Method Validation for Immucor Echo

[dal6164]

I am trying to write a procedure for method comparison between the ECHO and tube method. I was wondering if anyone out there could share ideas with me or SOPs. Thanks

[David Saikin]

Whatever you are going to do on both - it is just like validating anything. YOu need to select what you are going to validate, how you are going to do it, what you expect the results to be, evaluate your results - if not what you anticipated you will have to figure out why/and what to do next. When you are done and satisfied, you accept your validation and are ready to go live.

[Malcolm Needs ☆]

David is absolutely correct.

The only thing I would add is that you should not expect absolutely the same results with each technique, as no technique will be exactly the same as another in terms of results (although all critical results should be identical to, or better than, the old method.

[AMcCord]

Is this TRM.31450? Comparability of Instrument/Method ? There is a thread on this forum somewhere....from which I pulled a procedure that was shared. Of course right now at this moment, I cannot lay my hands on either the procedure or remember what the thread was called. Basically, what that person was doing, was running 20 (I think) samples for type and antibody screen by tube and by Echo and comparing results. They were also running a number of samples for antibody ID (I think maybe 10) in the same way. This was done twice a year.

I've been using a plasma sample that had a negative antibody screen on Echo for a negative control with daily tube testing QC as part of the answer to this question. To compare blood types, I will use those samples for which we are doing 2 types on patients with no previous history. One type is done by tube and the other type is done on the Echo. That will give us plenty of comparisons for blood types without any difficulty. The next part is to decide how to write all that into my new procedure. I'm still trying to decide how many positive antibody samples to use, whether they have to be different types (Rh, non-Rh, or particular specificities) or are just randomly selected and then how many antibody screens and IDs to run.

If I turn up information on that procedure or thread, I'll post it here.

[bbbirder]

If you are validating the Echo as a new user, Immucor provides a validation guide.

If you are trying to correlate the 2 methods on an on going basis:

Here is the link to that thread:

http://www.bloodbanktalk.com/forum/showthread.php?3366-Trm.31450

Make sure you check out page 2, "method correlation or madness?"

I was thinking of including Suzanne Butch's article as a reference for my BB correlation procedure.

[DPruden]

I attended the (9425-QE) Challenging Compliance Issues from the CAP and CLIA at the AABB conference in October and the take home message was don't go overboard to meet this new requirement. There are still discussions going on at CLIA regarding this item. If you have the sync-to-slide from AABB, I would recommend listening to this one.