Point-of-care monitoring of vitamin K-antagonists: Validation of CoaguChek XS test strips with International Standard thromboplastin
Department of Thrombosis and Hemostasis, Leiden University Medical Centre, Leiden, The Netherlands. Journal of clinical pathology
(Impact Factor: 2.92).
08/2012; 65(11):1031-5. DOI: 10.1136/jclinpath-2012-200934
Many patients treated with vitamin K-antagonists (VKA) use point-of-care (POC) whole blood coagulometers for self-testing. The majority of patients in the Netherlands use one type of POC coagulometer, that is, the CoaguChek XS. Each new lot of test strips for the CoaguChek XS is validated by a group of collaborating thrombosis centres. We assessed the International Normalised Ratio (INR) differences between each of 51 new lots of test strips and the International Standard for thromboplastin rTF/95 or its successor rTF/09.
Each year, a particular lot of CoaguChek XS test strips was used as reference lot. The reference lot was validated by comparison to the International Standard, yielding a relationship between the reference lot INR and International Standard INR. Successive lots of test strips were compared to the reference lot by three centres using 19-29 capillary blood samples obtained from VKA-treated patients. Each patient provided two blood drops from the same finger prick, one for the reference lot strip and one for the new lot.
The mean INR differences between each lot and the International Standard varied between -8% and +4%. The mean absolute values of the relative differences varied between 2.4% and 8.1%. There were small but clinically unimportant differences in INR between the first and second drop of blood.
Accuracy of CoaguChek XS INR determinations can be assessed by a group of collaborating centres using a limited number of capillary blood samples. As the mean INR differences with the International Standard were smaller than 10%, the lots were approved for use by the Netherlands Thrombosis Services.
Available from: Dr. Job Harenberg
- "The underuse of vitamin-K antagonists is one of the consequences of the fear of bleeding complications especially in older . One option to improve the efficacy and safety of treatment with VKA is to adopt point-of-care whole blood devices for self-testing and self-management [6-8]. However, this option is limited to a small group of patients able to follow the instruction of the POC device and restricted by the unwillingness of health insurance systems to cover the additional expenses . "
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ABSTRACT: New oral anticoagulants (NOAC) are approved for several indications for prophylaxis and treatment of venous thromboembolism and for prevention of embolism in atrial fibrillation at fixed daily doses without need of laboratory guided dose adjustment. Due to their low molecular weight of about 500 to 600 Dalton and their hydrophilicity free anticoagulant is excreted immediately through glomerular filtration into the urine. Impairment of renal function may increase the plasma concentration of the anticoagulants and lowered creatinine clearance is a declared contraindication. In contrast to the initial aim of development the anticoagulant effect is required to be determined in special clinical situations. Several specific and non-specific assays using plasma samples are currently undergoing standardization. As all NOACs are excreted into the urine, specific assays were developed for this matrix to determine them quantitatively of qualitatively. Urine samples can be easily and repetitively obtained avoiding problems and risks associated with blood sampling. The qualitative assay can be performed as a point of care test (POC) also by the patient by judging the different colours for the absence or presence of the drugs with the naked eye. The test is rapid (results available within 15 min), sensitive, specific and accurate and does not require a purified NOAC as control. The tests may be a tool for clinicians who need to know for treatment decisions if a NOAC is on board or not. As the tests are specific for oral direct thrombin inhibitors and for oral direct factor Xa inhibitors, the indication does not interfere with other qualitative POC test in development using clotting systems. The test may be indicated for patients at acute hospitalization, before surgery or central nervous system puncture anaesthesia, if fibrinolytic therapy is indicated, acute deterioration of renal function, and for control of adherence to therapy.
Thrombosis Journal 08/2013; 11(1):15. DOI:10.1186/1477-9560-11-15 · 1.31 Impact Factor
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ABSTRACT: Thrombolysis with alteplase (rt-PA) is accepted hyperacute therapy for acute ischaemic stroke. Clotting must be normal before this can be administered safely. Laboratory testing of INR takes 30 - 60 minutes which can significantly delay administration of rt-PA. Previous studies have suggested point-of-care testing is useful in patients presenting with stroke and improve door to needle time. We performed a prospective study of point-of-care testing in patients presenting with acute stroke.
50 patients were entered into the study to compare point-of-care testing using the CoaguChek(®) XS system with laboratory testing of INR.
Point of care testing correlated well with laboratory levels (R=0.93, P < 0.0001). Only 2 patients had a high INR reading (>1.6). The standard deviation of difference between the two was 0.115. Overall point-of -care testing tended to underestimate INR slightly, meaning that an INR value of 1.1 or less was required to be 95% certain that the laboratory value was 1.3 or below. Simultaneous testing using blood from a syringe was more consistent with laboratory results than testing capillary blood via finger-prick.
Point of care INR testing correlates well with laboratory values. The results in this study mostly relate to levels in the normal range. We suggest that it can be appropriately used to shorten door-to-needle time.
Internal Medicine Journal 07/2013; 43(11). DOI:10.1111/imj.12255 · 1.64 Impact Factor
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ABSTRACT: Monitoring of the anticoagulant effect with the International normalized ratio (INR) is essential for patients receiving vitamin K antagonists (VKAs). The majority of point of care (POC) devices for INR monitoring has shown a good precision and accuracy with results similar to those obtained in a laboratory. In many countries, INR POC devices are widely used at home by the patients for self-testing. Their use in the hospital by the clinical staff (doctor or nurses) for bedside measurement is also growing. The INR POC testing is performed using fully automated devices. Capillary blood samples are easy to obtain. In the emergency room, POC INR devices are commonly used. This improves the quality of care for patient with suspicion of VKAs overdosage. INR measurement using bedside monitors is also of great interest in care units for specific populations of patients like paediatrics or geriatrics. Moreover, bedside INR monitoring may be useful in anticoagulant clinics or when the care unit is far from a laboratory. Although the bedside INR monitors are easy to use, their implementation requires adequate training and intermittent re-evaluation of any person performing the tests to ensure reliability of results. Such equipment must comply with EN ISO 22870 standard for POC testing accreditation, under the supervision of a biologist. In order to achieve these targets, connect the instrument to the laboratory's data management system is essential.
11/2013; 71(S1):59-69. DOI:10.1684/abc.2013.0904
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