized by the operating system and a number of messages will appear. Please refer to Rotor-Gene Q Installation Guide provided with the instrument (Removable Media and printed edition) for guidance. Rotor-Gene Q MDx CE User Manual 02/2022...
  • Page 31 If virtual mode was chosen the following message appears: If the Run in Virtual Mode box is unchecked, the software initializes and opens automatically. Exit Program: Clicking on this button exits the program. Rotor-Gene Q MDx CE User Manual 02/2022...

  • Page 32: Software Version

    Antivirus software QIAGEN is aware of the threat that computer viruses cause to any computer that exchanges data with other computers. Rotor-Gene AssayManager version 1.0 or 2.1 software is expected to be primarily installed in environments where local policies are in place to minimize this threat.
  • Page 33 For networked operation, the firewall on the laptop computer provided by QIAGEN is configured in a way that inbound traffic is blocked for all ports except those required to establish a network connection.
  • Page 34 Outgoing connections are allowed because they may be required for retrieving updates. If your configuration is different, QIAGEN recommends configuring the firewall in the same way as described above. To this end, a system administrator must log in and perform the following steps: 1.
  • Page 35 For security and reliability reasons, cable-based network access instead of Wi-Fi shall be used. The laptop computers provided by QIAGEN have a disabled Wi-Fi adapter. If your configuration is different, a system administrator must disable the Wi-Fi adapter manually, by doing the following steps: 1.
  • Page 36 2. Select Change adapter settings. 3. Hover over Wireless Network Connection, press the right mouse button, and select Disable from the context menu. 4. Check that the Wireless Network Connection is disabled. Rotor-Gene Q MDx CE User Manual 02/2022...
  • Page 37 PCR run. Operating system updates The laptop computers provided by QIAGEN are configured such that automatic updates of the operating system are disabled. If your configuration is different, a system administrator must disable any automatic update process of the operating system, by doing the following steps: 1.
  • Page 38 2. Select Change settings. 3. Select Never check for updates. 4. Check that the Important updates option Never check for updates is active. Rotor-Gene Q MDx CE User Manual 02/2022...

  • Page 39: Site Requirements

    In the event that updates are required due to uncovered security vulnerabilities, QIAGEN provides mechanisms to install a defined set of validated Windows security patches either online (if internet connection is available on the QIAGEN laptop) or as offline package, prepared on a separate computer with internet connection.

  • Page 40: Ac Power Connection

    AC power outlet. Configuration for Windows security The laptop computers that are provided by QIAGEN for use with your Rotor-Gene Q MDx instrument can have Microsoft Windows 7 or Windows 10 preinstalled and are configured with a standard (nonadministrative) Windows user account and an administrator account.
  • Page 41 Open the Windows Control Panel via the Start menu and select User Accounts > Manage Accounts. 1. Choose Create a new account. 2. Name the account and select Standard User as the account type. Rotor-Gene Q MDx CE User Manual 02/2022...

  • Page 42: Workstation Requirements

    Unpacking and installing the Rotor-Gene Q MDx The Rotor-Gene Q MDx is delivered with all the necessary components for setting up and running the instrument. The box also contains a list of all the components provided. Rotor-Gene Q MDx CE User Manual 02/2022...

  • Page 43: Software Upgrade

    A laptop computer may be included in the packaging, depending on your order details. 4.6.1 Software upgrade Software updates available from QIAGEN site https://www.qiagen.com/products/instruments-and-automation/pcr-instruments/rotor-gene-q-mdx/, which can be accessed also from the Help menu in the software. To download the software, it is necessary to register online. Rotor-Gene Q MDx CE User Manual 02/2022...

  • Page 44: Accessories

    When repackaging the Rotor-Gene Q MDx for shipping, the original packaging materials must be used. If the original packaging materials are not applicable, contact QIAGEN Technical Services. Make sure that the instrument has been properly prepared (see Maintenance) prior to packing and that is poses no biological or chemical hazard.

  • Page 45: Operating Procedures

    Section 3. Damage to the instrument CAUTION Only use QIAGEN flow cells and consumables with the Rotor-Gene Q MDx. Damage caused by use of other types of flow cell or consumable will void your warranty. Risk of material damage...
  • Page 46 After copying a file to this path, the template will appear as an icon in the list. If you would like custom icons for your templates, create a *.ico image with the same file name as the template. Rotor-Gene Q MDx CE User Manual 02/2022...
  • Page 47 Edit Profile window (see Section “Edit Profile”). To initiate a run, click the Start Run button. It is also possible to save the template before starting the run by clicking on Save Template. Rotor-Gene Q MDx CE User Manual 02/2022...
  • Page 48 The run is given a file name that consists of the template used and the date of the run. A serial number (1, 2, etc.) is also included in the file name to allow automatic naming of numerous runs that use the same template on the same day. Rotor-Gene Q MDx CE User Manual 02/2022...

