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EZValidation™ 3: Setting Acceptance Criteria

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Uploaded on Nov 3, 2011

This video is three 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 set acceptance criteria for your study.

Setting acceptance criteria in the EZValidation™ Online tool. From our study screen, in this case number 280, we're going to set the acceptance criteria. First, we want to verify that all of our study information is correct. This is the validation start date, assay name, laboratory name, created by user, all that we've indicated from our earlier steps, the first four easy steps. Our target analyte is HIV, these are the parameters. So it's a validation of a quantitative assay following the CLIA/CAP New York State guidelines. These are the different studies that we'll be performing.

One thing that you want to make sure is entered, is the instrument ID number for your extraction system; in this case it's the Roche COBAS AmpliPrep instrument. The amplification system is the Roche COBAS TaqMan test. And it's entered in here. Type in the number, and select enter. Now the acceptance criteria for the verification or validation study will be set up using default settings from selected guidelines or from user-defined criteria, which is down below in the parameters, acceptance criteria, and result section. Displayed here is the accuracy study.

As we've mentioned earlier, the menus are dropdown-menu driven. So in this case, we would click here for sample ID 1E2 and choose our acceptance criteria. We can choose this for every one of our levels of sample. Here you'll see that the expected result, which should be automatically populated by the EZValidation™ tool if you're using the AcroMetrix® products, is all filled in this column, the log expected result as well. The observed results - these are in for demonstration purposes, because we've already entered those in. But for your purposes, in this step, these will not be listed until after you've had them input either manually or using an Excel spreadsheet.

And then you can see that validation has automatically been determined based on the selected acceptance criteria, whether the results have passed or failed the criteria. If there's any change to be made in the acceptance criteria, or when you're initially entering criteria, always press on save accuracy criteria. And likewise, as you scroll down, the interfering substances study, which we do for a validation but wouldn't typically do for a verification, you would enter this. Again, it's dropdown-menu driven. Click on save.

Likewise, in this study, we're performing linearity. You would enter your acceptance criteria of slope, intercept, and R-squared value. Again, remember to click on the save linearity criteria. The limit of detection, this was automatically chosen in the first four easy steps. And it automatically calculates an estimated 95% of LOD and confidence interval once all of the data has been entered. But here, all of the data has not been entered, so it hasn't been calculated.

The repeatability study, again, drop-down menu driven. You can choose a different level for each one of your samples. And in this case, we have chosen a higher CV for the high positive control. And lastly, the reproducibility. Same thing, dropdown-menu driven, and you can have different levels for each one of your controls.

http://www.invitrogen.com/site/us/en/...

The EZValidation™ Online Tool is a web-based program intended to assist laboratories meet their verification or validation requirements. Laboratories are responsible for ensuring compliance with applicable international, national and local clinical laboratory regulations and specific accreditation requirements.

©2011 Life Technologies Corporation. All rights reserved. The trademarks mentioned herein are the property of Life Technologies Corporation and/or its affiliate(s) or their respective owners.

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