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Semin Thromb Hemost 2004; 30(6): 697-702
DOI: 10.1055/s-2004-861512
Copyright © 2004 by Thieme Medical Publishers, Inc., 333 Seventh Avenue, New York, NY 10001, USA.

Point of Care Monitors for Oral Anticoagulant Therapy

Edith A. Nutescu1
  • 1Clinical Associate Professor, College of Pharmacy, The University of Illinois at Chicago, Chicago, Illinois
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Publication History

Publication Date:
04 January 2005 (online)

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ABSTRACT

Over recent years, the use of portable coagulation monitors for prothrombin time-International Normalized Ratio (PT-INR) testing has been gaining popularity. Their advantages over traditional methods of monitoring include ease of use, short test duration, faster turnaround time for dosage changes, increased patient convenience by eliminating the need to go to the laboratory for venipuncture, and increased patient-provider interaction. Portable coagulation monitors for PT-INR testing are currently used in various settings, such as anticoagulation clinics, physician offices, at the patient's bedside in hospital wards, and independently by patients at home. Numerous studies have addressed the suitability of these monitors as alternatives to traditional laboratory testing. Various point of care (POC) coagulation monitors have been developed, and many models are commercially available in the United States. Because technology differs among the various devices, accuracy and precision need to be determined for individual devices. The various devices cannot be used interchangeably, and individual device performance cannot be generalized.

KEYWORDS

Oral anticoagulants - warfarin - point of care devices - monitoring - International Normalized Ratio