  • Page 49: Advanced Wizard

    The Advanced wizard enables options that are not available in the Quick Start wizard, such as configuration of gain optimization. To use the Advanced wizard, select a template by double-clicking the template name from the list under the Advanced tab of the New Run window. Rotor-Gene Q MDx CE User Manual 02/2022...
  • Page 50 Note: User-defined templates can be added to the template list by copying or saving *.ret files to C:\Program Files\Rotor-Gene Q Software\Templates\. After copying a file to this path, the template will appear as an icon in the list. Rotor-Gene Q MDx CE User Manual 02/2022...
  • Page 51 “1, 2, 3...” is the default option. Most users select this option. “1A, 1B, 1C...” should be selected when samples were loaded in adjacent 0.1 ml Strip Tubes using a multichannel pipet with 8 channels. The “A1, A2, A3...” layout may be selected if appropriate. Rotor-Gene Q MDx CE User Manual 02/2022...
  • Page 52 Edit Profile window appears, enabling alteration of cycling conditions and selection of acquisition channels (Section Edit Profile). After setting up the profile, click the Gain Optimisation... button to bring up the Gain Optimisation window (see page 61). Rotor-Gene Q MDx CE User Manual 02/2022...
  • Page 53 If performing Optical Denature Cycling, a Hold can be used as a calibration step. In this case, a calibration melt is performed before the Hold. By default, this is configured for the first Hold in the run, but may be changed if required. Rotor-Gene Q MDx CE User Manual 02/2022...
  • Page 54 Alternatively, click on the step and use the temperature and time buttons to the left of the graph. Steps can be added or removed from the cycle using the “-“ and “+” buttons at the top right of the graph. Rotor-Gene Q MDx CE User Manual 02/2022...
  • Page 55 Not Acquiring button (if a channel has already been set to acquire at this step, then the acquiring channels are listed here). After clicking the Not Acquiring button, the Acquisition window appears. Rotor-Gene Q MDx CE User Manual 02/2022...
  • Page 56 Same as Previous menu. Melt and hybridisation A Melt is a ramp between 2 temperatures, from a lower to a higher temperature. The permitted temperature range is 35–99°C. Rotor-Gene Q MDx CE User Manual 02/2022...
  • Page 57 To perform this technique, simply place a reference tube of PCR product in tube position 1 of the rotor. The reference tube must also contain a detection chemistry that enables detection of strand dissociation. Rotor-Gene Q MDx CE User Manual 02/2022...
  • Page 58 In the following graph, the raw fluorescence readings and the first derivative have been overlaid. This shows the correspondence between the denature threshold and the melt peak obtained during the calibration. Rotor-Gene Q MDx CE User Manual 02/2022...
  • Page 59 For this reason, the temperature trace may vary for each cycle. 2. Click on the first half of the graph with the Optical Denature symbol . The Calibration Settings information appears on the left of the screen. Rotor-Gene Q MDx CE User Manual 02/2022...
  • Page 60 You can also define a Denature step by introducing a new Hold step. Click on Insert before and select New Hold at Temperature from the menu. The calibration settings will appear. Rotor-Gene Q MDx CE User Manual 02/2022...
  • Page 61 If the gain is too low, the signal will be lost in background noise. If it is too high, all signal will be lost off scale (saturated). The gain range for each channel is –10 to 10, where –10 is the least sensitive and 10 is the most sensitive. Rotor-Gene Q MDx CE User Manual 02/2022...
  • Page 62 3 (see New Run Wizard window 3). The Auto-Gain Optimisation Setup window appears. This window enables optimization by automatically adjusting the gain settings until the readings for all selected channels fall within or below a certain threshold. Rotor-Gene Q MDx CE User Manual 02/2022...
  • Page 63 5 and 10 FI in tube 1. In general, for intercalating dyes a Target Sample Range of 1–3 FI is appropriate, while a range of 5–10 FI is more suitable for probe chemistries. Rotor-Gene Q MDx CE User Manual 02/2022...
  • Page 64 It is used when the background of a sample is unknown and therefore the gain must be determined to ensure the sample signal is sufficient for detection. Rotor-Gene Q MDx CE User Manual 02/2022...
  • Page 65 This window summarizes the run. Check the parameters and if they are correct, click Start Run. You will be prompted for a file name. You can also save the run settings as a template for future runs using the Save Template button. Rotor-Gene Q MDx CE User Manual 02/2022...
  • Page 66 The Finish and Lock Samples button closes the screen and prevents the sample names from being modified. For more information about this and other security features, see “Access Protection for Rotor-Gene Q Software“ (page 133). Rotor-Gene Q MDx CE User Manual 02/2022...

  • Page 67: Use Of The Rotor-Gene Q Mdx Hardware

    Rotor-Gene Q MDx and the reaction in the tube. QIAGEN reserves the right to refuse technical support for problems induced by non-QIAGEN-certified plastic materials on the Rotor-Gene Q MDx instrument.
  • Page 68 The 72-Well Rotor is blue in color. The 72-Well Rotor and 72-Well Rotor Locking Ring are used with Strip Tubes and Caps, 0.1 ml, which can be used for volumes as low as 20 µl. The caps provide a safe and reliable seal. Rotor-Gene Q MDx CE User Manual 02/2022...
  • Page 69 Rotor-Disc 100 wells use 96-well plate labeling conventions, that is, A1–A12 through to H1–H12. The additional 4 reference wells are labeled R1–R4. For more information on the Rotor-Disc 100, see Section 5.2.3. Rotor-Gene Q MDx CE User Manual 02/2022...

  • Page 70: Reaction Setup

    0.2 ml tubes which can be used to set up standard curves. The procedure below describes reaction setup using the 72-Well Rotor. The same procedure can be used for reaction setup using the 36-Well Rotor and appropriate accessories. Rotor-Gene Q MDx CE User Manual 02/2022...
  • Page 71 Samples will not be optimally aligned over the detection system if not placed correctly in the rotor. This could result in a reduction in acquired fluorescence signal and detection sensitivity. A Rotor Holder that enables easy tube loading is provided with the instrument. Rotor-Gene Q MDx CE User Manual 02/2022...
  • Page 72 4. Insert the 72-Well Rotor Locking Ring onto the 72-Well Rotor by pushing the 3 locating pins through the outer holes of the rotor. The Locking Ring ensures that caps remain on tubes during a run. Rotor-Gene Q MDx CE User Manual 02/2022...

  • Page 73: Rotor-Disc Setup

    Note: Once the Rotor-Disc Heat Sealer is ready, it is safe to leave it running constantly. 3. Insert the Rotor-Disc into the Rotor-Disc Loading Block using the position one tab on the Rotor- Disc and the tube guide holes on the Rotor-Disc Loading Block. Rotor-Gene Q MDx CE User Manual 02/2022...
  • Page 74 Ensure that the “SIDE UP” label is positioned at the bottom of the Rotor-Disc Loading Block. The central hole in the film should slide easily over the cylinder of the Rotor-Disc Loading Block and onto the top of the Rotor-Disc. Rotor-Gene Q MDx CE User Manual 02/2022...
  • Page 75 Press down on the blue anodized bar to raise and release the sealing mechanism back to its original position. Important: Do not continue sealing for any longer than indicated by the beep or the Rotor-Disc may deform. Rotor-Gene Q MDx CE User Manual 02/2022...
  • Page 76 12. Remove the Rotor-Disc from the Rotor-Disc Loading Block. 13. Load the Rotor-Disc into the rotor using the position one locator tab s a guide to the correct orientation. Rotor-Gene Q MDx CE User Manual 02/2022...

