LumiraDx INR Test
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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. This includes: • Electrical component operation, heater operation, battery charge state, mechanical actuators and sensors and optical system performance • Test Strip positioning, optics, hematocrit and Test Strip expiry • Monitoring of Test Strip performance and controls during test runtime 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 These checks are included to ensure that: • The behaviour of the sample moving into the reaction area of the Test Strip is as expected • The Test Strip has not previously been used • Blood samples outside the accepted hematocrit range are identified 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 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. Direct Capillary Blood (596 samples from 326 patients) was collected from multiple sites. Reference method was ACL Elite Pro Coagulation Analyser. Determined for capillary blood from sample duplicates collected at multiple sites. The following results represent the mean paired rep %CV for both direct and transfer tube application. Direct Application Transfer Tube

INR Test Strip Specifications Displayed results Storage temperature Operating temperature Measuring range Sample size Sample type Fresh capillary whole blood – taken by finger-stick or via non-anticoagulated transfer tube See INR Test Product Insert for details *Supratherapeutic INR > 4.0 test result could take 90-180 seconds For more information visit www.lumiradx.com or contact the LumiraDx Customer Services by email: customerservices@lumiradx.com or at lumiradx.com. Copyright © 2020 LumiraDx UK LTD. All rights reserved, worldwide. LumiraDx and Flame logo are trademarks of LumiraDx...