Control materials tracking in Clarity

[gelli]

About control materials (not calibrators), it could be useful to implement their tracking in the software (e.g. having the control materials being stated as Low Control and High Control in the sequence worklist and having their low/high range limits stored in the method, so that the end user can validate each analytical run just by verifying that the controls in the run do not excedeed those limits).

[Daniel Mentlik]

Dear Gianluca,
can you please go into more details? I am quite not sure what exactly you would like to achieve, as Low Control and High Control does not ring a familiar note.

Thank you,
Daniel

[gelli]

In a clinical environment, after creating a calibration curve, users verify the calibration of the method by running (usually) a couple of control materials, a "low" one (LC, under the cutoff) and a high one (HC, over the cutoff).
These control materials are certified ones (lot nr. , expiry date...) with an average, desirable, value and a range of acceptability (eg. epinephrine high control: 100umol/L with an acceptability range from 92 to 108 umol/L). It would be nice to have at least the range of acceptability, for example as a column in the calibration table and having, in the sequence table, the possibility to set a sample as LC or HC. Should Clarity be also capable of checking the LC and HC result and warning the user when the result for any of them is out of the acceptability range, would be a strong plus.

[Daniel Mentlik]

Dear Gianluca,
OK, now I understand. The desired behavior is in fact available in Clarity including the reaction on failed/passed test by using the SST Extension. How to set up the experiment:
On a chromatogram of such High Control standard, create a SST method in the Chromatogram window using the

• SST - SST Result (to display the SST tab)
• SST - New (to create a new SST method)
• SST - Update from Calib (to load the list of peaks from a calibration file)

the screen will look similar to this:

As a second step, fill in the necessary parameters for the control. Let us say my Tetrachlormethane peak is the one used for High Control, Expected Amount is 1.2, lower limit is 1.1, upper limit 1.3.

• Select the checkbox of the Tetrachlormethane in the table on the left
• Double-click the Amount Column in the table on the right to activate it
• Set the 1.1 value in the Lower Limit cell of the column, 1.3 into the Upper Limit cell.
• Right-click the table and select the SubParameters item. On it, switch to the Each Individual Value item and uncheck the %RSD Limit item (as you do not need it)
• You may hide the inactive rows and columns by using the SST - Show All Columns and SST - Show All Rows items in the menu

You will see similar result now:

The result of the check is displayed by the green tick mark or red cross. You can validate several different parameters at the same time this way. Now let us set up the behavior for failing the test:

• Use the SST - Events command to open the dialog again.
• Set the tab as on next picture:

You can trigger any external program you want, set different events on failed check or passed check etc. Save the created method by using the SST - Save item (I used HighControl.sst file name). You can create the low control SST method in the same manner.

To set up run to be checked by the SST method, set the sequence accordingly:

• Right-click the sequence table and select the Setup Columns item
• Set the columns Open, Run Program, Program to Run, Parameters and Include in SST as visible (should be on the right side list)
• set the columns for the rows with High Control and Low Control samples as shown on the next picture:

This will force Clarity to open the correct SST method for the row and perform the check. The check results can be moreover printed, the SST prints are set on the Report Setup - SST tab.

Would this procedure work for you?

[gelli]

Hi Daniel, thank you.
Yes, the SST could be a workaround to have a quality control check on runs. We must think about including it in our offers to the customers, though, since it will be an additional cost....