Signature Elite PT/INR
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Please excuse my question, I am new to Point of Care, so this may seem silly. My institution performs POCT PT/INR testing on the IL Signature Elites. I am unable to find information on linearity and method comparison CAP requirements. Our laboratory using the Stago. Can someone please provide me some insight. I have spent hours researching this. I know there is an exception for calculated results, but what about the PT?
Thank you
Melissa
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“COM.04250
Comparability of Instruments and Methods - Nonwaived Testing” is the regulation I would refer to for comparisons. And COM.40600 refers to AMR and states that some Coagulation testing doesn’t require this.
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We use the Signature Elite for ACT (Activated Clotting Times) testing and as per the manufacturer, there is no Linearity that can be done on the devices. As for instrument to instrument comparison, we use CAP quality cross check material (CT2Q) to do those comparisons. Based on literature we've seen, due to the nature of coagulation testing, there is no true method to method comparison.