App Updates

App Updates

March 28th 2025

The team has been hard at work adding features fixes and changes by request! We made MVs more robust and intuitive. Here are some highlights:

Feature: Method Comparison and Linearity Allow for 6 different Regression Measurements

In experiment settings you may now select the type of regression analysis for your acceptance criterias. This allows for more advanced testing or when your analytical methods have an expected difference making Allowable Error testing inapplicable to the performance evaluation. See Quantitative Linearity and Quantitative Method Comparison for more information.

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You may choose from the following regression types:

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**Cualia Support Docs Definitions (Public)**

Name
Definition
Deming Variance Ratio (vr)

Quantifies the agreement between two measurement methods, considering measurement errors. A maximum allowable difference from 1 is standard. VR=Var(X)+Var(Y)Var(XY)VR = \frac{Var(X) + Var(Y)}{Var(X - Y)} Var(X)Var(X) = Variance of X Var(Y)Var(Y) = Variance of Y

Passing Bablok Correlation Coefficient (r)

Measures the strength and direction of the linear relationship between two measurement methods using Passing Bablok regression. A minimum absolute value of 0.95 is standard for strong correlation. r=Cov(X,Y)Var(X)+Var(Y)r = \frac{Cov(X, Y)}{Var(X) + Var(Y)} Cov(X,Y)Cov(X, Y) = Covariance of X and Y Var(X)Var(X) = Variance of X Var(Y)Var(Y) = Variance of Y

Pearson Correlation Coefficient (r)

Measures the strength and direction of a linear relationship between two variables. A minimum absolute value of 0.95 is standard for strong correlation. r=Cov(X,Y)σXσYr = \frac{Cov(X, Y)}{\sigma_X \sigma_Y} Cov(X,Y)Cov(X, Y) = Covariance of X and Y σXσ_X = Standard Deviation of X σYσ_Y = Standard Deviation of Y Cov(X,Y)=1n1i=1n(xixˉ)(yiyˉ)Cov(X, Y) = \frac{1}{n-1} \sum_{i=1}^{n} (x_i - \bar{x})(y_i - \bar{y}) nn = Number of data points xix_i = Individual data point of variable XyiXy_i = Individual data point of variable Y xˉ\bar{x} = Mean of variable X yˉ\bar{y} = Mean of variable Y

R-squared () Coefficient

R-squared is a statistical measure that represents the proportion of the variance in the dependent variable that is explained by the independent variables in a regression model. It ranges from 0 to 1, with higher values indicating a better fit. Usually >0.95 is considered statistical correlation. R2=1i=1n(yiy^i)2i=1n(yiyˉ)2R^2 = 1 - \frac{\sum_{i=1}^{n} (y_i - \hat{y}i)^2}{\sum{i=1}^{n} (y_i - \bar{y})^2} R2R^2 = Coefficient of determination yiy_i = Observed value y^i\hat{y}_i= Predicted value yˉ\bar{y} = Mean of observed values nn = Sample size

Sample Correlation Coefficient (R)

The sample correlation coefficient (R) quantifies the strength and direction of the linear relationship between two variables based on sample data. A min value of 0.95 is standard. R=r2R = \sqrt{r^2} r2r^2 = Coefficient of Determination

Spearman Rank Correlation Coefficient (p)

Measures the strength and direction of a monotonic relationship between two variables. A minimum absolute value of 0.95 is standard for strong correlation. p=16di2n(n21)p = 1 - \frac{6 \sum d_i^2}{n(n^2 - 1)} did_i= Difference between ranks of X and Y nn = Number of pairs

Feature: Trueness Experiment Range Mode

In Quantitative MV Trueness Experiments you can now select a Range Mode to match your EQA testing ranges. To use Range Mode select Experiment Settings and switch to Range Mode. In this mode there will be a minimum and maximum value column. Your measurement must be between these values in order for it to be considered in agreement. The Bias column uses the mean of the min and max to calculate the bias.

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Change: Bias Column added to Quantitive Linearity Experiments

In order to better detect systemic and random error in MVs, we added bias column to Quantitative Linearity experiments.

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Feature: Bias and Percentage Bias Charts added to Method Comparison and Linearity

We found that charts give a lot of insight into random error and systemic error like shifts. Quantitative Method Comparison and Linearity Experiments now include Bias charts to highlight any errors in performance in just a glance.

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All of the Changes:

**CUAL UPDATES**

New Features
What was updated
Description
EXPERIMENTAL Copy Pasting Smart Content in MV Summaries

This is an experimental feature. Currently smart content is a very powerful tool with a lot of complexity. We have started early implementations to make it possible to copy paste sections and tables with smart content to other summaries to function more like normal word processing.

