The purpose of this study is to assess the measurement conformity of an in vitro diagnostic device measuring the INR (International harmonized Ratio).
The investigators will assess the performance of an in vitro diagnostic device for assessing the INR. The evaluation will consist of make several INR measurements using the device and compare these measures to the reference value. The INR will be measured using the study device on capillary blood drops taken from the fingertip. In the same way a venous blood sampling will be carried out to measure a reference INR. A total of 20 healthy subjects and 180 patients treated with vitamin K agonist will be enrolled in the study.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
220
the procedure involves a series of repeated measurements of INR with the studied device
Clinical research center of Grenoble university hospital
Grenoble, Auvergne-Rhône-Alpes, France
Accuracy of measurement of the INR with the study device
The INR value of each measure with the study device will be compared to the reference INR measured by a central laboratory on a concomitant venous blood sample.
Time frame: Just after the blood taken at day 1
Repeatability of measurement of the INR with the study device
Comparison of 8 INR measurements performed with the device in a range of 15 minutes.
Time frame: Just after the blood taken at day 1
Reproductibility of measurement of the INR with the study device
Comparison of 8 INR measurements performed with the device in a range of 15 minutes. The modified parameters between measurements will be the lot of consumables and the study device
Time frame: Just after the blood taken at day 1
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