REFERENCES

  • 1 Ansell J, Hirsh J, Dalen J et al.. Managing oral anticoagulant therapy.  Chest. 2001;  119 22S-38S
    CrossrefPubMedGoogle Scholar
  • 2 Quick A J. The prothrombin in hemophilia and in obstructive jaundice.  J Biol Chem. 1935;  109 73-74
    PubMedGoogle Scholar
  • 3 Hirsh J. Oral anticoagulant drugs.  N Engl J Med. 1991;  324 1865-1875
    CrossrefPubMedGoogle Scholar
  • 4 WHO Expert Committee on Biological Standardization .twenty-eighth report. World Health Organ Tech Rep Ser 1977 610 14-16 45-51
    Google Scholar
  • 5 Hirsh J, Poller L. The international normalized ratio.  Arch Intern Med. 1994;  154 282-288
    CrossrefPubMedGoogle Scholar
  • 6 Koerner S D, Fuller R E. Comparison of a portable capillary whole blood coagulation monitor and standard laboratory methods for determining International Normalized Ratio.  Mil Med. 1998;  163 820-825
    PubMedGoogle Scholar
  • 7 Tripodi A, Chantarangkul V, Mannucci P M. Near-patient testing devices to monitor oral anticoagulant therapy.  Br J Haematol. 2001;  113 847-852
    CrossrefPubMedGoogle Scholar
  • 8 van den Besselaar A M. Accuracy, precision, and quality control for point-of-care testing of oral anticoagulation.  J Thromb Thrombolysis. 2001;  12 35-40
    CrossrefPubMedGoogle Scholar
  • 9 Anderson D R, Harrison L, Hirsch J. Evaluation of a portable prothrombin time monitor for home use by patients who require long-term oral anticoagulation therapy.  Arch Intern Med. 1993;  153 1441-1447
    CrossrefPubMedGoogle Scholar
  • 10 Foulis P R, Wallach P M, Adelman H M et al.. Performance of the Coumatrak system in a large anticoagulation clinic.  Am J Clin Pathol. 1995;  103 98-102
    PubMedGoogle Scholar
  • 11 Lucas F V, Duncan A, Jay R et al.. A novel whole blood capillary technique for measuring the prothrombin time.  Am J Clin Pathol. 1987;  8 442-446
    PubMedGoogle Scholar
  • 12 Yano Y, Kambayashi J, Murata K et al.. Bedside monitoring of warfarin therapy by a whole blood capillary coagulation monitor.  Thromb Res. 1992;  66 583-590
    CrossrefPubMedGoogle Scholar
  • 13 Weibert R T, Adler D S. Evaluation of a capillary whole blood prothrombin time measurement system.  Clin Pharm. 1989;  8 864-867
    PubMedGoogle Scholar
  • 14 McCurdy S A, White R H. Accuracy and precision of a portable anticoagulation monitor in a clinical setting.  Arch Intern Med. 1992;  152 589-592
    CrossrefPubMedGoogle Scholar
  • 15 Tripodi A, Arbini A A, Chantarangkul V et al.. Are capillary whole blood coagulation monitors suitable for the control of oral anticoagulant treatment by the International Normalized Ratio?.  Thromb Haemost. 1993;  70 921-924
    PubMedGoogle Scholar
  • 16 Roche Diagnostics Corp .Package insert: CoaguChek™ S. Indianapolis. IN: Roche Diagnostics 2002
    Google Scholar
  • 17 Bayer Diagnostics. Package insert: Rapidpoint Coag™ .Tarrytown, NY; Bayer Diagnostics/Pharmanetics Inc 2002
  • 18 Rose V L, Dermott S C, Murray B F et al.. Decentralized testing for prothrombin time and activated partial thromboplastin time using a dry chemistry portable analyzer.  Arch Pathol Lab Med. 1993;  117 611-617
    PubMedGoogle Scholar
  • 19 Oberhardt B J, Dermott S C, Taylor M et al.. Dry reagent technology for rapid, convenient measurements of blood coagulation and fibrinolysis.  Clin Chem. 1991;  37 520-526
    CrossrefPubMedGoogle Scholar
  • 20 Kapiotis S, Quehenberger P, Speiser W. Evaluation of the new method Coaguchek for the determination of prothrombin time from capillary blood: comparison with Thrombotest on KC-1.  Thromb Res. 1995;  77 563-567
    CrossrefPubMedGoogle Scholar
  • 21 van den Besselaar A M. A comparison of INRs determined with a whole blood prothrombin time device and two international reference preparations for thromboplastin.  Thromb Haemost. 2000;  84 410-412
    PubMedGoogle Scholar
  • 22 van den Besselaar A M, Meeuwisse-Braun J, Schaefer-van Mansfeld H, van Rijn C, Witteveen E. A comparison between capillary and venous blood international normalized ratio determinations in a portable prothrombin time device.  Blood Coagul Fibrinolysis. 2000;  11 559-562
    CrossrefPubMedGoogle Scholar
  • 23 Kaatz S S, White R H, Hill J et al.. Accuracy of laboratory and portable monitor international normalized ratio determinations.  Arch Intern Med. 1995;  155 1861-1867
    CrossrefPubMedGoogle Scholar
  • 24 Biotrack, Inc .Package insert: ProTime® Microcoagulation System. Mountain View, CA; International Technidyne Corp 2002
    Google Scholar
  • 25 Oral Anticoagulation Monitoring Study Group . Point-of-care prothrombin time measurement for professional and patient self-testing use. A multicenter clinical experience. Oral Anticoagulation Monitoring Study Group.  Am J Clin Pathol. 2001;  115 288-296
    CrossrefPubMedGoogle Scholar
  • 26 Pierce M T, Crain L, Smith J, Mehta V. Point-of-care versus laboratory measurement of the International Normalized Ratio.  Am J Health Syst Pharm. 2000;  57 2271-2274
    PubMedGoogle Scholar
  • 27 Chapman D C, Stephens M A, Hamann G L et al.. Accuracy, clinical correlation, and patient acceptance of two handheld prothrombin time monitoring devices in the ambulatory setting.  Ann Pharmacother. 1999;  33 775-780
    PubMedGoogle Scholar
  • 28 Reed C, Rickman H. Accuracy of International Normalized Ratio determined by portable whole-blood coagulation monitor versus a central laboratory.  Am J Health Syst Pharm. 1999;  56 1619-1623
    PubMedGoogle Scholar
  • 29 Avocet, Inc .Package insert: AvoSure™ PT. San Jose, CA; Avocet Medical Inc 2000
    Google Scholar
  • 30 De Miguel D, Burgaleta C, Reyes E, Pascual T. Capillary whole blood testing by a new portable monitor. Comparison with standard determination of the international normalized ratio.  Am J Clin Pathol. 2003;  120 28-33
    CrossrefPubMedGoogle Scholar
  • 31 Rigelsky J M, Choe H M, Curtis D M et al.. Accuracy of the AvoSure PT Pro System compared with a hospital laboratory standard.  Ann Pharmacother. 2002;  36 380-385
    CrossrefPubMedGoogle Scholar
  • 32 LifeScan, Inc. Package insert: Harmony™ INR Monitoring System .Milpitas, CA; LifeScan Inc./Johnson & Johnson 2003
  • 33 Earp B, Chow H, Sharma A. LifeScan INR monitor: system description and calibration traceability.  J Thromb Thrombolysis. 2001;  12 110
    PubMedGoogle Scholar
  • 34 Earp B, Hambleton J, Spencer F, Jacobson A. Accuracy and precision of the LifeScan INR monitor in anticoagulation clinics.  J Thromb Thrombolysis. 2001;  12 109
    PubMedGoogle Scholar
  • 35 HemoSense, Inc .Product information: INRatio™ . Milpitas, CA; Hemosense, Inc 2003
    Google Scholar
  • 36 Jacobson A, Peterson M, Gunnemann T et al.. Magnitude of INR variation attributable to differences between point-of-care testing devices.  Thromb Haemost. 2001;  86(Suppl) 802a
    PubMedGoogle Scholar
  • 37 Gosselin R C, Owings J T, White R H et al.. A comparison of point-of-care instruments designed for monitoring oral anticoagulation with standard laboratory methods.  Thromb Haemost. 2000;  83 698-703
    PubMedGoogle Scholar
  • 38 Ansell J E. Empowering patients to monitor and manage oral anticoagulation therapy.  JAMA. 1999;  281 182-183
    CrossrefPubMedGoogle Scholar
  • 39 White R H, McCurdy S A, von Marensdorff H et al.. Home prothrombin time monitoring after initiation of warfarin therapy.  Ann Intern Med. 1989;  111 730-737
    PubMedGoogle Scholar
  • 40 Sawicki P T. A structured teaching and self-management program for patients receiving oral anticoagulation: a randomized controlled trial.  JAMA. 1999;  281 145-150
    CrossrefPubMedGoogle Scholar
  • 41 Ansell J, Patel N, Ostrovsky D et al.. Long-term patient self-management of oral anticoagulation.  Arch Intern Med. 1995;  155 2185-2189
    CrossrefPubMedGoogle Scholar
  • 42 Bernardo A. Experience with patient self-management of oral anticoagulation.  J Thromb Thrombolysis. 1996;  2 321-325
    CrossrefPubMedGoogle Scholar
  • 43 Cromheecke M E, Levi M, Colly L P et al.. Oral anticoagulation self-management and management by a specialist anticoagulation clinic: a randomized cross-over comparison.  Lancet. 2000;  356 97-102
    CrossrefPubMedGoogle Scholar

Edith A NutescuPharm.D. 

The University of Illinois at Chicago, College of Pharmacy

Department of Pharmacy Practice, 833 S. Wood Street; m/c 886; room 164

Chicago, IL 60612

Email: enutescu@uic.edu