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README�

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QuantStudio™ Dx Software v1.0.3�

For QuantStudio™ Dx Real-Time PCR System�

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OVERVIEW�

FEATURES

UPDATES

DEFECTS FIXED

LICENSE�

COMPATIBILITY�

KNOWN ISSUES�

SYSTEM REQUIREMENTS�

INSTALL SOFTWARE�

UNINSTALL SOFTWARE�

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QuantStudio™ Dx Software v1.0.3 supports the QuantStudio™ Dx Real-Time PCR System

when running IVD assays. The QuantStudio™ Dx Software allows the user to create a test file

from a Test Definition Document that defines the protocol for an IVD assay, send tests to the

instrument, collect data and analyze the collected data all in a streamlined fashion.

The QuantStudio™ Dx System can only be installed and maintained as sold. If the device is

modified by the customer or any third party, Thermo Fisher Scientific is not responsible or liable

in any way for any such modifications or any other configurations to the system. The network

configuration and security settings of your laboratory or facility (e.g., firewalls, anti-virus

software, network passwords) are the sole responsibility of your facility administrators and IT

and security personnel. QuantStudio Dx Software does not provide any network or security

configuration files, utilities, or instructions. If external or network drives are connected to the

QuantStudio Dx Instrument System, it is the responsibility of your IT personnel to ensure that

such drives are configured and secured correctly to prevent data corruption or loss. If a

Laboratory Information Management System (LIMS) is configured to retrieve analysis files from

the QuantStudo Dx Instrument System, manual File Transfer Protocol (FTP) setup or drive

mapping is required. This configuration is not provided as part of QuantStudo Dx Instrument

System installation, and must be set up by your LIMS integration or IT group. �

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• Creating a test file from a Test Definition Document that contains all of the parameters

necessary to perform the instrument run and subsequent analysis for a specific Assay

type.�

• Entering sample-specific information for a particular plate to set up a new run.�

• Real-time monitoring of amplification curves enables you to view a run in progress (can

be viewed from a remote PC as well).�

• Manual baseline and threshold for simplified data analysis.�

• Multiple plots view for simultaneously assessing data from four perspectives.�

• Troubleshooting flags to help you diagnose and solve problematic runs.�

• Tool tips for easy identification of sample wells when viewing amplification curves or

other data plots.�

• Email notifications to alert you when a run has started or ended.�

• Export data easily to Excel® software or as a .jpeg file.�

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v1.0.3

• Software has backwards compatibility with files from QuantStudio™ Dx Software v1.0.1

• Enhancements to multiplex commenting, including:

� Multi-select in Well Table to comment on multiple wells per targets in one click.

� Comments can be added by-target-by-well for up to 4 targets per well in each

analysis plot's Plate Layout and Well Table.

� Include all comments and results of "Run Results Valid?" in the exported data.

� Changed the default comment from blank to “No comment assigned” when the

“Run Result Valid?” is "Yes".

� Warn the user when at least one target is marked as “No comment assigned” or

blank in Results table or Setup table during the export.

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• Enhancements to the PDF report in the following areas:

� Applied font size 10 in Results Table.

� Persist well table's sorting in Results table of PDF report.

� Allowed to display very long Target and Sample name in the Results Table of

PDF report.

� Standardize the display format for all the well information in Plate Layout.

� Display the converted CT value in CT column when "Convert to Undetermined"

checkbox is enabled.

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• Removed the need for a Base license to install the software. Only the HRM feature

requires a paid license.

• Added the Melt Curve Raw tab to the export table.

• Added the ability to allow the user to download and open the RNaseP file for

QuantStudio Dx Software.

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• Added the Test Definition Name and Version to the PDF report in Test Summary section.

• Enabled the custom dye feature in QuantStudio Dx Software.

• Added a new checkbox in the pdf report to display the Result Table by Sample Name.

• Added functionality for the software to track the action when the user deletes the files

from the software (via File Manager).

• Support Automation API.

• Support Batch Test File Utility to allow user to create batch test files from an eds setup

file.

• Support "Help" and "Export" command in the command line utility.

• Remove computer operating system validation from the installer and application.

v1.0.1�

• Software installation aborts if computer operating system is not Windows® 7.�

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v1.0.3

• Fixed issue where the audit trail is incorrect.

• Fixed issue with the printing when e-signature is enabled.

• Fixed issue with the Functional Access Control roles to disallow the user that has "run

only" rights to edit the experiment file.

• Fixed issue where the well information is displayed incorrectly in the plate layout of PDF

report for Genotyping files.

• Fixed issue with the installer not supporting the "Upgrade" function.

• Fixed issue where the software couldn’t be installed /uninstalled to/from a computer that

has only C drive.

• Fixed issue with the “SMCluster” flag not being shown in the PDF report while it is

visible in the QC summary table.

