From Michele Drejka, Newark Beth Israel Medical Center
I have a newly installed PAP-8E, and want to validate its performance. I am planning to run several comparisons with my old PAP-4, but I don’t know what is required or recommended in terms of number and types of comparisons or any other studies that will prove performance.
I am also awaiting info from BioData. I would like to suggest a plan to our director and refer to your advice. Thank you for your help and very interesting website topics.
Hi, Michele, congratulations on your new PAP-8E and thank you for your question and compliment. The document you need for validation is the CLSI Approved Guideline H58A: Platelet Function Testing by Aggregometry, 2008. This is a fairly recent publication, chaired by Doug Christie, PhD, and provides a validation section. Here is the preview page provided on the CLSI web site: H58A Preview. Your QA coordinator should have a copy of the guideline. Geo.