Diomni™ Software for Diomni Enterprise IVD, 1-year license - FAQs

No. The amplification plots will not display in real-time. During the run, you will see the instrument status and the run time remaining on the experiment.

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No, this is not supported with the current release of Diomni Software.

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Red is used to display positive test results in the Presence/Absence application because molecular diagnostic tests routinely screen for pathogens. The red is used as a warning flag to draw attention to a positive test result.

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An external barcode scanner acts as a keyboard emulator and can be used to enter sample IDs, plate IDs, and reagents. Thermo Fisher Scientific reagent barcodes are designed to allow population of reagent name and part number when setting up an extraction or qPCR run. The user may enter lot number and expiration date manually.

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In Diomni Enterprise IVD Software, expired reagents will display a warning in the RUO workspace for extraction and qPCR runs and will be noted on the report if reagent information is included. Expired reagents cannot be used in the IVD workspace and the software will not allow the user to save or start a run with expired reagents.

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Reagents used in extraction runs and qPCR runs can be tracked in the Diomni Enterprise Software dashboard by searching for reagent name, lot number.

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Please refer to the Licensing Activation instructions which can be accessed at thermofisher.com/diomni/licenseinstructions.

When installed, Diomni Software will first appear as the standard Diomni version. The user should then connect qPCR instrument(s) which may appear as inactive. The user activates the license using the printed Activation ID associated with each instrument covered by a premium service contract. Activation IDs can be added from the Diomni instrument management page, and Diomni will automatically refresh to reveal the Diomni Software Enterprise version as indicated on the UI.

Find additional tips, troubleshooting help, and resources within our Real-Time PCR and Digital PCR Instruments Support Center.

Please refer to the Licensing Activation instructions which can be accessed at thermofisher.com/diomni/licenseinstructions.

When installed, Diomni Software will first appear as the standard Diomni version. The user should then connect qPCR instrument(s) which may appear as inactive. The user activates the license using the printed Activation ID associated with each instrument covered by a premium service contract. Activation IDs can be added from the Diomni instrument management page, and Diomni will automatically refresh to reveal the Diomni Software Enterprise version as indicated on the UI.

Find additional tips, troubleshooting help, and resources within our Real-Time PCR and Digital PCR Instruments Support Center.

Yes, the same license can be used with multiple installations of Diomni Software to connect to the same instrument.

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SAE Dx Software requires that the time configured on all connected devices/applications is within 5 minutes of the SAE Dx system time. While QuantStudio7 Pro and QuantStudio7 Pro Dx instruments with an internet connection support automatic time syncing, QuantStudio5 and QuantStudio5 Dx instruments do not support automatic time syncing. To avoid issues during setup and in the future, it is imperative to ensure the time on all connected devices/applications is as close as possible to the time on the SAE Dx system. Note: SAE Dx Software relies on the Windows operating system time on the computer it is installed on.

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The following ports should be open for proper communication with Diomni Software: TCP 8443, 7743, 9443, 445, and UDP 5353.

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Diomni Enterprise Software v4.0 has no limit on the number of KingFisher Apex Dx instruments that can be connected. On the other hand, Diomni Software v4.0 Standard version, that comes with a QuantStudio7 Pro Dx instrument, does not provide an extraction module and it is not possible to connect an extraction instrument.

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If you get a browser warning that access to Diomni Software is blocked, the immediate workaround is to click on the link to proceed anyway. Alternately, you may click on the page (not the URL) and type 'thisisunsafe' which should bypass the browser warning. The permanent fix is to install an updated certificate. Instructions can be found in EducationConnect - Diomni Software Course Video. To sign up for the course, please do the following:

- Go to thermofisher.com/educationconnect to log in
- Click on the EducationConnect logo at the top left
- Choose 'Click Here' under the 'PCR' section
- In the Filter Search, enter 'Diomni'
- Click to enroll and view the course video

Find additional tips, troubleshooting help, and resources within our Real-Time PCR and Digital PCR Instruments Support Center.

Diomni Software is not installed with a security certificate issued by a trusted certificate authority (CA), and this may trigger a warning message in your browser. Please note that this warning does not necessarily indicate an immediate security threat. To remove the warning, you can choose to install the provided self-signed certificate. Follow the instructions in EducationConnect Diomni Software Video to install the certificate. To view the video, please sign up for the course:

- Go to thermofisher.com/educationconnect to log in
- Click on the EducationConnect logo at the top left
- Choose 'Click Here' under the 'PCR' section
- In the Filter Search, enter 'Diomni'
- Click to enroll and view the course video

Find additional tips, troubleshooting help, and resources within our Real-Time PCR and Digital PCR Instruments Support Center.

Please check for the following:
- KingFisher Apex Dx user must be logged into the SAE Administrator Console Dx Software.
- Instrument must be on and connected to the network.
- Ensure that the shared folder is correct.

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We can provide documentation including a LIS/LIMS checklist, a Diomni ASTM Communication Specification, and information found in the User Guides to describe the configuration of Diomni Software and network connection between the LIS/LIMS. Because each LIS/LIMS is different, it is the customer's responsibility to ensure integration with their IT team, and Thermo Fisher Scientific is only able to provide support by providing documentation and assisting with cybersecurity questionnaires.

