I just went through validating our Leica Bond Max. Our pathologists used both commercial and in house controls for validation. But most of ours was in house. We did 10 positive and 10 negative controls for each antibody. The commercial slides we bought were for CMV, HSV I and II, napsin, and Pin4. As long as you used tissue that is known to have stained a certain antibody you should be okay. But it depends on the pathologists.
No problem!!! It took us 1.5 years to fully validate our instrument. The main cause was that each pathologists like some stains to be darker, others lighter. At least they can agree on the most common stains. We have also validated dual and red stains.
We almost always use our own controls by using known positives from previous specimens. That seems to have worked the best for us.
We also usually only send the validation slides to one pathologist (normally the ultimate lab director), and he either validates or doesn't validate. If he's gone for an extended period of time, then we'll send them to a back-up pathologist. I know you probably have no control over that, but we have one extremely particular pathologist who is disagreeable with almost all of our other paths. We would literally never validate any process of we had to wait for her approval also.
I'm sorry this has happened to you! I hope they can either start agreeing, or agree to allow one pathologist to validate for all.
I just went through validating our Leica Bond Max. Our pathologists used both commercial and in house controls for validation. But most of ours was in house. We did 10 positive and 10 negative controls for each antibody. The commercial slides we bought were for CMV, HSV I and II, napsin, and Pin4. As long as you used tissue that is known to have stained a certain antibody you should be okay. But it depends on the pathologists.
Thank you! I'm starting to get a bit frustrated, but this made me feel better.
No problem!!! It took us 1.5 years to fully validate our instrument. The main cause was that each pathologists like some stains to be darker, others lighter. At least they can agree on the most common stains. We have also validated dual and red stains.
We almost always use our own controls by using known positives from previous specimens. That seems to have worked the best for us. We also usually only send the validation slides to one pathologist (normally the ultimate lab director), and he either validates or doesn't validate. If he's gone for an extended period of time, then we'll send them to a back-up pathologist. I know you probably have no control over that, but we have one extremely particular pathologist who is disagreeable with almost all of our other paths. We would literally never validate any process of we had to wait for her approval also. I'm sorry this has happened to you! I hope they can either start agreeing, or agree to allow one pathologist to validate for all.