LumiraDx INR 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.
LumiraDx 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.
| Displayed results | INR |
| Storage temperature | Between 5 ºC and 32 ºC (41 ºF and 89 ºF) |
| Operating temperature | Between 15 ºC and 30 ºC (59 ºF and 86 ºF) |
| Measuring range | 0.8–7.5 INR |
| Sample size | Capillary: 8 µL |
| Sample type | Fresh capillary whole blood – taken by finger-stick or via non-anticoagulated transfer tube |
| Time to result | INR results in 60–90 seconds* |
| ISI | Approx. 1.0 |
| Interferences | See INR Test Product Insert for details |