One component of validating Luminex data is to define a guide set which defines an expected range for the standard for a particular combination of analyte, isotype and conjugate. Each combination may have a different guide set. Once you apply a guide set to a run, the expected ranges are displayed in the Levey-Jennings plots. QC flags will be raised for values outside the given range. Guide sets consist of means and standard deviations for the performance metrics and may be either:

• Run-based: calculated from an uploaded set of runs
• Value-based: defined directly using known values, such as from historical lab data

You can define multiple guide sets of different types and choose which guide set is applied to any given run. For example, you might define a guide set based on a particular lot of analyte, and use it to check performance of that lot over time, then validate a new lot when analyte preparation or supplier has changed.

• Define Guide Sets
• Run-based
• Value-based
• Apply Guide Sets
• Manage Guide Sets
• View QC Flags

Define Guide Sets

Earlier in the Luminex Level II tutorial, we assigned five runs to each lot of analytes, so we can now create different guide sets on this data for each lot of the analyte, one run-based and one value-based. When you later select which guide set to apply, you will be able to see the comment field, so it is good practice to use that comment to provide selection guidance.

Create a Run-based Guide Set

In this tutorial example consisting of just 5 runs per lot, we use the first three runs as a guide set for the first lot. Ordinarily you would use a much larger group of runs (20-30) to establish statistically valid expected ranges for a much larger pool of data.

Notice that the calculated expected ranges are shown applied to the runs you selected as part of the Guide Set. The mean is the average value, the colored bars show the calculated standard deviation. The expected range is three times the standard deviation over or under the mean.

Once you define run-based guide sets for a standard, expected ranges are calculated for all performance metrics (AUC, EC50 5PL and HighMFI), not just EC50 4PL. Switch tabs to see graphed ranges for other metrics.

Create a Value-based Guide Set

If you already have data about expected ranges and want to use these historic standard deviations and means to define your ranges, you create a value-based guide set. Here we supply some known reasonable ranges from our sample data.

Since this guide set is not based on any runs, you will not see expected ranges displayed in the report until it is applied.

Apply Guide Sets

For each run, you can select which guide set to apply. Once a run has a guide set applied, you may switch the association to another guide set, but may not later entirely dissociate the run from all guide sets through the user interface.

Apply Run-based Guide Set

Since we used three of our runs for the first analyte lot, we are only able to apply that guide set to the other two runs from the same lot 437.

Apply Value-based Guide Set

No runs were used to create this set, so we can apply it to all 5 runs that used the second analyte lot.

Notice that three of the runs from the second lot including values within our ranges, but two fall outside them.

Explore the guide sets as displayed in the graphs on the other performance metric tabs for EC50 5PL, AUC, and High MFI.

Manage Guide Sets

You can view the ranges defined by any guide set by selecting View QC Report > view guide sets and clicking Details. Note that for run-based guide sets, only the calculated range values are shown in the popup. Clicking a Graph link will navigate you to the Levey-Jennings plot where the set is defined.

Change Guide Set Associations

Select checkboxes for runs below the Levey-Jennings plot and click Apply Guide Set. You may choose from available guide sets listed. If any selected runs are used to define a run-based guide set, they may not have any guide set applied to them, and requests to do so will be ignored.

Edit Guide Sets

Only the most recently defined guide set is editable. From the Levey-Jennings plot, click Edit next to the guide set to change the values or runs which comprise it. For run based guide sets, use the plus and minus buttons for runs; for value-based guide sets, simply enter new values. Click Save when finished.

Delete Guide Sets

Over time, when new guide sets are created, you may wish to delete obsolete ones. In the case of run-based guide sets, the runs used to define them are not eligible to have other guide set ranges applied to them unless you first delete the guide set they helped define.

When a guide set is deleted, any QC flags raised by the expected range it defined will be deleted as well.

View QC Flags

When guide sets are applied, runs whose values which fall outside expected ranges are automatically flagged for quality control. You can see these tags in the grid at the bottom of the Levey-Jennings page.

• You can also see this in the interactive example.

For additional information about QC flagging, including how to disable individual flags, see Luminex QC Reports and Flags.

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