Analytical accuracy and precision of two novel Point-of-Care systems for INR determination

Thrombosis Research

Volumn 135, Issue 3, 2015, Pages 526-531

  Van Den Besselaar, A M H P ^a   Van Der Meer, F J M ^a   Abdoel, C F ^a   Witteveen, E ^a  

^a LEIDEN UNIVERSITY MEDICAL CENTER   (Netherlands)

Author keywords

[No Author keywords available]

Indexed keywords

ANTIVITAMIN K; THROMBOPLASTIN;

ANALYZER; ARTICLE; BLOOD; BLOOD CLOTTING TIME; DIAGNOSTIC ACCURACY; HOSPITAL INFORMATION SYSTEM; HUMAN; INTERNATIONAL NORMALIZED RATIO; MAJOR CLINICAL STUDY; PLASMA; PRIORITY JOURNAL; PROTHROMBIN TIME; VENOUS BLOOD; CALIBRATION; COMPARATIVE STUDY; FEMALE; MALE; PROCEDURES;

CALIBRATION; FEMALE; HUMANS; INTERNATIONAL NORMALIZED RATIO; MALE; POINT-OF-CARE SYSTEMS; PROTHROMBIN TIME;

EID: 84925756923     PISSN: 00493848     EISSN: 18792472     Source Type: Journal    
DOI: 10.1016/j.thromres.2014.12.022     Document Type: Article

References (19)

1. T.B.L. Kirkwood Calibration of reference thromboplastins and standardisation of the prothrombin time ratio Thromb Haemost 49 1983 238 244
2. I. Leichsenring, W. Plesch, V. Unkrig, S. Kitchen, D.P. Kitchen, and R. Maclean Multicentre ISI assignment and calibration of the INR measuring range of a new point-of-care system designed for home monitoring of oral anticoagulant therapy Thromb Haemost 97 2007 856 861
3. W. Plesch, and A.M.H.P. van den Besselaar Validation of the international normalized ratio (INR) in a new point-of-care system designed for home monitoring of oral anticoagulation therapy Int J Lab Hematol 31 2009 20 25
4. W. Plesch, T. Wolf, N. Breitenbeck, L.D. Dikkeschei, A. Cervero, and P.L. Perez Results of the performance verification of the CoaguChek XS system Thromb Res 123 2008 381 389
5. U. Taborski, S.L. Braun, and H. Völler Analytical performance of the new coagulation monitoring system INRatio™ for the determination of INR compared with the coagulation monitor CoaguChek® S and an established laboratory method J Thromb Thrombolysis 18 2004 103 107
6. T.D. Christensen, and T.B. Larsen Precision and accuracy of point-of-care testing coagulometers used for self-testing and self-management of oral anticoagulation therapy J Thromb Haemost 10 2012 251 260
7. WHO Expert Committee on Biological Standardization Guidelines for thromboplastins and plasma used to monitor oral anticoagulant therapy with vitamin K antagonists WHO Technical Report Series 979 2013 271 316
8. J.M. Bland, and D.G. Altman Comparing methods of measurement: why plotting difference against standard method is misleading Lancet 346 1995 1084 1087
9. S.C. Kaatz, R.H. White, J. Hill, E. Mascha, J.E. Humphries, and D.M. Becker Accuracy of laboratory and portable monitor international normalized ratio determinations. Comparison with a criterion standard Arch Intern Med 155 1995 1861 1867
10. J. Hill Determination of INR accuracy: methods of analysis Haemostasis 26 Suppl. 3 1996 A422
11. L. Poller, M. Keown, S.A. Ibrahim, F.J.M. van der Meer, A.M.H.P. van den Besselaar, and A. Tripodi Quality assessment of CoaguChek Point-of-Care prothrombin time monitors: comparison of the European Community-approved procedure and conventional external quality assessment Clin Chem 52 2006 1843 1847
12. U. Taborski, and W. Plesch Equivalence of capillary versus venous INR results and patient- versus professional-determined INR values using the CoaguChek S system Clin Appl Thromb Hemost 8 2002 187 189
13. A.M.H.P. Van den Besselaar, N.C.V. Péquériaux, M. Ebben, J. van der Feest, K. de Jong, and M.B.J. Ganzeboom Point-of-care monitoring of vitamin K-antagonists: validation of CoaguChek XS test strips with International standard thromboplastin J Clin Pathol 65 2012 1031 1035
14. J.H.H. Van Geest-Daalderop, N.C.V. Péquériaux, and A.M.H.P. van den Besselaar Variability of INR in patients on stable long-term treatment with phenprocoumon and acenocoumarol and implications for analytical quality requirements Thromb Haemost 102 2009 588 592
15. J.H.H. Van Geest-Daalderop, R.J. Kraaijenhagen, F.J.M. van der Meer, and A.M.H.P. van den Besselaar Intraindividual variation of the International Normalized Ratio in patients monitored with a recombinant human thromboplastin J Thromb Haemost 8 2010 1641 1642
16. A.M.H.P. Van den Besselaar, P. Fogar, V. Pengo, G. Palareti, S. Braham, and M. Moia Biological variation of INR in stable patients on long-term anticoagulation with warfarin Thromb Res 130 2012 535 537
17. U.O. Sølvik, P.H. Petersen, G. Monsen, A.V. Stavelin, and S. Sandberg Discrepancies in International Normalized Ratio results between instruments: a model to split the variation into subcomponents Clin Chem 56 2010 1618 1626
18. M. Wieloch, A. Hillarp, K. Strandberg, C. Nilsson, and P.J. Svensson Comparison and evaluation of a Point-of-care device (CoaguChek XS) to Owren-type prothrombin time assay for monitoring of oral anticoagulant therapy with warfarin Thromb Res 124 2009 344 348
19. A. Stavelin, P.H. Petersen, U.∅. Sølvik, and S. Sandberg External quality assessment of point-of-care methods: model for combined assessment of method bias and single-participant performance by the use of native patient samples and noncommutable control materials Clin Chem 59 2013 363 371