INR Test

Intended Use

  • The LumiraDx INR Test is a point-of-care test for use with the LumiraDx Instrument
    - for professional use only
  • Measures quantitative prothrombin time, reported as International Normalised Ratio (INR)
  • Used for the monitoring of oral anticoagulation therapy with vitamin K antagonist (VKA) drugs
  • Assay has not been validated for individuals younger than 18 years old

Test Description

  • Thrombin activation assay - the coagulation cascade is activated by the test reagents and INR is calculated from the measured PT-time
  • Emitting fluorescence is detected at a threshold point and time to reach this is measured
  • Haematocrit is also determined on the strip to ensure patients are within the 25-55% range
  • Results compared to the Instrumentation Laboratory ACL Elite lab reference method

Built-in Quality Controls

Instrument and Test Strips are highly integrated and have several quality control functions. The Instrument contains a number of automated checks of the correct functioning of the Instrument at power on and during operation.

INR Quality Controls

Quality Controls are available from LumiraDx and are intended for liquid quality control testing performed on the Instrument when used with the INR Test Strip.

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