Making Own Kleihauer Reagents

[AB123]

In our part of the world we are unable to purchase any commercially available Kleihauer reagents/kits, we have started making our own from the base chemicals following the method described in the AABB test method guide. 

I'm assuming this would constitute a LDT under CAP? in this case for validation and QC purposes what would we have to do in addition to the usual test method validation and QC's with every batch? if anything.

Just to clarify, we are making up the Citrate phosphate buffer and the Eosin solution, the Hematoxylin is a commercially supplied.

 

TIA

Edited February 4, 2023 by AB123