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Abbreviations

AP	Assay plugin
CV	Coefficient of variation
FF	FastFinder
LIMS	Lab information management system
QC	Quality control
SD	Standard deviation

General info

The quality control module can be used for tracking your control results. Quality Control (QC) tracking is configured per assay plugin (AP). In the QC module, an overview of the APs that have QC tracking enabled is found (Figure 1). QC trackings can easily be added or inactivated.

Activating the Quality control module

To be able to use QC tracking in FastFinder, the QC module needs to be activated. This is either done automatically (by UgenTec) when this module is part of the contract or activated at a later moment. In this case, users can activate the QC module in FastFinder (Figure 2). UgenTec will then contact the customer to confirm the activation and perform the necessary actions to start using the QC module.

Adding a new assay plugin

To activate QC tracking for a new AP, the following steps need to be done:

1. Navigate to the Quality control module in FastFinder (left column).
2. Search for the AP. If it is not yet listed, it can be added by clicking on 'Add new QC tracking' (Figure 3, A).
3. Search for the correct AP, select it and subsequently add it to the QC module by clicking on 'Add selected' (Figure 3, B).

(In)activating an assay plugin

When it is no longer needed to follow an AP in the QC module, the QC tracking of the AP can be inactivated. This can be done as follows:

1. Navigate to the QC module in FastFinder.
2. Go to the QC tracking of the AP that needs to be inactivated (either by selecting it from the list or by using the search field).
3. Select the AP.
4. Toggle the button next to 'Status' to inactivate the QC tracking for an AP (Figure 4). The AP will be greyed-out and no longer be visible in the overview.

Note: it is always possible to access and/or re-activate an AP that has been inactivated by clicking on the cogwheel (top right corner of the middle pane) opening the QC trackings list settings and choosing 'Show inactive QC trackings' (Figure 5).

Setting up Quality control tracking

A QC tracking is configured per assay plugin. 

It needs to be decided whether to track per instrument type or per individual instrument:

• Per instrument type:
  The data for all instruments of the same type within the lab are visualized and evaluated together.

• Per individual instrument:
  The data from every unique instrument identifier can be visualized and evaluated.

Furthermore, you can choose which control type you want to track. Tracking can be configured per target in every control sample type (Figure 6, A). Per target, you need to decide which ‘Metric’ (e.g. Cq or (raw) End Fluorescence) needs to be tracked. The mean and standard deviation (SD)/coefficient of variation (CV) needs to be manually added (Figure 6, B). 

Once all the QC metrics are set up, the QC data will be visualized using a Levey-Jennings graph. This includes data from all (historical) authorized runfiles with this plugin in FastFinder. Note that data is tracked historically and retrospectively, i.e., when QC tracking is enabled, previously authorized data prior to this setup is also included in the QC chart. In the graph, you can click on a certain data point and have the ability to go to the applicable Target Results if desired.  

If a metric is updated during the tracking, in the ‘Historic tracking configurations’ section, there is an overview of the adaptations made along the tracking period (Figure 6, C). It is also mandatory to add a comment when changing one of the metrics, for example, lot number information.

Westgard rules

Alerting in FastFinder Analysis can be set up by using Westgard rules. They can be set up by navigating to Quality control under Settings (Figure 7). Rules can be activated by toggling the button after which they will be applied to new analyses. You can choose if you want to implement one or more Westgard rules. If all rules are toggled off, no warning or error messages are received upon tracking. However, in the QC module itself, you can always follow up on the control results.

See Settings - Quality control

Quality Control integration in Analysis

QC is also integrated in the Analysis module on the FastFinder platform. This allows users to easily access QC tracking data. This includes data per target per control type for which QC tracking is enabled, e.g. historic tracking over time, possible violations, …

In the Control results section (Summary tab), it is shown whether or not the control complies with the conditions specified in the QC module (Figure 8). Here, users can quickly review the status of the QC tracking. 

 

If more detailed information is required, users can navigate to the Quality Control tab within the Analysis module. This tab contains all details regarding QC tracking (Figure 9). Data is shown for each target per control sample type, including the Levey-Jennings chart displaying the historic data over time. 

In case of a violation of the Westgard rules, this information can be found under the relevant target(Figure 10). A violation is handled as an error notification and therefore always requires manual review. There are two options: confirm or ignore the violation.

• Confirm
  The user agrees with the violation, which will result in the control sample that is made invalid. The point in the Levey-Jennings chart will be shown in red. It is up to the user to decide to mark all samples for this assay for retest because of this violation or not (see explanation below).In the analysis itself, the decision tree will be executed taking into account an invalid control sample. 

• Ignore
  The user accepts the data as it is and the control will be considered as valid according to the QC. The user can proceed to authorize the analysis. In the Levey-Jennings chart, the point will be shown in black. Note, in this case, it is mandatory to enter a comment that is added to the audit trail. 

It can also be chosen to mark all samples for retest on a control based results (Figure 10), invalidating all samples for that assay in the analysis. This will also be shown in the Analysis results CSV. 

 

If desired, it is possible to export the results of the QC tracking in the Analysis results CSV. Both the quality control results and QC related notifications on target level can be visualized in the report:

• QualityControlResult
  Outcome of the QC evaluation based on the implemented QC trackings and Westgard rules of control samples. This is indicated as Valid or Invalid. 

• Target_x_QCnotifications
  QC notifications related to Target x (e.g., Warning: Violation of Westgard rule(s) 1:2s)

• ControlValidity
  Both the QualityControlResult (described above) and the control validity of the assigned controls (regular assay target from PCs/NCs in the control results section) are reported. If one of them are invalid, ControlValidity will be reported as ‘invalid’.

Customization of the Analysis results CSV (to include or exclude above parameters) can be done in FastFinder under Settings > Analysis results CSV. As the CSV is exported to the LIMS system, it is important to ensure that any changes made in the CSV are supported by the LIMS platform. It is recommended to contact your local IT department for more information on this topic.

Relevant articles

Settings - Quality control