i-STAT PT/INR for Trauma Patients
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Hello,
I am wondering if anyone has performed a validation study to perform the i-STAT PT/INR test for trauma patients which would make it high complexity/FDA modified LDT. If so, if you could please share your validation plan that would be much appreciated. Our trauma doctors are insisting that it is used throughout the country off-label for this type of patient population but I have not personally spoken with a system that has performed an LDT validation for this test.
Thanks for any insight!
I am wondering if anyone has performed a validation study to perform the i-STAT PT/INR test for trauma patients which would make it high complexity/FDA modified LDT. If so, if you could please share your validation plan that would be much appreciated. Our trauma doctors are insisting that it is used throughout the country off-label for this type of patient population but I have not personally spoken with a system that has performed an LDT validation for this test.
Thanks for any insight!
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