Validation study for modified cells

[JerryB]

I've noted many are using Immucor screening cells quite often, for a myriad of reasons, when encountering issues wiith Ortho screening cells. Recently we decided to use Immucor screening cells as a "back-up" to the 0.8% Ortho screening cells. Since we must modify the Immucor cells to 0.8%, should we perform validation studies on the modified cells to assure their reactivity is still within the acceptable limits specified by Ortho since we are using Otho's Confidence Antibody to perform day-of-use quality controls on these modified cells?

[Malcolm Needs ☆]

I don't know for certain of course, but I think you could be laying yourself open to trouble if anything went wrong and you had not performed a validation. Even if you think it is paying lip-service, better that than paying massive dollars in compensation if you cannot provide evidence of work done to prove that they work, prior to introduction.

[L106]

Once again, though, this scenario brings up the question whether "extensive validation" or "daily QC" is adequate???

[Malcolm Needs ☆]

In this case, I would have thought daily QC would be quite adequate.

[David Saikin]

I use 2 different manufacturer's ab panels besides the Ortho B. I have "validated" them by running abid's with then neat (3-4%) and in gel (0/8%). Had to make certain I was getting the same results. I used frozen patient antibodies, not commercial. I think you do need to perform validation, but you can determine how much you need to do (don't let some inspector tell you that you didn't do enough - there is no set formula you have to adhere to).

[Malcolm Needs ☆]

I use 2 different manufacturer's ab panels besides the Ortho B. I have "validated" them by running abid's with then neat (3-4%) and in gel (0/8%). Had to make certain I was getting the same results. I used frozen patient antibodies, not commercial. I think you do need to perform validation, but you can determine how much you need to do (don't let some inspector tell you that you didn't do enough - there is no set formula you have to adhere to).

I like your method David and, oh boy, do I agree with your last statement!

[Eagle Eye]

CAP has new question regarding method correlation..in other words if you are routinely using Gel, tube and ProVue/Echo, you must run samples (twice a year) to prove correlation between different technique.

Chemistry had this question all the time but now it is on Transfusion Medicine checklist.