i-STAT ACT validation

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Most of our hospitals use the Hemochron for ACT, but one of them is bringing in a contract group to do cardiac caths, and they want to use the i-STAT. For those using i-STAT, how did you validate the test? We don't currently have any ACT testing at this site, so won't be comparing the i-STAT to another method. Thanks in advance for any advice!

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Abbott provided a guide for our validation studies for i-STAT ACT, which included precision studies, correlation studies (with Medtronic ACT Plus that we had) and a normal range study.  They also provided training material for our staff.

Thanks Jane. I've reached out to Abbott.

Hi.  I can send you my validation study as the CATH Lab switched from the Hemochron to the i STAT for ACT testing.

CLSI POCT14-ED2.2020 Point of Care Coagulation Testing and Anticoagulation Monitoring 2nd Edition is helpful as well!

That would be great, Cathy! My email is kathleen.david@tricore.org.

We switched from Hemochrons  to I-stats  a year ago with our merger . I was super busy with that so I asked my Abbott rep for help .They sent someone to do the validation of the new meters  and help with training. I have done validations myself before and Abbott has  a great guide that tells you what to do also.
PV Protocol Chemistries, Blood Gases and Hematocrit April 2020 (2).pdf

Kathleen, we use the ACT Kaolin cartridge.

Thanks Kimberly! 
Cathy, we will be using the kaolin cartridge as well.

Our Cath lab switched from hemochron to i-stat and Cath doctors feel like the i-stat is not accurate because they are giving more heparin to reach their target. I predicted a shift and curious how other hospitals eased the minds of cath staff with the shift in ACT. They knew there would be a shift but they believe it is a concerning shift. 

We had the same issues Jennifer.  We provided our Cath docs with the data from the validation but they needed to "see for themselves" so we allowed a short internal study where they were able to run the sample on the iSTAT and the Hemochron simultaneously.  The Hemochron results were not charted but were recorded as part of the study.  I recommend working with your patholgists and lab directors to determine what target ranges they were using previously with the Hemochron and use the validation data to help them adjust those ranges to align with the iSTAT performance.  We also ran into this issue with our Neuro IR doctors.  In that case, they requested an additional internal study and in that situation we also had blue tops drawn and ran anti-Xas as part of the study to show therapeutic heparin levels at the suggested target ranges for the iSTAT.  Long story short, transitions in ACT methodology are far from easy. Utilize your pathologists and your data.  

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Kathleen David
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