The Coag-Sense Prothrombin Time (PT)/INR System is used for quantitative measurement of Prothrombin Time (PT) in fresh, capillary whole blood. The Coag-Sense PT/INR system is intended for use outside the body (in vitro diagnostic use) to test patients taking warfarin-type oral anticoagulant (blood thinning) therapy who need to monitor clotting time.
The meter performs a self-test when it is first turned on. If there are any problems with the meter, an error message is shown on the display. Refer to the Troubleshooting section of this manual or contact Technical Support.
A test strip is inserted and heated in the meter prior to sample application. The strip contains a tiny wheel with spokes that pull the sample into the reaction well. The spokes quickly and completely mix the sample with the clot initiating component of the test strip.
The PT time is determined from when (a) the sample is drawn into the reaction well of the test strip and detected by a beam of light until (b) a clot forms and interrupts the beam of light. The PT result is converted to an INR (International Normalized Ratio) using the calibration data stored in the meter. INR is a mathematical correction of the PT result that adjusts for sensitivity differences among different PT systems.
The meter continues to check every feature of its operation through a series of self-checks.