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Lumira DX

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Lumira DX

The LumiraDx INR Test is a point-of-care test for use with the LumiraDx Instrument - for professional use only

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The LumiraDx Platform is an innovative, next generation point of care diagnostic system that combines a small, portable instrument, advanced low cost test strip and seamless digital connectivity.

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

Smart technology

Its proprietary technology enables it to deliver performance referenced to laboratory standard assays, while being simple and easy to use.

  • Performance referenced to lab tests
  • Portable, seamless connectivity
  • One simple, intuitive test workflow
  • Fast results in minutes
  • All common clinical samples
  • Room Temperature Storage

High-performance features

The highly integrated LumiraDx Test Strip and Instrument interface deliver the following high performance features:

  • Precise sample fluidic control
  • On-strip fluid position sensors
  • Fluorescence or electrochemistry measurement
  • Immunoassay measurement in liquid-free environment
  • System controls cover strip positioning, electronics, optics, temperature, haematocrit and Test Strip expiry
  • Lot Calibration File instant transfer to instrument by RFID tag

Accurate and flexible

  • Use small clinical samples, including capillary blood
  • Can be used to measure a number of parameters
  • Quantitative or qualitative results are compared to standard laboratory reference methods
  • On Board Hematocrit determination integrated into some tests
  • Room temperature storage
  • Liquid quality controls are available