Abstract
BACKGROUND: A number of instruments have been developed for determination of prothrombin time (PT) and International Normalised Ratio (INR) at locations not limited to central laboratories. AIM: To evaluate one such portable instrument, the Thrombolytic Assessment System (TAS), which can be used in a near-patient setting. METHODS: Samples from 20 normal subjects and 48 patients treated with warfarin for venous thromboembolic disease were studied. The warfarin group was divided into: initiation phase (n = 10), combined warfarin and heparin (n = 10), stabilised therapy (n = 20), and over anticoagulated patients (n = 8). PTs and INRs were determined in each group using three conventional thromboplastins (Diagen Activated, Manchester Reagent, and Instrumentation Laboratory) and two TAS techniques (whole blood or plasma). An independent International Sensitivity Index (ISI) calibration of the TAS system was performed. RESULTS: Calculated ISIs for the TAS were 1.028 and 0.984 for plasma and whole blood analysis, respectively, compared with manufacturer's values of 0.98 and 0.97. INR results with TAS (whole blood) were 11% less than those obtained with Diagen Activated (p < 0.01) and 16% less than those obtained with Instrumentation Laboratory (p < 0.001) when manufacturers' mean normal PT and ISI were used for TAS INRs. TAS (whole blood) results were similar to TAS plasma or Manchester Reagent results. The use of a locally determined mean normal prothrombin time (MNPT) improved agreement between TAS and the other reagents, abolishing the significant difference between INRs determined with TAS (whole blood) and Diagen Activated techniques. CONCLUSION: The TAS system can be used with whole blood or plasma and produces similar INRs to those obtained with Diagen Activated or Manchester Reagent using manufacturer's ISI and a locally determined MNPT. Results were lower with TAS or Manchester Reagent compared with those obtained with Instrumentation Laboratory thromboplastin.
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Selected References
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- Ansell J. E. Imprecision of prothrombin time monitoring of oral anticoagulation. A survey of hospital laboratories. Am J Clin Pathol. 1992 Aug;98(2):237–239. doi: 10.1093/ajcp/98.2.237. [DOI] [PubMed] [Google Scholar]
- Bland J. M., Altman D. G. Statistical methods for assessing agreement between two methods of clinical measurement. Lancet. 1986 Feb 8;1(8476):307–310. [PubMed] [Google Scholar]
- Bussey H. I., Force R. W., Bianco T. M., Leonard A. D. Reliance on prothrombin time ratios causes significant errors in anticoagulation therapy. Arch Intern Med. 1992 Feb;152(2):278–282. [PubMed] [Google Scholar]
- Denson K. W. Thromboplastin--sensitivity, precision and other characteristics. Clin Lab Haematol. 1988;10(3):315–328. doi: 10.1111/j.1365-2257.1988.tb00025.x. [DOI] [PubMed] [Google Scholar]
- Foulis P. R., Wallach P. M., Adelman H. M., Sanford B. H., McCain J., Reed D., Schlede C. M., Kokseng C. U., Taylor C. D. Performance of the Coumatrak system in a large anticoagulation clinic. Am J Clin Pathol. 1995 Jan;103(1):98–102. doi: 10.1093/ajcp/103.1.98. [DOI] [PubMed] [Google Scholar]
- Hirsh J., Levine M. Confusion over the therapeutic range for monitoring oral anticoagulant therapy in North America. Thromb Haemost. 1988 Apr 8;59(2):129–132. [PubMed] [Google Scholar]
- Kitchen S., Jennings I., Woods T. A., Walker I. D., Preston F. E. Two recombinant tissue factor reagents compared to conventional thromboplastins for determination of international normalised ratio: a thirty-three-laboratory collaborative study. The Steering Committee of the UK National External Quality Assessment Scheme for Blood Coagulation. Thromb Haemost. 1996 Sep;76(3):372–376. [PubMed] [Google Scholar]
- Kitchen S., Walker I. D., Woods T. A., Preston F. E. Thromboplastin related differences in the determination of international normalised ratio: a cause for concern? Steering Committee of the UK National External Quality Assessment Scheme in Blood Coagulation. Thromb Haemost. 1994 Sep;72(3):426–429. [PubMed] [Google Scholar]
- Loeliger E. A., van den Besselaar A. M., Lewis S. M. Reliability and clinical impact of the normalization of the prothrombin times in oral anticoagulant control. Thromb Haemost. 1985 Feb 18;53(1):148–154. [PubMed] [Google Scholar]
- Oberhardt B. J., Dermott S. C., Taylor M., Alkadi Z. Y., Abruzzini A. F., Gresalfi N. J. Dry reagent technology for rapid, convenient measurements of blood coagulation and fibrinolysis. Clin Chem. 1991 Apr;37(4):520–526. [PubMed] [Google Scholar]
- Rose V. L., Dermott S. C., Murray B. F., McIver M. M., High K. A., Oberhardt B. J. Decentralized testing for prothrombin time and activated partial thromboplastin time using a dry chemistry portable analyzer. Arch Pathol Lab Med. 1993 Jun;117(6):611–617. [PubMed] [Google Scholar]
- Thomson J. M., Darby K. V., Poller L. Calibration of BCT/441, the ICSH reference preparation for thromboplastin. Thromb Haemost. 1986 Jun 30;55(3):379–382. [PubMed] [Google Scholar]
- Tripodi A., Arbini A. A., Chantarangkul V., Bettega D., Mannucci P. M. Are capillary whole blood coagulation monitors suitable for the control of oral anticoagulant treatment by the international normalized ratio? Thromb Haemost. 1993 Dec 20;70(6):921–924. [PubMed] [Google Scholar]
- White R. H., Becker D. M., Gunther-Maher M. G. Outpatient use of a portable international normalized ratio/prothrombin time monitor. South Med J. 1994 Feb;87(2):206–210. doi: 10.1097/00007611-199402000-00012. [DOI] [PubMed] [Google Scholar]
