Look Who it Was Random video

EZValidation™ 11: Creating a Custom Guideline

177 views · Published 3 November 2011 · 5:03 · Indexed 10 November 2026

Channel: Thermo Fisher Scientific · 2011 · Education

Watch on YouTube

This video is eleven of 12 that demonstrates the EZValidation Online Tool for validation and verification of molecular tests. It can also be used as training for those unfamiliar with EZValidation and AcroMetrix products by Life Technologies. This video shows you how to create a custom guideline for your study.

Creating a custom guideline in the EZValidation™ online tool. Creating a custom guideline in EZValidation tool is an advanced feature. To look at the guidelines that are applied in the EZValidation™ tool, you would click on the guidelines bar at the top. And this is after you've been logged in. So I'm logged in, I've gone to guidelines, clicked there. And now it's showing me the guidelines. EZValidation tool has standard guidelines that are in the system by default, in this case the ISO 15189 guideline, the CLIA/CAP New York State guideline, as well as calibration verification, a three-by-three HIV verification, and a three-by-three HBV/HCV verification that are used.

But what we can do, if we choose, is to create our own guidelines. How do we choose our own guidelines? Well, first we go to the guideline which we feel is most appropriate or closest to what we want to use. In this case, I'll click on the CLIA/CAP New York State guideline. And what it's showing me is the details of the default CLIA/CAP New York State guideline that is in EZValidation tool as well as some information about it. And down below, it's showing me the parameters, meaning the different studies that are done for a quantitative validation and a quantitative verification.

So these are different in many cases. So for a validation, for example, the accuracy study, while over four days for each requires ten levels of material for a validation versus only five days for a verification. Likewise, an interfering substances study should be performed for a validation of a quantitative assay, but isn't required according to the CLIA/CAP New York State guidelines for verification of a quantitative assay, and so on.

If we were to create our own custom guideline, we would click on "clone". And now it has created a clone, because now it says, copy of CLIA/CAP New York State guideline. I can't make any changes yet until I click on "edit" below. And now it is allowing me to edit this field. So now I'm going to type in clone of CLIA/CAP New York State. I probably would want to erase or modify my description. If I had other authors that I wanted to cite, I could input this information. But most importantly, this allows you to go back into your studies and change these parameters, which will be automatically applied to your data by the EZValidation™ tool.

So, for example, I'll assume that I only need five levels for my accuracy study, and I think I only need to go across three days for validation and three days for verification. Then I would click on update. And now my clone of CLIA/CAP New York state is automatically saved. Where I apply this to a new study is in the first four easy steps. So we'll click on return to all guidelines—actually, I could get there faster if I clicked on home. And I start designing a new study, as I'm still logged in. 

Because it is an advanced feature, you must be logged in to apply your custom guidelines. I would select my location, go down to U.S. And type in an assay name, I would select "clone of CLIA/CAP/ New York State guideline". For test type, I would apply a validation, in this case quantitative. I'll say that this is for adenovirus, copies per mil, plasma to EDTA, click on next to where I can now choose my guideline. And it is going to show me a lot of different guidelines that are in here. And I'll find the clone that I created. And when I click on that, it's going to apply exactly the criteria that I chose for the accuracy, interfering substances, linearity, etc. I'll unclick on normal values. I'll click on next. And now I put in my parameters here. I'll put this at 200 microliters, and I'll click next.

And now the EZValidation™ tool is applying my custom guideline to my study. So instead of the 276 reactions that would typically be required, because I would be doing more extensive accuracy studies, it's only down to 181 studies for this study as I've defined it. Then you could continue to go on by saving study and then filling in your acceptance criteria and all the other information needed for your study before entering your results. But this is how you can create your own guideline and then apply it to the study that you want to create.

http://www.invitrogen.com/site/us/en/home/Products-and-Services/Applications/Diagnostics-Clinical-Research/Quality-Control-Clinical-Labs/Online-Tools-for-Peer-Comparison-and-Assay-Validation.html

More from this channel