POCT PT/INR- Use in the Emergency Departments

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Hello!
Recently, I received a request for POCT PT/INRs- especially with the PTPlus cartidge from Abbott. Our ED is requesting to use the PTplus cartidge on Stroke patients even though that is not what the cartridge is approved for.

What are you using for ED patients and even more specifically stroke patients?

Thank you!

Erin

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At The Guthrie Clinic we use the clinical lab for all PT/INR testing, including stroke patients.  The intended use of the i-STAT PT/INR testing is for the monitoring of warfarin therapy.  It cannot be used as a "screening" device on patients not on warfarin therapy.  You can double check with the manufacturer and your state DOH but it would be off label use to use iSTAT PT/INR on a stroke patient and a regulatory issue.

Karen is correct - this would be off label use and a regulatory issue for sure - we recently had one of facilities cited by CAP for doing this very thing, prompting the removal of the test from the ED.

For the life of me, I do not know why Abbott would not have sought FDA approval for non-Warfarin patients for the new PTPlus cartridges, but here we are.

That cartridge is optimized for monitoring patients on warfarin. It has not been validated as a general screen or even for use in patients on direct oral anticoagulants (DOACs) and heparin for example. What certificate does your ED have. Maybe your lab medical director can let them know that off label use puts the test in a high complexity category. I am sure they don't want the hassle of doing their own validations and meeting high complexity testing requirements.

We utilize the Hemochron Signature Elite devices with the PT Citrated cuvettes to screen patients for stroke in the ED. It is moderate complexity still, and it doesn't compare apples to apples to our lab devices for abnormal patients, but for the target population (normal coagulation) it compares well and is used as a screen upon admission to the ED.

We use the Hemochron Sig Elite for strokes in the ED.  It is run by the pharmacists.

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Erin Jackson
6 months ago
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