Non-blood testing on iSTAT
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Hello everyone,
I am about to venture into something unique that has not been done before to my knowledge. Our transplant and perfusion team has approached us to help them validate CG8 & CG4 cartridges on the iSTAT for liver bile while in the liver is in between bodies!! They will be checking the viability of the organ for Glucose, lactate, and pH. The interesting part is that there is no FDA, CAP nor CLIA guidelines on this matter.
So my question is... help me write up a validation plan?
Obviously it will be iSTAT vs Alinity ci, but my director mentioned doing the correlation against a third instrument as well (preferably POC) which for us it'll be GEM 7000s, but my GEM is not validated for lactate itself.
It took 3.5 mo for my request from a reference lab to be able to send me 23 tubes of bile with enough volume for me to test against 3 instruments. I'm mentioning this because i wont have room for error with very limited sample pool so i wanted to get your take on how I should put together a validation plan and to execute it.
thank you
I am about to venture into something unique that has not been done before to my knowledge. Our transplant and perfusion team has approached us to help them validate CG8 & CG4 cartridges on the iSTAT for liver bile while in the liver is in between bodies!! They will be checking the viability of the organ for Glucose, lactate, and pH. The interesting part is that there is no FDA, CAP nor CLIA guidelines on this matter.
So my question is... help me write up a validation plan?
Obviously it will be iSTAT vs Alinity ci, but my director mentioned doing the correlation against a third instrument as well (preferably POC) which for us it'll be GEM 7000s, but my GEM is not validated for lactate itself.
It took 3.5 mo for my request from a reference lab to be able to send me 23 tubes of bile with enough volume for me to test against 3 instruments. I'm mentioning this because i wont have room for error with very limited sample pool so i wanted to get your take on how I should put together a validation plan and to execute it.
thank you
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Has your transplant and perfusion team investigated through their professional circles, societies, professional organizations, this challenge they are pushing out to you/your lab team?
Your venture may not be as unique a one as has been presented by transplant and perfusion.
Checking for viability of transplanted organs and checking for successful perfusion of the organ 'between bodies' is not a unique concept by a long shot; perhaps any transplant team and lab supporting a transplant team may have published only in limited scope and not in 'clinical laboratory' related journals (as stated, this is not a CLIA regulated 'specimen').
Wishing you success in this journey.