Reagent validation study help

[Skinrash]

I'm seeking some assistance in setting up our reagent validation study. We are switching our tube reagents Anti-A, Anti-B, and Anti-D only from one manufacturer to another. What all is required in this validation study? If anyone has a spreadsheet or template I could use, that would be greatly appreciated if you're willing to share.

Thanks!

[Likewine99]

I test 25 samples using both methodologies. Make a spredsheet with 3 columns for your 3 "old" reagents then 3 more columns for your 3 new reagents next to it.

Enter your pt id, enter your results from the old reagents in the first 3 columns, then results from the 3 new reagents.

Set your tolerance limits, compare final results, determine acceptability, done!

[NedB]

QED. No more need be said, except that I would note in the procedure that discrepant results would be vigorously investigated.

[dmpollock]

Since you are validating blood typing reagents, the easiest way, without doing any extra testing at all, would be to start using them at the same time as the old ones.

During the validation period:

If the sample is from a new patient with no historical blood type, test with the old reagents.

If the sample is from a patient with a historical blood type, test with the new reagents. If the results match, then your new reagent is working.

By the time you run out of old reagents you should have plenty of data.

You would of course have to QC both set of reagents daily if you use this approach.

[Fluffy agglutinates]

This is what we use in the UK...

http://www.transfusionguidelines.org.uk/Index.aspx?Publication=RB&Section=25&pageid=646

[Skinrash]

Thanks again for everyone's help. I can once again know that I can count on my fellow blood bankers to help out. I've started the validation study and don't expect it to take very long at all. I don't know why I was stressing over such a simple change.

thanks everyone!