iSTAT current PT and new PT Plus cartridges
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The intended use for PT cartridges is to be tested on patients that are on anticoagulant per IFU. Does anyone use it on non-anticoagulant patients? If you do, would you mind sharing the current processes to ensure you are meeting regulatory compliance? We have CAP, and according to CAP it would be a lab-modified test, which will fall under high complexity requirements. I appreciate your time and input. Thank you!
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It would be a test modification. Just a note about this, though. Obviously there are many tests we could potentially use "off label" and sometimes it makes sense to. For this particular test, however, when working up an off label claim, make sure your pathologist and the providers understand where the measurement is taking place in the coag cascade. It is higher up in the coag cascade, above where fibrinogen is coverted to fibrin. It measures where prothrombin is coverted to thrombin. This is why iSTAT is clear in the IFU that factor deficiencies and fibrinogen related coagulopathies will not be reflected in the INR that you get on the iSTAT. Many want to use this for stroke protocol and that may make sense for you, but if you have it in a FSED or another emergency situation, be sure to consider it's use in other scenarios like a post partum female presenting in DIC. Best, Mary