  • Page 77: Analysis User Interface

    Adjust Scale: To select Adjust Scale, click the right mouse button over the appropriate window. Adjust Scale brings up a window in which a scale can be specified. Rotor-Gene Q MDx CE User Manual 02/2022...

  • Page 78: Toggling Samples

    The scroll bar can be used to display the next group of samples. Note: The number of displayed samples is dynamic, and depends on the space available in the window. Rotor-Gene Q MDx CE User Manual 02/2022...
  • Page 79 Groups are arbitrary collections of samples that allow advanced reporting of statistical results. For example, groups of treated and untreated patient samples can be defined. Groups can be set up in the Edit Samples window. Rotor-Gene Q MDx CE User Manual 02/2022...

  • Page 80: File Menu

    Cancel: This closes this window. Help: This opens the online help. Show This Screen When Software If this box is checked, the New Run window is displayed when the software is started. Opens: Rotor-Gene Q MDx CE User Manual 02/2022...

  • Page 81: Open And Save

    LIMS Export: This saves the analysis in LIMS compatible formats according to the requirements of the user. Please contact QIAGEN Technical Services for more information. Excel Data Sheet…: This exports all the raw channels to an Excel sheet.

  • Page 82: Reports

    * Ruijter, J.M., Ramakers, C., Hoogaars, W.M., Karlen, Y., Bakker, O., van den Hoff, M.J., and Moorman, A.F. (2009) Amplification efficiency: linking baseline and bias in the analysis of quantitative PCR data. Nucleic Acids Res. 37, e45. Rotor-Gene Q MDx CE User Manual 02/2022...

  • Page 83: Setup

    Multiple assays run in the same channel can be analyzed independently, provided they have been set up as separate pages in the Rotor-Gene Q MDx CE User Manual 02/2022...
  • Page 84 Smart Tiling method. Alternatively, select another arrangement method by clicking the arrow next to the Arrange button. Clicking the right mouse button on the name of an analysis also provides additional options. Show: This displays the selected analysis. Hide: This hides the selected analysis. Rotor-Gene Q MDx CE User Manual 02/2022...

  • Page 85: Quantitation

    Blue dots on the curve represent the samples that have been defined as standards and red dots represent the unknown sample data points. Rotor-Gene Q MDx CE User Manual 02/2022...
  • Page 86 “Floating” or “Fixed”. If “Floating”, an optimal equation for the standard curve is calculated each time the threshold is moved in the main window. If “Fixed”, the equation does not change because it has been imported from another run. Rotor-Gene Q MDx CE User Manual 02/2022...
  • Page 87 Reset to change the standard curve type back to “Floating”. A screenshot of the Import Standard Curve window is shown below. Using this window, a standard curve can be imported from another channel analyzed in the current run, or from another run. Rotor-Gene Q MDx CE User Manual 02/2022...
  • Page 88 For most analyses, the default upper and lower bounds are suitable. The range of threshold levels is scanned to obtain the best fit of the standard curve based on the samples that have been defined as standards (i.e., where the R value is closest to 1.0). Rotor-Gene Q MDx CE User Manual 02/2022...
  • Page 89 The average CT of all samples with the same name as this sample. Rep. Ct Std. Dev.: The standard deviation of the CT value of all samples with the same name as this sample. Rotor-Gene Q MDx CE User Manual 02/2022...
  • Page 90 For increased convenience, the AutoStat feature automatically calculates the average, standard deviation, and minimum and maximum values of samples of interest. Select the results of interest by Rotor-Gene Q MDx CE User Manual 02/2022...
  • Page 91 (1 * 2 * 8 * 16)^(1/4) = 4 copies. Dynamic tube normalization The Dynamic Tube option is selected by default and is used to determine the average background of each sample just before amplification commences. Rotor-Gene Q MDx CE User Manual 02/2022...
  • Page 92 If a takeoff point is calculated by the Dynamic Tube that is lower than the first parameter, then the second parameter is used as the takeoff point. The takeoff point adjustment can only be used in conjunction with Dynamic Tube normalization. Rotor-Gene Q MDx CE User Manual 02/2022...
  • Page 93 2 Fl and increased to 47 Fl, then 45 Fl represents 100%. An “NTC Threshold” of 10% would consider any sample less than 4.5 Fl as noise. Rotor-Gene Q MDx CE User Manual 02/2022...
  • Page 94 (e.g., copy number). A 100% efficient amplification means a doubling of amplification product in each cycle resulting in an M value of –3.322, an amplification factor of 2, and a reaction efficiency of 1. Rotor-Gene Q MDx CE User Manual 02/2022...
  • Page 95 This real-time monitoring of data enables the user to see results as soon as the curves show exponential growth. Preliminary conclusions can be drawn and decisions made for the next run. Rotor-Gene Q MDx CE User Manual 02/2022...

  • Page 96: Two Standard Curve

    Expression analysis using the two standard curve method Data can first be analyzed for each gene using quantitation analysis. Otherwise, the results for each gene will automatically be determined using the Autofind Threshold tool. Rotor-Gene Q MDx CE User Manual 02/2022...
  • Page 97 Repeat the procedure for the normalizing gene. Optionally, a calibrator can be defined. If this option is selected, the calibrator is assigned a value of 1 and all other sample concentrations are calculated relative to this sample. Rotor-Gene Q MDx CE User Manual 02/2022...
  • Page 98 Click the Show button to display the relative quantitation report. The Export option exports the results to a new Excel spreadsheet. If a calibrator is included, the results are calculated relative to the calibrator sample, which is assigned a value of 1. Rotor-Gene Q MDx CE User Manual 02/2022...
  • Page 99 5. The concentrations as read from the standard curves for the gene of interest (GOI Conc.) and the normalizing gene (Norm. Conc.), as well as the relative concentration (Relative Conc.) are displayed. The results can be saved as a Word file. Rotor-Gene Q MDx CE User Manual 02/2022...

