iSTAT PT+ cartridge

I would be cautious with the PT cartridge. Last I checked it is only FDA approved to use with patients taking Coumadin only and is not waived

Do you have an Abbott rep to assist you? 
Abbott assigned someone in their tech dept along with their rep to assist us with appropriate data collection.  We compared our old PTINR cartridge to the new PT+ and the main lab's STAGO.

I did reach out to my Abbott rep, but he wasn't super helpful during our initial conversation hence why I am reaching out in here. I am emailing him back asking more questions, but we will see what he provides.

Our rep is fantastic and helps us out a lot. I'm sorry you are having issues. Sometimes you may have to be a bit aggressive requesting help. You are the customer, and if they want you to use the product, they need to be a bit more accommodating. Abbott isn't the only PT instrument in the game. 
I can send you some information on how we performed the validation, but we also compared to our old PTINR cartridge and the lab's STAGO. Since you don't have another in - house analyzer, you may have to compare iSTATs 
to iSTATS. My suggestion would be to contact your inspection agency and speak to one of their
reps (CAP, CMS, etc). They can be very helpful when it comes to doing it 'right'.

Thank you. I agree...I am starting to request more information from him, but anything you can share would be greatly appreciated. 
breana.birmingham@dignityhealth.org

In case you don't have these, below are the following are guides supplied by Abbott that were helpful for our validation.

IQCP guide 2023.pdf

IQCP template 2023.docx

Method Evaluation and the i-STAT PTplus Cartridge NPE-5100-REV1-APOC-EN (v1.1).PDF

PTplus - IFU.PDF

PTplus Controls - IFU.PDF

Thank you so much for these documents. A few of these he provided but a few he did NOT. These are exactly what I needed...this helps a ton! THANK YOU

You're welcome! If you still have questions, let me know. I've never performed a cartridge validation either, but I was lucky and had a lot of help with this one.

In addition to the numerous helpful comments, I also recommend confirming with your middleware provider that your middleware system and/or DE does not require additional configuration, upgrading or patching.