Abstract Number: PB0434
Meeting: ISTH 2020 Congress
Theme: Diagnostics and OMICs » Biomarkers of Thrombosis and Hemostasis
Background: The LumiraDx Platform is a novel, point of care in vitro diagnostic system that can be used for INR Testing by Healthcare Professionals. It has been shown that comparing results from the LumiraDx INR Test to those obtained with common laboratory reagents shows that the LumiraDx INR Test correlates well with IL ACL Elite Pro (ACL) with HemosIL RecombiPlasTin 2G.
Aims: A sample comparison was carried out to demonstrate the performance of IL ACL Elite Pro (ACL) and Sysmex CS instruments (CS-2500 and CS-5100) with plasma as reference methods for the LumiraDx INR Test using a capillary blood sample.
Methods: 101 blood samples were collected from patients attending anticoagulation clinics and their INR values were established using the LumiraDx INR Test (capillary) and ACL Elite Pro (plasma). Frozen plasma samples from routine calibration testing were sent to four independent laboratories for INR testing using the Sysmex CS Instruments, with Siemens Dade® Innovin® Thromboplastin. Passing-Bablok regression was used in a method comparison of data obtained.
Results: Analysis confirmed a good agreement between the LumiraDx INR Test results (capillary blood sample) from plasma samples using both the ACL Elite Pro and also the Sysmex CS 2500/5100.
| Laboratory | Slope | 95% CI Upper | 95% CI Lower | Intercept | 95% CI Upper | 95% CI Lower | n |
| Average over 4 sites | 0.9470 | 0.9927 | 0.9019 | 0.1025 | 0.2070 | -0.007072 | 101 |
[Table 1: ACL Elite Pro vs Sysmex (average results from 4 sites)]
Furthermore, data from the Sysmex CS 2500/5100 was demonstrated to correlate across 4 independent hospital laboratories.
| Slope | 95% CI Upper | 95% CI Lower | Intercept | 95% CI Upper | 95% CI Lower | n | |
| Average over 4 sites | 1.001 | 1.060 | 0.9481 | -0.06174 | 0.04839 | -0.1860 | 223 |
[Table 2: LumiraDx vs Sysmex (average results from 4 sites)]
Conclusions: The LumiraDx INR Test, ACL Elite Pro and the Sysmex CS2500 and 5100 laboratory reference methods returned comparable results, and agree closely when compared across 4 independent sites.
Funding: This study was sponsored by LumiraDx UK Ltd. 09206123
To cite this abstract in AMA style:
Taggart K, Roodt A, Paget A, Ellis J. Laboratory Accuracy Assessment of a Novel INR Point-of-Care Test Compared with Laboratory Reference Methods Used Across Four Independent Clinical Sites [abstract]. Res Pract Thromb Haemost. 2020; 4 (Suppl 1). https://abstracts.isth.org/abstract/laboratory-accuracy-assessment-of-a-novel-inr-point-of-care-test-compared-with-laboratory-reference-methods-used-across-four-independent-clinical-sites/. Accessed October 1, 2023.« Back to ISTH 2020 Congress
ISTH Congress Abstracts - https://abstracts.isth.org/abstract/laboratory-accuracy-assessment-of-a-novel-inr-point-of-care-test-compared-with-laboratory-reference-methods-used-across-four-independent-clinical-sites/