  • Page 100: Delta Delta C Relative Quantitation

    From the Other tab in the Analysis window, select Delta Delta CT Relative Quantitation. Select New Analysis. * Livak, K.J. and Schmittgen, T.D. (2001) Analysis of relative gene expression data using real-time quantitative PCR and the 2^[–delta delta C(T)] method. Methods 25, 402. Rotor-Gene Q MDx CE User Manual 02/2022...
  • Page 101 2. Enter a name for the analysis. 3. Validation Run Performed must be checked to proceed with the analysis. Define the pages where the gene of interest and normalizing gene have been analyzed. Rotor-Gene Q MDx CE User Manual 02/2022...
  • Page 102 For further information on the derivation of the Rel Min and Rel Max calculations, refer to Litvak and Schmittgen (2001).* * Livak, K.J. and Schmittgen, T.D. (2001) Analysis of relative gene expression data using real-time quantitative PCR and the 2^[–delta delta C(T)] method. Methods 25, 402. Rotor-Gene Q MDx CE User Manual 02/2022...

  • Page 103: Melt Curve Analysis

    After a run has finished, for some chemistries a melt step can be added to visualize the dissociation kinetics of the amplified products. The temperature is increased at a linear rate and the fluorescence of each sample is recorded. A typical melt curve analysis is shown below. Rotor-Gene Q MDx CE User Manual 02/2022...
  • Page 104 Reports This opens the Report Browser where a report can be chosen to preview. A report can be generated based upon the currently selected channel, or a multichannel genotyping report can be generated. Rotor-Gene Q MDx CE User Manual 02/2022...
  • Page 105 Melt analysis templates allow the user to export normalization, threshold, genotype, and bin settings into a single *.met file. This file can be imported and reapplied in other experiments. See Section 7.1 for more details. Rotor-Gene Q MDx CE User Manual 02/2022...

  • Page 106: Comparative Quantitation

    This graph shows a second derivative of an amplification plot, showing the relative positions of the second derivative peak and the takeoff point. * Warton, K., Foster, N.C., Gold, W.A., and Stanley, K.K. (2004) A novel gene family induced by acute inflammation in endothelial cells. Gene 342, 85. Rotor-Gene Q MDx CE User Manual 02/2022...
  • Page 107 The “Rep. Conc.” column of the Comparative Quantitation Results window provides the relative concentration. The relative concentration of each sample compared Rotor-Gene Q MDx CE User Manual 02/2022...

  • Page 108: Allelic Discrimination

    A channel can only be used in one analysis at a time. Reports: This opens the “Allelic Discrimination Analysis” report for preview. Results: This displays the Allelic Discrimination Results window. This window is opened by default when the analysis is first displayed. Rotor-Gene Q MDx CE User Manual 02/2022...

  • Page 109: Scatter Graph Analysis

    2 channels. Unlike allelic discrimination, genotype is decided based on regions defined from the scatter graph rather than from a single threshold. To perform this analysis, select Other and then Scatter Graph Analysis in the Analysis window. Rotor-Gene Q MDx CE User Manual 02/2022...
  • Page 110 To perform genotyping, the user defines regions by clicking and dragging a selection on the graph. The selection can then be labeled based on the genotypes configured in the Genotyping window. Rotor-Gene Q MDx CE User Manual 02/2022...

  • Page 111: Endpoint Analysis

    However in EndPoint analysis, only a single reading is available, in contrast to allelic discrimination, which uses a cycle- by-cycle reading for each sample. This means that the user must identify positive and negative Rotor-Gene Q MDx CE User Manual 02/2022...
  • Page 112 To perform EndPoint analysis, perform a profile with a hold at 50°C for several minutes, then a cycling step with 1 step (50°C for 10 s), acquiring on the required channel. Set the number of Rotor-Gene Q MDx CE User Manual 02/2022...
  • Page 113 EndPoint tab, select the channels by dragging over them with the mouse pointer, and then click Show. Define controls When an EndPoint analysis is opened for the first time, the following message will be displayed if positive and negative controls have not been defined. Rotor-Gene Q MDx CE User Manual 02/2022...
  • Page 114 2. All the negative controls are analyzed, and the one with the lowest fluorescence level is set to be 0%. 3. The raw fluorescence values of the remaining samples are scaled relative to the highest positive control and the lowest negative control. Rotor-Gene Q MDx CE User Manual 02/2022...
  • Page 115 Since this analysis is qualitative, such results are not a concern. If the negative controls result in higher fluorescence than the positive controls, the samples have been incorrectly set up and the following message appears. Rotor-Gene Q MDx CE User Manual 02/2022...
  • Page 116 If the difference between a sample being defined as amplified or not amplified is just a few percent, Rotor-Gene Q MDx CE User Manual 02/2022...

  • Page 117: Concentration Analysis

    *.ent file. This file can be imported and reapplied in other experiments. See Section 8.1 for more details. 6.6.10 Concentration analysis Concentration analysis allows the Rotor-Gene Q MDx to be used to measure DNA concentrations or to obtain fluorometer readings. The screenshot below shows this analysis. Rotor-Gene Q MDx CE User Manual 02/2022...
  • Page 118 Differences have been observed in the measurement of various forms of DNA (e.g., genomic DNA compared to plasmid DNA). Therefore, only similar DNA types should be measured together, and the use of plasmid DNA as a standard should be avoided when measuring genomic DNA. Rotor-Gene Q MDx CE User Manual 02/2022...
  • Page 119 It determines measurement error by examining the deviation of the readings from a linear model. If concentration readings are linear, this is the most suitable analysis because it provides statistical analysis of variation (ANOVA) to the user. Rotor-Gene Q MDx CE User Manual 02/2022...

  • Page 120: High Resolution Melt Analysis

    Autocalling of samples is achieved by clicking Genotypes. Enter the name of the genotype, followed by the sample number, which is used as a positive control to call unknown samples automatically. Rotor-Gene Q MDx CE User Manual 02/2022...

  • Page 121: Run Menu

    (see Section 6.8.1). WARNING Hot surface When pausing a run, the Rotor-Gene Q MDx will not be cooled completely to room temperature. Exercise caution before handling the rotor or any tubes in the instrument. Rotor-Gene Q MDx CE User Manual 02/2022...

