Key result
LumiraDx INR Test achieves ~0.98 correlation with reference instruments across venous and capillary samples.
Why the study?
The LumiraDx INR Test is a new point-of-care diagnostic test designed to analyze fingerstick blood samples, requiring assessment in patients receiving phenprocoumon.
Does the LumiraDx INR Test accurately measure INR compared to standard reference instruments in patients receiving phenprocoumon?
Observational (n=102)
Does the LumiraDx INR Test accurately measure INR compared to standard reference instruments in patients receiving phenprocoumon?
Effect estimate: r = 0.949 to 0.981
The LumiraDx INR point-of-care test demonstrates high accuracy and strong correlation with standard laboratory reference instruments for monitoring patients on phenprocoumon.
Background The LumiraDx INR Test is a new point-of-care diagnostic test designed to analyze fingerstick blood samples. The test was assessed in patients receiving phenprocoumon (NCT04074980). Methods Venous plasma international normalized ratio (INR) was measured using the LumiraDx INR Test. LumiraDx INR Test-ascertained capillary whole blood INR was compared with venous plasma INR measured using the IL ACL Elite Pro and Sysmex CS-5100 reference instruments. Results A total of 102 patients receiving phenprocoumon were recruited. The INR results from venous plasma and capillary whole blood that were analyzed on the LumiraDx INR Test correlated well with those measured using the IL ACL Elite Pro (plasma: n = 25, r = 0.981; capillary blood: n = 74, r = 0.949) and the Sysmex CS-5100 (n = 73, r = 0.950). Conclusions The LumiraDx INR Test showed high accuracy in analyzing venous plasma and capillary whole blood from patients receiving phenprocoumon.
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Völler et al. (2020) conducted an observational in Patients receiving phenprocoumon anticoagulation therapy (n=102). LumiraDx INR Test vs. IL ACL Elite Pro and Sysmex CS-5100 reference instruments was evaluated on Correlation of INR results between LumiraDx INR Test and reference instruments (r = 0.949 to 0.981). The LumiraDx INR Test demonstrated high correlation with reference instruments for measuring INR in venous plasma (r=0.981) and capillary whole blood (r=0.949-0.950) among patients on phenprocoumon.
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