The international normalized ratio (INR): What reagent, what instrument? The assessment of the agreement between INR values according to different reagent/instrument combinations.

What is known and objective The international normalized ratio ( INR) is widely used to monitor patients on vitamin K antagonists. This study aimed to assess the agreement of INR values obtained with different thromboplastin/instrument combinations. Material and methods International normalized rati...

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Published in:Journal of Clinical Pharmacy & Therapeutics Vol. 43; no. 1; pp. 52 - 59
Main Authors: Baccouche, H., Chakroun, A., Zoghlami, A., Mahjoub, S., Ben Romdhane, N.
Format: research tables/charts Journal Article
Published: Wiley-Blackwell Feb2018
Online Access:View this record in EBSCOhost
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        10.1111/jcpt.12608
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        atl: The international normalized ratio (INR): What reagent, what instrument? The assessment of the agreement between INR values according to different reagent/instrument combinations.
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        au:
          Baccouche, H.
          Chakroun, A.
          Zoghlami, A.
          Mahjoub, S.
          Ben Romdhane, N.
        affil: Hematology Department, Faculty of Medicine of Tunis, Rabta Hospital, Tunis University El Manar, Tunis, Tunisia
      sug:
        subj:
          International Normalized Ratio Evaluation
          Indicators and Reagents
          Blood Coagulation Classification
          Vitamin K Antagonists and Inhibitors
          Prothrombin Time
          Thromboplastin
          Human
          Sample Size
          Calibration
          kappa Statistic
      ab: What is known and objective The international normalized ratio ( INR) is widely used to monitor patients on vitamin K antagonists. This study aimed to assess the agreement of INR values obtained with different thromboplastin/instrument combinations. Material and methods International normalized ratio was determined on plasmas from 330 patients undergoing antivitamin K treatment (with acenocoumarol), using two calibration methods and four reagent/instrument combinations: Both Neoplastine CI and Neoplastine CI Plus on STA-R instrument from Diagnostica STAGO, Asnières, France; and both Thromborel S and Innovin on SYSMEX 2100i instrument from Siemens Health Care Diagnostics, Marbung, Germany. The agreement analysis was done using the Bland-Altman plot and the Cohen Kappa coefficient. Results The mean of the differences between the INR values and the limits of agreement were −0.07 [−0.51 to 0.38] for the Neoplastine CI plus and Neoplastine CI reagents, −0.08 [−1.18 to 1.03] for the Thromborel S and Innovin reagents when the INR was calculated, −0.1 [−1.15 to 0.95] for the Thromborel S and Innovin reagents when the INR was directly calibrated and −0.1 [−0.7 to 0.5] for the Neoplastine CI plus and Thromborel S. Cohen's kappa coefficients were 0.94, 0.76, 0.85 and 0.82, respectively. New findings and conclusion The agreement between the four reagent/instrument combinations was high enough to classify patients as inefficaciously or efficaciously anticoagulated. The data interpretation should always be related to the clinical purpose.
      pubtype: Academic Journal
      doctype:
        research
        tables/charts
        Journal Article
      ougenre: Article
    language: English
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