  • Page 122: Stop Run

    Machine Options This tab displays settings for the configuration of the Rotor-Gene Q MDx. Rotor-Gene Q MDx CE User Manual 02/2022...
  • Page 123 If viewing an existing run, the information displayed represents the configuration of the channels when the run was performed. If a run corrupts the channel settings, default channels can be restored by clicking Reset Defaults. Rotor-Gene Q MDx CE User Manual 02/2022...
  • Page 124 Rotor- Gene Q MDx. Alternatively, samples can be labeled 1A, 1B, 1C, etc. This option can be useful if samples were set up with a multichannel pipet. Rotor-Gene Q MDx CE User Manual 02/2022...

  • Page 125: Temperature Graph

    For an existing run file, the Temperature window shows the temperature history during the run. The vertical scale represents temperature and the horizontal scale represents time. Use the scrollbar to scroll backwards and forwards through the Temperature window. Rotor-Gene Q MDx CE User Manual 02/2022...

  • Page 126: Profile Progress

    There is also an estimate of how many minutes the run will take to finish. Skip: Skip allows any steps of the profile to be skipped. Add 5 Cycles: Add 5 Cycles adds 5 repeats to the current cycling step. Rotor-Gene Q MDx CE User Manual 02/2022...

  • Page 127: Edit Samples

    This drop-down menu is used to choose a suitable format for the concentration display. Concentrations are automatically formatted according to the currently selected location. This drop-down menu sets the units of measurement for the assay. Rotor-Gene Q MDx CE User Manual 02/2022...
  • Page 128 Standard values are used to construct a standard curve to calculate unknown sample concentrations Calibrator (RQ) A calibrator is assigned a value of 1 and all other sample concentrations are calculated relative to this sample Rotor-Gene Q MDx CE User Manual 02/2022...
  • Page 129 The toolbar will show the default style Solid. This can be changed to Dashed, Dotted, Hairline, Thin, or Thick. When finished, click the left-arrow button to return to the Edit, Reset Default, and Gradient view. Rotor-Gene Q MDx CE User Manual 02/2022...
  • Page 130 It is not possible to define some settings, such as the whether the sample represents a standard or the known concentration of each standard, in this tab. If these need to be defined, the standard tab should be used. Rotor-Gene Q MDx CE User Manual 02/2022...
  • Page 131 1. To define a group, type the full name of the group next to a sample and then press ENTER. Rotor-Gene Q MDx CE User Manual 02/2022...

  • Page 132: Display Options

    3. Define a suitable abbreviation, then click OK. The abbreviation can now be used to set up groups. Aggregate results, such as average value and 95% confidence intervals, are calculated automatically for groups in any analysis. 6.8.5 Display Options The display options menu is shown below. Rotor-Gene Q MDx CE User Manual 02/2022...

  • Page 133: Access Protection For Rotor-Gene Q Software

    Sample names are protected  Integration with Windows security To provide a strong level of accountability, Rotor-Gene Q software does not manage security internally. Accounts, groups, and passwords are all managed using the Windows built-in security Rotor-Gene Q MDx CE User Manual 02/2022...

  • Page 134: Configuration For Windows 7

    Creating a new user account Create user accounts for each user of the software. For each user, repeat the steps below until all accounts have been created. Rotor-Gene Q MDx CE User Manual 02/2022...
  • Page 135 3. Enter a username and password. By default, the user will be created with normal access privileges. This means they can run software but not install new programs or change system settings. 4. Click Create. You can now log on as this user. Rotor-Gene Q MDx CE User Manual 02/2022...
  • Page 136 3. Click Yes. The User Admin window appears. In the top panel, all the users of the computer are displayed. Some accounts are used by the system and so will be unfamiliar. The bottom pane shows the groups assigned to the user. Rotor-Gene Q MDx CE User Manual 02/2022...
  • Page 137 6. Now log in as this user. As an RG Analyst, the Run menu and Profile button are unavailable. However, existing files can be opened and analyzed, as shown in the screenshot below. The status bar indicates that the user linsongy is an RG Analyst. Rotor-Gene Q MDx CE User Manual 02/2022...
  • Page 138 The status bar indicates that the user linsongy belongs to the RG Operator group. 8. If you log in as administrator and remove all groups from the user linsongy, the following message will appear when linsongy opens the software. Rotor-Gene Q MDx CE User Manual 02/2022...

  • Page 139: Configuration For Windows 10

    New User…. 3. Enter a username and password. By default, users will be created with normal access privileges. This means they can run software but not install new programs or change system settings. Rotor-Gene Q MDx CE User Manual 02/2022...
  • Page 140 Groups have to be created in the domain by a domain administrator, also the assignment of users to a specific group. Run menu is enabled. The status bar indicates that the user linsongy belongs to the RG Operator group. Rotor-Gene Q MDx CE User Manual 02/2022...

  • Page 141: Running Multiple Users On The Same Computer

    This ensures a high level of security. Note: Each user should log out after their run has been completed to prevent other users from performing a run in their name. Rotor-Gene Q MDx CE User Manual 02/2022...

  • Page 142: Audit Trails

    This identifier is important to avoid a user creating an account with the same name on another computer and thereby impersonating another user. In this case, the usernames will be the same, but the account IDs will be different. Rotor-Gene Q MDx CE User Manual 02/2022...
  • Page 143 The identifier for the account CORIT001/RGQ User 2, S-1-5-21-1177238915-195, is shown in the details. Rotor-Gene Q MDx CE User Manual 02/2022...

  • Page 144: Run Signatures

    517587770f3e2172ef9cc9bd0c36c081. If the file is opened in Notepad and an edit is made (e.g., the run date is changed to 3 days earlier), the following message appears when the file is reopened. Rotor-Gene Q MDx CE User Manual 02/2022...

  • Page 145: Sample Locking

    RG Operator and RG Analyst groups, and keep the administrator password secret. Users will then require authorization from the administrator to unlock files. Samples can be locked before starting a run when using the Advanced wizard, by clicking Finish and Lock Samples. Rotor-Gene Q MDx CE User Manual 02/2022...
  • Page 146 Once the samples are locked, it will not be possible to edit samples in the Edit Samples window. Samples can also be locked and unlocked in the Edit Samples window. However, only an administrator can unlock samples once they have been locked. Rotor-Gene Q MDx CE User Manual 02/2022...

  • Page 147: Locked Templates

    The gain can be changed during the initial cycles. A red line will be drawn in the appropriate channel showing where the gain was changed. Cycles before the gain change will be excluded from analysis. Rotor-Gene Q MDx CE User Manual 02/2022...