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No. Diomni Software supports 2 types of LIS integration:
- ASTM bi-directional communication with LIS/LIMS
- Shared file-based transfer using a configurable output file via SMB

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Diomni Software supports bi-directional LIS/LIMS communication via ASTM. The software supports receipt of a worklist with required information of sample ID, test order, and received date (accession date), and optional information of specimen and priority. Upon run completion and analysis, configurable results can be released to the LIS/LIMS system via ASTM, upon user request, and/or results reporting can be automated after run completion and analysis.

Diomni Software continues to support file-based transfer that was introduced in v3.1 whereby the export content and file format can be configured to output results to a shared folder that is accessible by LIS/LIMS. This can be automated upon run completion and analysis.

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The export content and file format can be configured to output results to a shared folder that is accessible by LIS/LIMS. This can be automated upon qPCR run completion.

Find additional tips, troubleshooting help, and resources within our Real-Time PCR and Digital PCR Instruments Support Center.

The KingFisher Apex Dx instrument can only be connected in the licensed version of the Diomni Enterprise Software. Before you begin, verify that you have connected at least 1 qPCR instrument and activated the license. Refer to the system configuration for recommended Local Area Netork (LAN) setup up.

Troubleshooting steps include the following:

- Work with your IT or system administrator to set up the required shared folder in the Diomni host/server computer.
- Verify that a reserved ethernet port is connected to the KingFisher Apex Dx instrument through a LAN.
- Verify that the KingFisher Apex Dx instrument time is set to match the time displayed on the host/server computer where the SAE Administrator Console Dx software is installed (± 5 mins).

If you are still unable to connect, contact Thermo Fisher Scientific remote hardware support at instrumenthardwaresupport@thermofisher.com.

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No. Diomni Software has not been validated on the QuantStudio 5 Dx instrument computer. It must be installed on a separate computer.

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No. Diomni Software does not affect the instrument/computer setup and thus, a new IQ/OQ is not needed.

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Yes, you can use a 2D barcode scanner (Cat. No. 4488442 or equivalent) with Diomni Software. Please note that you must first configure the scanner using the instructions in the User Guide.

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Diomni Enterprise IVD Software v4.0 is compatible with the CE-IVD marked real-time PCR instruments, QuantStudio 7 Pro Dx Real-Time PCR System and QuantStudio 5 Dx Real-Time PCR System. Diomni Enterprise IVD Software v4.0 also supports sending RUO-labeled qPCR runs to the RUO real-time PCR instruments, QuantStudio 7 Pro Real-Time PCR System and QuantStudio 5 Real-Time PCR System. Compatibility is restricted based on licensing.

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Diomni Software v3.1 IVD workspace supports the user to send an IVD-labeled run to CE-IVD marked real-time PCR instruments, QuantStudio 7 Pro Dx Real-Time PCR System and QuantStudio 5 Dx Real-Time PCR System.

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Diomni Software v3.1 RUO workspace supports the user to send an RUO-labeled run to the RUO real-time PCR instruments, QuantStudio 7 Pro Real-Time PCR System and QuantStudio 5 Real-Time PCR System.

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If the qPCR was initiated from an ADF, Diomni Software will be able to import all of the EDS file and data analysis. Older ADF versions may not include all the information needed in newer versions of Diomni Software and the user will be prompted to review the ADF.

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No, this is not possible. An ADF that was created for an RUO instrument cannot be published to IUO or IVD status.

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All qPCR runs can be started directly from Diomni Software for all compatible qPCR instruments without the need to install an ADF on the instrument. This can be performed by selecting ''Save & start run''.

The QuantStudio 7 Pro Dx instrument has additional start run options which require that a compatible ADF is installed on the instrument, e.g., ''Save & send to queue''.

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Yes, in the Diomni Software Results tab, select the completed run and the ADF name is shown in blue towards the top left, below the main header in the Summary tab. To see additional information with the ADF, click the ADF name.

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In Sample Call settings, assay developers can define the text for each quantitative bin result in addition to the target quantity and reporting unit. For example, ''Target detected greater than assay linear range", ''Target detected'', ''Target detected less than assay linear range'',''Target not detected'', etc.

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The conversion factor is a predetermined multiplier to convert the primary measurement to an international measurement traceable to international standards.

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'International Unit'' can be used by assay developers to define the preferred reporting unit other than the primary reporting unit. This is a custom text field; for example, the primary reporting unit is ''copies/mL'' and the International Unit can be ''IU/mL'' or ''IU/µL''. A conversion factor is required to convert primary measurement to secondary measurement.

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Amp Score is a value that indicates the quality of the amplification curve. Amp Score has a range of 0 to infinity.

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Cq Confidence is a value that reflects the reliability of the derived Cq. Cq Confidence has a range of [0,1].

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When ''Curve Quality Indicator (CQI)'' is turned on, the software will apply a default set of proprietary amplification curve QC flags with predefined threshold settings to the selected target and sample. If enabled, the result table quality issue field will annotate the affected target.

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The text defined in the ''Invalidation Assessment'' will replace the sample test result text in a failed run if the run control is toggled on to invalidate calls.

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Yes, in the Assay Development workspace, a user may define test codes when creating an RUO ADF and assign reportable targets used to interpret a test result.

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Each ADF represents an individual assay. Diomni Software supports multi-assay setup by adding up to 5 compatible ADFs during the run setup, either manually or by creating a template.

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''Apply IPC validity'', found in Controls tab, is intended for Standard Curve run control validation. ''IPC detection required for positive sample calls'', found in Sample Call settings tab, is intended for Standard Curve unknown sample validation. Both will require IPC target and acceptable target Cq range defined.

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