MV Export for All of the Same Experiment Type

We added a feature in MVs to export all of one specific experiment type. For example you can export all the Linearity Experiments within an MV. This can be useful if you have an auditor who prefers viewing MVs by experiment-type instead of by test.

In Quantitative Method Comparison and Linearity experiments the type of regression may be selected with specific cutoffs for more advanced analysis. Additional to this, each regression is displayed with any results available as part of the analysis.

Links to Documentation

In MV Experiments and PDF exports, links to documentation have been added to help find information on how to run the evaluations and reference the equations used in Cualia calculations.

More Charts in Method Comparison and Linearity

Bias and Bias % charts were added to Linearity and Method Comparison tests. This allows for better insight into how the performance of the evaluation proceeded highlighting any systemic errors and shifts.

In Quantitative MV Trueness Experiments you can now select a Range Mode to match your EQA testing ranges.

New Test Templates in MV Reports

In the tests sections of MV Reports you can generate a table for each test each experiment status.

Changes
What was updated
Description
New Default MV Experiment Values

MV Default values were added if they were not pre-set Quantitative Precision (CV Mode): CV %: 2.5 Quantitative Accuracy (TEa Mode): Reference Value: 2.5 Quantitative Linearity (Reference Values): Reference Values: Rounded to 2 decimals. Quantitative Carryover (Percent Mode): Allowable Percent: 10% Quantitative Carryover (Standard Deviation Mode): Allowable Standard Deviation: 1 Quantitative Limit of Blank (LoB): LoB Reference Value: 0.05 Quantitative Limit of Quantitation (LoQ): LoQ Reference Value: 0.1 Qualitative Limit of Detection (LoD): Minimum Detectable Concentration: 1

Chart dot sizes reduced

Size of the dots in our charts were reduced by 30%. This makes the specific areas of the graph more readable when there are more data points.

Documentation links added to experiments

MV Experiments now have a link to relevant documentation on web and PDF exports. This allows a quick reference for how to perform the evaluation in Cualia, set Acceptance Criteria, see all the definitions and equations used in the calculations.

Experiment Summary Character Limit Increased to 1500

The experiment summary text area will now allow up to 1500 characters. However due to spacing requirements, summaries will appear on its own page of PDF exports.

MV Reports Button Will Not Open a New Page

The MV Reports Button will default to keeping you within the window you’re using. An open in new window icon is on the left if you wish to continue checking your reports in a separate window.

MAJOR: Bias Calculation was flipped

There has been a lot of confusion about which is the result of your instrument and which is the reference. X and Y, actual expected, actual and reference. In the future we will switch to “Measurement” and “Reference.” The Bias Calculation has now been flipped to be Actual - Reference to show correct positive and negative bias. The charts will reflect this change as well.

Bias Column was added to Quantitative Linearity tests. This gives a sense of where the mean replicate measurements were compared to the reference value.

More tooltip explanations

Tooltips for equations were added to the Quantitative and Qualitative MV Experiments. This was a heavily requested feature to give more clarity to our users for what was on the page without making the UI overwhelming.

References section removed from reports.

Removed "References" from the default Conclusions section in reports for clarity. You may still add a reference section, but it is no longer a default Report section.

Fixes
What was updated
Description
Fixed empty last modified cell issue.

Fixed an issue where sometimes in the Verifications list that the last modified field would sometimes be empty.

Made experiment table checkboxes easier to click.

Experiment table checkboxes were sometimes difficult to click, requiring precise positions or double clicking. We’ve made it more intuitive.

Changed “R” to “r” for clarity.

For consistency, all regression values displayed with capital R have been changed to r.

Made it easier to select the MV Evaluator.

There was a bug in MV’s when selecting the evaluator personnel that it would disappear. This has been resolved.

Resolved HTML symbol occurrences when copying in reports.

Fixed an issue where the MV Evaluator (person performing the MV Evaluation) was difficult to select.

Corrected completion percentages for SMQ tests.

Regression values were sometimes labeled as “R” instead of “r.” This was fixed in the new release to decrease confusion.

Added missing yellow check icon for incorrect results in SMQ and Qualitative modes.

Experiment table checkboxes are now easier to click. Before it would sometimes require a double click to select the cell. Now we made it easier by expanding the area that would register a selection.

Fixed inconsistencies with Force Pass in Method Comparison experiments.

Fixed a bug in Verifications list where the last modified cell would sometimes be empty

Resolved icon positioning issue after redo button click.

Fixed an issue when copy pasting in reports that some HTML symbols would occur

Ensured header/footer displays on the first page when toggles are off.

Fixed an issue in PDF Export settings so that when Show Header or Footer on all pages was unset that it would still be displayed on the first page. Renamed “Include Sample Results” to “Include Sample Data”

Renamed “Include Sample Results” to “Include Sample Data.”