  • Page 148: Window Menu

    Software Version History…: software release. Web Resources: This opens a QIAGEN website page in a new browser window with valuable latest information on Rotor Gene Q MDx instruments and corresponding reagents. About This Software…: This provides information about the connected machine, the serial number of the Rotor-Gene Q MDx, and the software version.

  • Page 149: Send Support E-Mail

    6.12.1 Send Support E-Mail The Send Support Email option in the Help menu allows you to send a support e-mail to QIAGEN including all relevant information from a run. The Save As option will save all the information to a file that you can copy onto a disk or across a network if you do not have access to e-mail on the computer running the Rotor-Gene Q MDx.
  • Page 150 2. Type in your e-mail address and press Next. The E-mail Server Names window will open. 3. Select the type of mail server for incoming mails and specify the server names for incoming and outgoing e-mails. Then press Next. The window Internet Mail Logon will open. Rotor-Gene Q MDx CE User Manual 02/2022...
  • Page 151 5. Confirm with Finish to complete the e-mail account setup. Setting up in Outlook 1. Open Outlook Express from the Start menu (Start > All programs > Outlook Express). 2. Select Tools and then Options. The window below appears. Rotor-Gene Q MDx CE User Manual 02/2022...
  • Page 152 Important: To avoid any retrieval of e-mails during PCR runs, disable the default entries in the Send/Receive Messages screen. 3. Disable Send and receive messages at startup. 4. Disable Check for new messages every 30 minutes. 5. Confirm changes with OK. Rotor-Gene Q MDx CE User Manual 02/2022...

  • Page 153: Additional Functions

    To access Adjust Scale, click on Adjust Scale… at the bottom of the main window or right-click on the graph and select Adjust Scale… on the menu that appears. A scale can be manually entered in the window that appears. Rotor-Gene Q MDx CE User Manual 02/2022...

  • Page 154: Exporting Graphs

    1. Right-click on the image and select Export from the menu that appears. 2. The Export Dialog window appears. Select the desired format from the Format list. 3. Select the Size tab and specify the desired size. Rotor-Gene Q MDx CE User Manual 02/2022...
  • Page 155 Rotor-Gene Q software package. To access the software, click on the TeeChart icon on the desktop. TeeChart Office enables manipulation of exported graphs, including changing colors of curves, adding annotations, changing fonts, and adjusting data points. Rotor-Gene Q MDx CE User Manual 02/2022...
  • Page 156 To export data in various formats, select Data tab in the Export Dialog window. The exported file contains the raw data points used in the graph. Exporting raw data and analysis data can also be performed by selecting Save As under the File menu (see Section 6.5). Rotor-Gene Q MDx CE User Manual 02/2022...

  • Page 157: Spanner/Wrench Icon

    This opens a window that displays the exact coordinates of the mouse pointer position. Grouping: This visually groups samples that have identical names. This can be useful on full rotor runs. Selecting this option does not affect calculated values. Rotor-Gene Q MDx CE User Manual 02/2022...

  • Page 158: Selected Area Options

    Samples outside the selected area are deselected. Samples outside the selected area are deselected. Select Only These Samples: Zoom: This zooms in on the selected area of the graph. Click the Default Scale button to zoom out. Rotor-Gene Q MDx CE User Manual 02/2022...

  • Page 159: Maintenance

    To avoid dust build up, keep the lid of the Rotor-Gene Q MDx closed when the instrument is not in use. Note: Only use parts supplied by QIAGEN. Cleaning the Rotor-Gene Q MDx surface The Rotor-Gene Q external surfaces can be cleaned using commonly available laboratory chemicals.

  • Page 160: Decontaminating The Rotor-Gene Q Mdx Surface

    PCR-grade water to remove traces of bleach. Rotor-Gene Q repair For repair or service of the Rotor-Gene Q contact QIAGEN Technical Services at https://www.qiagen.com/service-and-support/technical-support/technical-support-form/. When working with chemicals, always wear a suitable lab coat, disposable gloves, and protective goggles. For more information, consult the appropriate safety data sheets (SDSs), available from the product supplier.

  • Page 161: Optical Temperature Verification

    (*.rex) * When working with chemicals, always wear a suitable lab coat, disposable gloves, and protective goggles. For more information, consult the appropriate safety data sheets (SDSs), available from the product supplier. Rotor-Gene Q MDx CE User Manual 02/2022...

  • Page 162: Running An Otv

    3. Access the Advanced wizard by selecting the Advanced tab in the New Run window. In the Advanced wizard, click on Instrument maintenance and then OTV. The wizard prompts for the OTV serial number, this is found on the OTV ring. Then click Start. Rotor-Gene Q MDx CE User Manual 02/2022...
  • Page 163 4. The software then prompts for a filename for the run. Then the run begins. 5. The run performs a series of melts that determine the thermal characteristics of the Rotor-Gene Q MDx. Rotor-Gene Q MDx CE User Manual 02/2022...
  • Page 164 After the verification run is complete, no adjustment should be required. If further adjustment is required, contact your distributor. 8. When the Rotor-Gene Q MDx is within specification, a report of the run can be reviewed and printed. Rotor-Gene Q MDx CE User Manual 02/2022...

  • Page 165: High Resolution Melt Analysis

    DNA sequence complementarity. HRM can be used in genotyping applications, such as analysis of insertions/deletions or single nucleotide polymorphisms (SNPs), or to screen for unknown genetic mutations. It can also be used in epigenetics applications for detection and Rotor-Gene Q MDx CE User Manual 02/2022...

  • Page 166: Instrumentation

    The Rotor-Gene Q MDx provides the following demanding real-time and thermo-optical capabilities required for HRM. High-intensity illumination  Highly sensitive optical detection  Fast data acquisition  Finely controlled sample temperature  Minimal sample-to-sample thermal and optical variation  Rotor-Gene Q MDx CE User Manual 02/2022...

