INR Test
measuring prothrombin time reported as International Normalized Ratio (INR) from a single, direct fingerstick blood sample – all in less than 90 seconds*. The test is used for monitoring patients on oral anticoagulation therapy with Vitamin-K Antagonist (VKA) drugs. Used with the LumiraDx Instrument, the INR test delivers rapid results at the point of care.
*Supratherapeutic INR > 4.0 test result could take 90-180 seconds
Quantitative INR
The LumiraDx INR test measures quantitative prothrombin time, reported as International Normalised Ratio (INR).
Near-patient testing
A point of care test for use with the LumiraDx Instrument.
Purpose
Used for the monitoring of oral anticoagulation therapy with vitamin K antagonist (VKA) drugs.
Benefits
Rapid, reliable, lab-comparable INR results - at the patient's side
INR is the preferred test for monitoring patients on vitamin K antagonist (VKA) therapy. The LumiraDx INR test is performed at the point of care with lab comparable results from direct fingerstick sampling.
- Sample type: direct fingerstick (or non-anticoagulated transfer tube)
- Sample size: 8 μL
- Reportable range 0.8 - 8.0 INR*
- Time to result: 60 - 90 secs**
- Storage at room temperature (5°C to 32 °C)
*Applicable from INR test strip Lot 5000811 onwards
**Supratherapeutic INR > 4.0 test result could take 90-180 seconds
Workflow
Results in less than 90 seconds*
The workflow process is comprised of a fingerstick sample collection, followed by step-by-step guidance of the Instrument to report a patient result in less than 90 seconds from sample application.
The Instrument and test strips are integrated with several quality control checks to ensure the Instrument and test are functioning correctly for every test run.
*Supratherapeutic INR > 4.0 test result could take 90-180 seconds
HOW TO USE VIDEOTest performance
Clinical performance
In the OPTIMAL clinical trial, the LumiraDx INR test correlated strongly with the Instrumentation Laboratory ACL Elite laboratory reference method. The trial found that the LumiraDx INR test provided rapid and reliable INR results at the point of care1.
1. Tait RC, Hung A, Gardner RS. Performance of the LumiraDx Platform INR Test in an Anticoagulation Clinic Point-of-Care Setting Compared With an Established Laboratory Reference Method. Clin Appl Thromb Hemost. 2019.
Test precision
The LumiraDx INR test is highly precise with a mean %CV of 3.46 for direct application and 3.73 using a transfer tube.
Product Documentation
INR Test:
INR Test