Updated error message logic in the Test Definition Interference section to reduce uneccessary error notifications.

Reduced unnecessary notifications in Test Definition Interference.

Fixed validation error in Test Definitions preventing test saving when Range Low was less than Range High.

Resolved issue preventing test saving when Range Low was less than Range High.

Fixed an issue where leftside menu tooltips were sometimes being cut off.

Addressed cut-off tooltips in the left-side menu.

Fixed an issue where the select experiment header in MVs would show up twice.

Fixed select experiment header appearing twice in MVs.

Fixed and issue where analyte options would display even when there was already one selected.

Resolved issue of analyte options displaying when one was already selected.

Fixed up some of the equations in Carryover to display the equation on the tooltips. The documentation at https://docs.cualia.io has been updated to reflect these as well. Before the Carryover would use the means of the high and low concentration values. It now only uses the first and last to calculate carryover.

Changed calculation to use only first and last values instead of means.

Fixed the icon positioning issue after clicking the redo button. Fixed inconsistent undo/redo functionality when using Force Pass in Method Comparison experiments.

Improved display of equations in Carryover tooltips.

Fixed missing yellow check icon for incorrect daily run results in SMQ and Qualitative modes.

Updated Carryover calculation details on the documentation site.

Fixed the progress indicator for SMQ tests to display accurate completion percentages.

December 18th 2024

We’re excited to announce several new MV features!

Method Comparison by Regression

In cases where a lab must do an MV focused on correlation, such as a reagent change causes a shift in results or a validated version of the same instrumentation cannot be found, using an R-Squared regression standard might be the right way to go.

Cualia MV experiments for Quantitative Method Comparison experiments now allow R-Squared(r²) regression as the acceptance criteria. To do this use the experiment settings and select Regression mode as the acceptance criteria. From there you can set your minimum R-Squared value required to pass the experiment.

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Force Pass Samples

Applies to MV Experiments: Method Comparison and Trueness

There are cases when force passing a sample is important for MV validity due to instrument limitations, non-clinical relevance or methodological investigations such as testing out of instrumentation range.

To force pass a an eligible sample (must have an actual and reference) value, double click the green or red pass fail icon. The sample will pass and the icon will turn a lighter shade of green to indicate it was force-passed without it being visually obtrusive.

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**CUAL UPDATES**

Changes
What was updated
Description
Analyzer test name alignment

In the analyzer’s list of quant, qual and semi-quantitative tests, the alignment of the name was fixed to be more readable.

“Source” column header has been renamed to “Comment”

In the MV Method Comparison and Trueness experiment table headers, the “Source” column header was renamed to “Comment”. This was to help provide flexibility to put whatever supplementary information is required such as source, date, operator or general commentary.

Test units on MV PDF exports

The test’s units were added to each header of the PDF exports as a reference for viewers.

MV report default header and footer values

Whenever you start a new MV without a template, the defaults will be set to the reports: Header Title: Analyzer Information Header Subtitle: Department Name Footer Line 1: Evaluator Footer Line 2: Date the MV Started

Go to Analyzer button added

When in an MV, the Analyzer name in left side navigation now has a button to return to the analyzer.

Analyte dropdown sorting

When creating or editing a test, the analyte selection dropdown is now in alphabetical order.

New Features
What was updated
Description
Regression Acceptance Criterias for Method Comparison

Result Types: Quantitative MV Experiments: Method Comparison In Quantitative Method Comparisons, an option to use R-Squared Linear Regression values as the acceptance criteria has been added. Use the Experiment Settings to switch to R-Squared regression as the acceptance criteria. You will be able to set a min. R-Squared value required to meet experiment requirements.

MV result Force Pass

Result Types: Qualitative and Quantitative MV Experiments: Method Comparison and Trueness A double click action on the green checkmark (eligible samples only) will set the result to pass regardless of the Error Index. This facilitates many tests where values in specific ranges do not follow the requirements around other ranges. The green ✅  checkmark will turn a lighter shade of green to indicate that it is force-passed without a strong negative aesthetic.

MV Report “Go to MV”

A return to MV button was added to the reports page to make it easier to return to the workspace.

MV PDF export filenames

In MV Previews, selecting the export to PDF button will download the PDF with a set naming convention to match what is being viewed on the PDF preview.

Fixes
What was updated
Description
MV sharing by email submission

A fix was made where the MV sharing mechanism for email input would stay within the text box even after submission.

CTAs on Department forms

Add and Edit Department action buttons have been changed to “Add Department” and “Save.”

Linearity PDF line chart added

Fixed an issue where the linearity chart was missing in PDF exports.

Email case sensitivity

Share and invitation emails will no longer be case sensitive. This was causing invitations to not be sent.

Deleted tests appearing

Fixed a bug where a deleted tests would still show up in the analyzer for a few minutes.