  • Page 167: Chemistry

    ® Polymerase to avoid unspecific amplification products and provide reliable results. Note: All QIAGEN HRM kits and reagents are indicated for use with Rotor-Gene Q instruments only for the applications described in the respective QIAGEN Kit handbooks. 10.3 SNP genotyping example...
  • Page 168 Type-it HRM Kit. Homozygous wild type (AA), homozygous mutant (GG), and heterozygous (AG) samples are shown on a standard normalized melt curve and a difference plot normalized to wild type samples. Genotypes for the unknown samples were assigned by the Rotor-Gene Q software. Rotor-Gene Q MDx CE User Manual 02/2022...

  • Page 169: Methylation Analysis Example

    HRM methylation analysis on the Rotor-Gene Q using the EpiTect HRM Kit. standard normalized melt curve and a difference plot normalized to the 50% methylated sample are shown. Rotor-Gene Q MDx CE User Manual 02/2022...

  • Page 170: Guidelines For Successful Hrm Analysis

    GC content, or repeat sequences can all affect the outcome. In addition, use of standardized kits and optimized protocols from QIAGEN can overcome many of the potential challenges listed. Some simple guidelines to help ensure success are detailed below.
  • Page 171 HRM data from such samples can be inconclusive or of low resolution. To avoid unreliable results, we recommend QIAGEN kits for sample preparation and HRM analysis. Keep postamplification sample concentrations similar The concentration of a DNA fragment affects its melting temperature ( ).

  • Page 172: Sample Preparation

    To improve HRM results, we recommended keeping the amount of template used consistent between samples. Spectrophotometric analysis for determining DNA concentration and purity is recommended. We recommend QIAGEN kits for sample preparation. Note: At 260 nm one absorbance unit is equal to 50 µg/ml DNA. Pure DNA will provide a 260 nm to 280 nm ratio of 1.8.
  • Page 173 Locking Ring Attached checkbox is checked before proceeding to the next step. 3. Set the run details. Enter the operator name (optional) and add any notes about the experiment (optional). Select the reaction volume (required) and sample layout desired. Rotor-Gene Q MDx CE User Manual 02/2022...
  • Page 174 5. Set an appropriate initial hold time. This time depends on the type of DNA polymerase used. The Type-it HRM PCR Kit and the EpiTect HRM PCR Kit require a 5 min activation time. The default activation time is 10 min. Rotor-Gene Q MDx CE User Manual 02/2022...
  • Page 175 6. Modify the cycling to suit the amplicon. 7. Ensure fluorescence data will be acquired. Acquire data to the green channel at the end of the anneal step. Rotor-Gene Q MDx CE User Manual 02/2022...
  • Page 176 1 and 3 Fluorescence units. To change this setting, click the channel name to select it in the list and then click the Edit button. Rotor-Gene Q MDx CE User Manual 02/2022...
  • Page 177 10. Start the run by clicking Start Run and save the run file to your computer. Rotor-Gene Q MDx CE User Manual 02/2022...

  • Page 178: Real-Time Pcr Data Analysis

    3. Use the Comparative Quantitation option from the Analysis window to obtain the reaction efficiency of each sample. If the efficiency is not similar to other reactions in the experiment, or is less than approximately 1.4, omit the reaction as an outlier. Rotor-Gene Q MDx CE User Manual 02/2022...

  • Page 179: Hrm Data Analysis

    HRM analysis. This is because any derivation of the data adds artificial noise and makes data interpretation more difficult. The following steps describe the analysis of HRM results using Rotor-Gene Q software. 1. Select the HRM option from the Analysis window. Rotor-Gene Q MDx CE User Manual 02/2022...
  • Page 180 Widening the regions (by clicking and dragging) allows the software to adjust for the slope of the baseline. To ensure curves normalize effectively, avoid widening the normalization regions into the melt phase. Rotor-Gene Q MDx CE User Manual 02/2022...
  • Page 181 5. View the difference plot by selecting the Difference Graph tab. Then select the genotype you wish to compare all other samples against using the drop-down menu at the top of the Rotor-Gene Q MDx CE User Manual 02/2022...
  • Page 182 The threshold value, above which autocalls are made, can be edited. Samples that fall below the set threshold will be marked as a variation for closer investigation or retesting. Rotor-Gene Q MDx CE User Manual 02/2022...

  • Page 183: Troubleshooting

    Website: support.qiagen.com When contacting QIAGEN Technical Services about an error with the Rotor-Gene Q MDx, note the steps leading up to the error and any information appearing in any dialog boxes. This information will help the QIAGEN Technical Services solve the problem.

  • Page 184: Log Archives

    Archive repository. By using the Help, Send Support Email option, you can send an e-mail along with all the necessary diagnostic information to QIAGEN Technical Services (see Section 6.12.1). To save disk space, only Log Archives of the 60 most recent runs are stored. Older run Log Archives will be overwritten as new run Log Archives are created.

  • Page 185: Error And Warning Messages

    The software has stopped the run. This run was stopped as machine errors occurred that could not be Try another run. If the problem persists, contact your distributor or QIAGEN recovered from. Please contact your Technical Services and attach a support archive file.
  • Page 186 Time out while setting the rotor speed. Further investigations are required by a QIAGEN Field Service Specialist to diagnose the problem with the instrument. Please contact your distributor or QIAGEN Technical Services.

  • Page 187: Rotor-Gene Q Software Messages

    The serial number entered in the welcome screen <SERIAL NUMBER1> does not match the serial number stored in the attached machine <SERIAL NUMBER2>. The computer's serial number has now been updated to match the connected machine. Rotor-Gene Q MDx CE User Manual 02/2022...
  • Page 188 You cannot start until you tick the checkbox to confirm that the fluorescent insert has been placed correctly. This rotor has expired. Please contact your distributor to obtain a replacement. Security menu messages Could not open the Windows user/group manager. Rotor-Gene Q MDx CE User Manual 02/2022...
  • Page 189 SHIFT key on each channel. Quantitation analysis messages The auto-find threshold feature requires that you have defined at least 2 selected standards. To set this up, right-click on the sample list and select “Edit Samples...” Rotor-Gene Q MDx CE User Manual 02/2022...

  • Page 190: Glossary

    The rotor is secured with a Locking Ring. Rotor-Disc Rotor-Discs are circular plates of vertically oriented reaction wells. Rotor-Disc formats for 72 and 100 reactions are available. Rotor-Discs are sealed using Rotor-Disc Heat Sealing Film and the Rotor-Disc Heat Sealer. Rotor-Gene Q MDx CE User Manual 02/2022...