• Fixed issue for users without Administrator rights not being able to export the file to xlsx

format (can see the progress bar, but the file is not generated) unless the user launches the

software via “Run as administrator”.

• Fixed issue with Barcode information missing in the Experiment Summary Section of the

PDF report.

• Fixed issue where the "Date Created" was displayed incorrectly as 24 hour format in

exported file.

• Fixed issue with TDD file extensions in upper case, the software should accept both

upper case and lower case of the extension for TDD file.

• Fixed issue with the TDD file launching as a *. eds file directly in QuantStudio Dx

Software by double clicking the file.

• Fixed issue with incorrect block type displayed in TDD file's description.

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• Fixed issue where the creation time shown in the RNase P calibration's report is incorrect.

• Fixed issue with the CT value showing as "empty" or max number of cycles in well table

when the CT cannot be calculated, it now shows as "Undetermined" in the well table.

• Fixed issue with the NOAMP flag in a multiplex file being triggered per well, it is now

triggered per target.

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See accompanying End User License Agreement for details. You must agree to the terms of the

license before installing or using the software.�

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• The software can open test files created with QuantStudio™ Dx Software.�

• The software cannot communicate with non- QuantStudio™ Dx instruments.�

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v1.0.3

• The text in the PDF report for the Results table might be truncated if the PDF is saved via

the “Save” button in the Print Preview screen of the report when the text width is close to

the column width. This can be avoided by saving the PDF report via the “Print” button

(print to PDF).

v1.0.1 �

Performance�

• Software can operate continuously for at least 5 days. However, we recommend that you

re-launch the software application after 5 days of continuous operation for optimal

performance.�

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SAE�

• In the Audit Record and Audit Report, the word “Experiment” refers to “Test”.�

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The computer hardware and operating system requirements for the QuantStudio™ Dx Software

are:

• Windows® 7 (32-bit or 64-bit) with Service Pack or Windows® 10 (64-bit)

• Pentium 4 or compatible, with minimum 4GB of RAM and 500 GB of hard drive

capacity

• Minimum monitor resolution of 1280x1024

• One open Ethernet port for connecting to the instrument directly

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• Internet Explorer® 6.0 or higher (for online assay browsing and ordering)

• Microsoft® PowerPoint® software (for direct export into PowerPoint slides)

• Microsoft® Excel® software� �

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IMPORTANT - To help prevent data loss, it is strongly advised that all user data is backed

up before upgrading the software.

• Log on to the Windows system with Administrator privileges.

• Obtain the software installation package.

• Place the USB drive in the USB port and look for installer folder. Double click

the setup.exe file on the installer folder to start the installation.

• Agree to the End User License Agreement (EULA) when prompted and complete the

installation.

• The QuantStudio™ Dx Software v1.0.3 does not require a license key for activation.

Follow the instructions in the installation wizard to complete the installation.

• The software will be installed, by default, to following path:

� C:\Applied Biosystems\QuantStudio Dx Software v1.0.3

� C:\Applied Biosystems\AppData\QuantStudio Dx Software v1.0.3

� C:\Program Files (x86)\Applied BioSystems\QuantStudio Dx Software v1.0.3

(referred to as the home directory of the QuantStudio™ Dx Software)

• A program group, “Applied Biosystems/QuantStudio™ Dx Software” will be created

during installation. In addition, a short cut to the application, “QuantStudio™ Dx

Software” will be installed on the computer desktop.

• When a previous version of the software is detected on the system, the installer will

perform an upgrade. The user will be prompted to proceed with the upgrade or to cancel

the operation.� �

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IMPORTANT: To prevent data loss, it is strongly advised that all user data is backed up

before uninstalling the Software.�

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• From Windows “Start” button, find the “Applied Biosystems/ QuantStudio™ Dx

Software” program group.�

• Click on “Uninstall QuantStudio™ Dx Software”.�

• In the wizard, follow the instructions and complete the uninstall operation.�

• Optionally, rename or delete the home directory of the QuantStudio™ Dx application.

This ensures a clean environment for the next installation.��

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© 2019 Thermo Fisher Scientific Inc. All rights reserved. All trademarks are the property of

Thermo Fisher Scientific and its subsidiaries unless otherwise specified. Windows and

Internet Explorer are trademarks of Microsoft Corporation.

Customer is responsible for any validation of assays and compliance with regulatory

requirements that pertain to their procedures and uses of reagents and/or instruments.

For In Vitro Diagnostic Use.

TO THE EXTENT ALLOWED BY LAW, LIFE TECHNOLOGIES AND/OR ITS AFFILIATE(S) WILL NOT BE

LIABLE FOR SPECIAL, INCIDENTAL, INDIRECT, PUNITIVE, MULTIPLE OR CONSEQUENTIAL

DAMAGES IN CONNECTION WITH OR ARISING FROM THIS DOCUMENT, INCLUDING YOUR USE OF

IT.

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