- #ISTAT CALIBRATION VERIFICATION PROCEDURE MANUAL#
- #ISTAT CALIBRATION VERIFICATION PROCEDURE PORTABLE#
PSM in OAT means that the patient analyzes a drop of blood with a portable POCT coagulometer (INR monitor). There are different methods of managing OAT, including routine care (provided by the general practitioner), hospital outpatient clinics, highly specialized anticoagulation clinics, shared care, use of computer-assessed dosage, patient self-testing (PST), and patient self-management (PSM). Optimized management of OAT improves the clinical quality of treatment, and high-quality OAT is still an alternative to novel oral anticoagulants, e.g.
#ISTAT CALIBRATION VERIFICATION PROCEDURE MANUAL#
Today, however, the manual PT technique has been almost universally replaced by automated point-of-care testing (POCT) coagulometers. The INR system of PT standardization was originally based on manual tilt tube determination of PTs, and envisaged the assignment of a single International Sensitivity Index (ISI) value for each batch of thromboplastin reagent. Differences in INRs obtained with the same test sample are observed, but this fact should not be regarded as an indictment of the INR system, but as merely reflecting the variables in PT testing.
The INR is a mathematically adjusted prothrombin time (PT), for which reason the ‘objective true’ INR is not known.
Monitoring is based on the International Normalized Ratio (INR), which is conventionally determined on citrated plasma obtained by venepuncture. Oral anticoagulation therapy (OAT) with coumarins (vitamin K antagonists) has been available for more than 60 years, and is prescribed for both prophylactic and therapeutic use in patients at increased risk of thromboembolism. Conclusions: The accuracy of POCT coagulometers seems, in this respect, to be generally acceptable, and they can be used in a clinical setting. Their performance in terms of accuracy has to be viewed in the context of the inherent inaccuracies of INR measurements. Results: The precision of the POCT coagulometers was generally adequate for clinical use. Methods: We included a total of 22 studies, of which four were characterized as high-quality studies. 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. 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. Several studies have been published regarding the precision and accuracy of these POCT coagulometers, and have led to diverse conclusions. 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. Patients who perform self-testing or self-management use a point-of-care testing (POCT) coagulometer (INR monitor) to estimate their INRs. Background: Oral anticoagulation therapy is monitored by the use of the International Normalized Ratio (INR).