  • Page 191: Technical Specifications

    13 Technical Specifications QIAGEN reserves the right to change specifications at any time. 13.1 Environmental conditions – operating conditions Power 100–240 V AC, 50–60Hz, 520 VA (peak) Power consumption 60 VA (standby) Mains supply voltage fluctuations are not to exceed 10% of the nominal supply voltages.

  • Page 192: Specifications (Hardware And Software)

    (50°C to 99°C for cycling applications) Temperature accuracy ±0.5°C (calibrated using Rotor-Disc OTV procedure) Temperature resolution ±0.02°C (smallest programmable increment) Temperature uniformity ±0.02°C 13.5.2 Optical specifications Description Specification Excitation sources High energy light-emitting diodes Detector Photomultiplier Acquisition time Rotor-Gene Q MDx CE User Manual 02/2022...

  • Page 193: Appendix A - Legal

    Increase the separation between the equipment and receiver  Connect the equipment into an outlet on a circuit different from that to which the receiver is  connected Consult the dealer or an experienced radio/T.V. technician for help. Rotor-Gene Q MDx CE User Manual 02/2022...

  • Page 194: Iec En 61326 Compliance

    The Rotor Gene-Q MDx complies with the requirements for interference emissions and interference immunity described in IEC 61326-1 and IEC 61326-2-6. QIAGEN GmbH Germany is not responsible for any radio television interference caused by unauthorized modifications of this equipment or the substitution or attachment of connection cables and equipment other than those specified by QIAGEN GmbH, Germany.

  • Page 195: Declaration Of Conformity

    14.3 Declaration of Conformity Name and address of the legal manufacturer QIAGEN GmbH QIAGEN Strasse 1 40724 Hilden Germany An up-to-date Declaration of Conformity can be requested from QIAGEN Technical Services. Rotor-Gene Q MDx CE User Manual 02/2022...

  • Page 196: Waste Electrical And Electronic Equipment (Weee)

    Recycling can be provided by QIAGEN upon request at additional cost. In the European Union, in accordance with the specific WEEE recycling requirements and where a replacement product is being supplied by QIAGEN, free recycling of its WEEE-marked electronic equipment is provided.

  • Page 197: Liability Clause

    Representations and warranties made by any person, including representatives of QIAGEN, which are inconsistent or in conflict with the conditions in this warranty shall not be binding upon the Company unless produced in writing and approved by an officer of QIAGEN.

  • Page 198: Software License Agreement

    14.6 Software License Agreement 1. In the following "Qiagen" refers to Qiagen GmbH and its affiliated companies and "Software" means the programs and data supplied on this physical medium (eg. CD-ROM) or over the Internet with these conditions. (If you are unsure of any aspect of this agreement or have any questions they should be emailed to support@qiagen.com.) The Software and any accompanying documentation...
  • Page 199 Qiagen may terminate this licence. 3.2 Within 7 days of termination of this licence, you will furnish to Qiagen a letter attesting to the destruction of the original and any copies of the Software and the destruction of all copies of any registration/licence key.
  • Page 200 DAMAGES FOR LOSS OF GOODWILL, WORK STOPPAGE, COMPUTER FAILURE OR MALFUNCTION, OR ANY AND ALL OTHER COMMERCIAL DAMAGES OR LOSSES, EVEN IF QIAGEN SHALL HAVE BEEN INFORMED OF THE POSSIBILITY OF SUCH DAMAGES. IN ANY CASE QIAGEN'S ENTIRE LIABILITY UNDER THIS AGREEMENT WILL BE LIMITED TO THE LICENCE FEE PAID BY YOU FOR THE SOFTWARE.

  • Page 201: Appendix B - Mathematical Techniques

    Suppose now we have k further observations at x = x0 and we denote their average by . Then, and arguments similar to above give This formula determines how confidence intervals for concentrations of replicate unknowns are determined. Rotor-Gene Q MDx CE User Manual 02/2022...

  • Page 202: Confidence Intervals For Ct Values

    . Then, a 100(1– α)% confidence interval for a CT value µ is: We would like to thank Peter Cook from the Mathematics Department of the University of NSW, Sydney, Australia, whose help was invaluable in verifying the mathematical approaches used. Rotor-Gene Q MDx CE User Manual 02/2022...

  • Page 203: Ordering Information

    3000 reactions Rotor-Disc 100 (300) 10 x 30 individually wrapped 981313 discs for 30,000 reactions Rotor-Disc 100 Rotor For holding Rotor-Disc 100 discs 9018895 in the Rotor-Gene Q MDx; requires Rotor-Disc 100 Locking Ring Rotor-Gene Q MDx CE User Manual 02/2022...
  • Page 204 250 strips of 4 tubes and caps for 981103 0.1 ml (250) 1000 reactions Strip Tubes and Caps, 10 x 250 strips of 4 tubes and 981106 0.1 ml (2500) caps for 10,000 reactions Rotor-Gene Q MDx CE User Manual 02/2022...
  • Page 205 For up-to-date licensing and product-specific disclaimers, see the respective QIAGEN kit handbook or user manual. QIAGEN kit handbooks and user manuals are available at www.qiagen.com or can be requested from QIAGEN Technical Services or your local distributor. Rotor-Gene Q MDx CE User Manual...

  • Page 206: Document Revision History

    17 Document Revision History Date Changes R1, February 2022 Initial release Rotor-Gene Q MDx CE User Manual 02/2022...
  • Page 207 QIAGEN specifically disclaims any other licenses, expressed or implied other than those expressly stated. The purchaser and user of the kit agree not to take or permit anyone else to take any steps that could lead to or facilitate any acts prohibited above. QIAGEN may enforce the prohibitions of this Limited License Agreement in any Court, and shall recover all its investigative and Court costs, including attorney fees, in any action to enforce this Limited License Agreement or any of its intellectual property rights relating to the kit and/or its components.
  • Page 208 Ordering www.qiagen.com/contact | Technical Support support.qiagen.com | Website www.qiagen.com HB-3090-001 02/2022 Rotor-Gene Q MDx CE User Manual 02/2022...

This manual is also suitable for:

900202290020329002042

Table of Contents