Quality assessment of CoaguChek point-of-care prothrombin time monitors: Comparison of the European Community - Approved procedure and conventional external quality assessment

Clinical Chemistry

Volumn 52, Issue 10, 2006, Pages 1843-1847

  Poller, Leon ^a   Keown, Michelle ^a   Ibrahim, Saied A ^a   Van Der Meer, Felix J M ^b   Van Den Besselaar, Anton M H P ^b   Tripodi, Armando ^c   Jespersen, Jörgen ^d   Meijer, Pieter ^e   Kluft, Cornelis ^e  

^a UNIVERSITY OF MANCHESTER   (United Kingdom)

^b LEIDEN UNIVERSITY MEDICAL CENTER   (Netherlands)

^c FONDAZIONE IRCCS CA GRANDA OSPEDALE MAGGIORE POLICLINICO   (Italy)

^d ESBJERG HOSPITAL   (Denmark)

^e Foundation of the European Concerted Action on Thrombophilia (ECAT)   (Netherlands)

Author keywords

[No Author keywords available]

Indexed keywords

ANTICOAGULANT AGENT;

COMPARATIVE STUDY; EUROPE; INTERNATIONAL NORMALIZED RATIO; MONITOR; PERFORMANCE; PRACTICE GUIDELINE; PROTHROMBIN TIME; QUALITY CONTROL; RELIABILITY; REVIEW; VALIDATION PROCESS;

ADMINISTRATION, ORAL; ANTICOAGULANTS; DRUG MONITORING; EUROPEAN UNION; HUMANS; INTERNATIONAL NORMALIZED RATIO; POINT-OF-CARE SYSTEMS; PROTHROMBIN TIME; QUALITY CONTROL; REPRODUCIBILITY OF RESULTS;

EID: 33749132364     PISSN: 00099147     EISSN: None     Source Type: Journal    
DOI: 10.1373/clinchem.2006.071639     Document Type: Review

References (12)

1. Cannegieter SC, Rosendaal FR, Wintzen AR, van der Meer FJ, Vandenbroucke JP, Briet E. Optimal oral anticoagulant therapy in patients with mechanical heart valves. N Engl J Med 1995;333:11-7.
2. Murray ET, Fitzmaurice DA, Kitchen D, Jennings I, McCahon D, Kitchen S, et al. An evaluation of four methods of external quality assurance (EQA) for patient self-management of oral anticoagulation [Abstract]. Br J Haematol 2005;129(Suppl 1):37.
3. Tripodi A, Bressi C, Carpenedo M, Chantarangkul V, Clerici M, Mannucci PM. Quality assurance program for whole blood prothrombin time-international normalized ratio point of care monitors used for patient self-testing to control anticoagulation. Thrombosis Res 2004;113:35-40.
4. WHO Expert Committee on Biological Standardisation. 33rd Report. WHO Technical Report Series 1983;687:81-105.
5. Poller L, Keown M, Chauhan N, van den Besselaar AMHP, Tripodi A, Shiach C, et al. Normalisation and Standardisation of Home PT Monitors (SMT4-CT98-2269). Technology Implementation Plan 2002 Brussels, Belgium: European Commission.
6. Poller L, Keown M, Chauhan N, van den Besselaar AMHP, Meeuwisse-Braun J, Tripodi A, et al. European Concerted Action on Anticoagulation (ECAA). Use of plasma samples to derive International Sensitivity Index of whole blood prothrombin time monitors. Clin Chem 2000;48:255-60.
7. Poller L, Keown M, Chauhan N, van den Besselaar AMHP, Tripodi A, Shiach C, et al. European Concerted Action on Anticoagulation. Quality assessment of the CoaguChek Mini and TAS PT-NC point of care whole blood prothrombin time monitors. Clin Chem 2004;50:537-44.
8. Tripodi A, Arbini AA, Chantarangkul V, Bettega D, Mannucci PM. Are capillary whole blood coagulation monitors suitable for the control of oral anticoagulant treatment by the International Normalized Ratio? Thromb Haemost 1993;70:921-4.
9. Poller L, Keown M, van den Besselaar AMHP, Meeuwisse-Braun J, Tripodi A, Clerici M. The use of ECAA calibrant plasmas for quality control of home PT monitors-inter-lot variability of test strips/cartridges [Abstract]. Thromb Haemost 2001;86(Suppl):1418.
10. Poller L, Keown M, Chauhan N, van den Besselaar AMHP, Tripodi A, Shiach C, et al. An assessment of a method for ISI calibration of two whole blood point-of-care PT monitor systems based on lyophilised plasmas using whole blood equivalent PT. J Thromb Haemost 2003;1:766-72.
11. Poller L, Keown M, Chauhan N, van den Besselaar AMHP, Tripodi A, Shiach C, et al. An assessment of lyophilised plasmas for ISI calibration of CoaguChek and TAS whole blood prothrombin time monitors. J Clin Pathol 2003;56:114-9.
12. Poller L, Keown M, Chauhan N, van den Besselaar AMHP, Tripodi A, Shiach C, et al. Reliability of international normalised ratios from two point of care test systems: comparison with conventional method. Br Med J 2003;327:30-4.