While addressing the validation needs of our users, we’ve implemented six different comparison studies to Validation Manager. How to choose which one fits your needs best? Here’s a small guide to current seasons comparison study collection in Validation Manager.
Are you into qualitative or quantitative?
- If you want information about how accurately your samples are interpreted as positive or negative, your choice is qualitative.
- If you want to compare quantitative values, whether stated concentrations or some other numerical value derived from the detected signal, you should go for quantitative.
What are you comparing?
The main reason why there are so many comparison studies is that there are surprisingly many things that can be compared! The result of a test depends on many different things that can vary during the workflow of testing a sample. So, to start a comparison study, you first need to know which of the many variables you are actually examining.
1. Comparing sample extraction methods?
In molecular diagnostics it is typical that the sample needs to be processed in order to get it ready for the test. Some detection instruments do it by themselves as part of their internal workflow. For other instruments, you may need a separate step for sample extraction. In the latter case, if you want to compare two or more extraction methods, Sample Extraction Method Comparison study is your choice! At the moment, it’s only available on our qualitative collection.
2. Comparing test methods?
For example, if you are comparing influenza tests from different manufacturers, how concordant results they produce, these are your choices:
- For qualitative studies, there are two options. Method Comparison study is for comparing a method to one other method. If you have more than one analytes on your test, you can choose the comparison method individually for each of the analytes. If you want to gain more information by comparing your validated test to a set of methods that together form a diagnostic accuracy criteria, you should choose the Diagnostic Accuracy study that enables making multiple comparisons for each analyte.
- For quantitative studies, we have Measurement Procedure Comparison study. You can form comparison pairs to as many methods as needed. With the help of Validation Manager project report you can easily get summarized comparison results for each analyte.
3. Comparing the instruments used to run tests?
Basically, if the stuff that you are mixing with the samples comes from the same bottles for all instruments, you are doing an instrument comparison study. If the bottles have different labels on them, you are comparing test methods and you should return to option 2.
- For qualitative studies, we have Qualitative Instrument Comparison study.
- For quantitative studies, we have Instrument Comparison study. It was here first so it has the privilege of holding a shorter name.
Still feeling a little confused?
The key to meaningful validations is understanding what you are validating and why. We understand that sometimes it can be challenging to choose the right comparison study type, and that there may be comparison needs that are not yet met perfectly. We are currently planning how to make comparisons easier and more versatile to better serve your purposes. By sharing your needs with us you can help us make Validation Manager even better.