Related Experiment Videos
Multicenter evaluation of a new capillary blood prothrombin time monitoring system
A M van den Besselaar1, K Breddin, G Lutze
1Department of Hematology, University Hospital, Leiden, Netherlands.
Insights
The CoaguChek system demonstrates reliable analytical performance for capillary blood prothrombin time (PT) monitoring. This convenient system is suitable for decentralized PT testing in patients on oral anticoagulation therapy.
Area of Science:
- Clinical Chemistry
- Hematology
- Medical Devices
Background:
- Oral anticoagulation therapy requires regular monitoring of prothrombin time (PT).
- Decentralized testing offers convenience but requires accurate and reliable monitoring systems.
Purpose of the Study:
- To evaluate the analytical performance of the CoaguChek capillary blood prothrombin time monitoring system.
- To assess the system's suitability for decentralized PT testing.
Main Methods:
- Multicenter evaluation across six hospitals.
- Imprecision studies using control plasma and patient blood.
- Comparison of CoaguChek PT results with Hepato Quick and Thromborel S assays using citrated venous plasma from 359 patients on oral anticoagulation.
Main Results:
- CoaguChek showed coefficients of variation of approximately 7% in plasma and 4% in blood.
- Acceptable agreement with Hepato Quick (r=0.888) and good agreement with Thromborel S (r=0.895).
- Concordance with comparison methods exceeded 80% (Hepato Quick: 81%, Thromborel S: 83%).
Conclusions:
- The CoaguChek system exhibits good analytical performance.
- Convenient handling makes it suitable for decentralized prothrombin time testing.
Abstract:
The analytical performance of the new capillary blood prothrombin time monitoring system CoaguChek was examined in a multicenter evaluation at six hospitals. The coefficients of variation of the INR obtained in the CoaguChek imprecision study were approximately 7% in the control plasma provided (within-run and day-to-day) and 4% in blood (within-run). The prothrombin times were ascertained in capillary blood (CoaguChek PT Test) and citrated venous plasma (Hepato Quick, Thromborel S) from 359 patients under oral anticoagulation therapy with phenprocoumon, acenocoumarin or warfarin. The agreement with the test results obtained with the comparison methods was acceptable versus Hepato Quick assay (n = 359; y = 1.23 x -0.49, r = 0.888) and good versus Thromborel S method (n = 359; y = 1.09 x -0.28, r = 0.895). A simplified assessment of all test results (n = 795) in a nine-field comparison table showed a concordance with the comparison methods of more than 80 (Hepato Quick: 81%, Thromborel S: 83%). The concordance between Hepato-Quick and Thromborel S was slightly higher (88%). Its good analytical performance and convenient handling recommend the CoaguChek system as a suitable system for decentralized prothrombin time testing.