Precision and accuracy of point-of-care testing coagulometers used for self-testing and self-management of oral anticoagulation therapy.

BACKGROUND: Oral anticoagulation therapy is monitored by the use of the International Normalized Ratio (INR). Patients who perform self-testing or self-management use a point-of-care testing (POCT) coagulometer (INR monitor) to estimate their INRs. A precondition for a correct dosage of coumarins is a correct INR estimation, and the method and apparatus used for providing the INR measurements are crucial in this context. Several studies have been published regarding the precision and accuracy of these POCT coagulometers, and have led to diverse conclusions. It is difficult and challenging to perform an overview of the literature, owing to the vast amount of papers, with differences in design, statistical analysis, etc.
OBJECTIVES: The aim of this systematic review was to analyze the current literature, especially regarding the precision and accuracy of the POCT coagulometers, to provide recommendations for clinical use and quality control, and to point out areas for future research.
METHODS: We included a total of 22 studies, of which four were characterized as high-quality studies.
RESULTS: The precision of the POCT coagulometers was generally adequate for clinical use. Their performance in terms of accuracy has to be viewed in the context of the inherent inaccuracies of INR measurements.
CONCLUSIONS: The accuracy of POCT coagulometers seems, in this respect, to be generally acceptable, and they can be used in a clinical setting.