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Reliability of International Normalized Ratio Results in the CoaguChek Pro II System in a Clinical Setting

Evelyn Cortina-de-la-Rosa1, Raúl Izaguirre-Ávila1, Alejandro Ramírez-Hernández1

  • 1Department of Hematology, National Institute of Cardiology Ignacio Chávez, México City, México.

Clinical and Applied Thrombosis/Hemostasis : Official Journal of the International Academy of Clinical and Applied Thrombosis/Hemostasis
|November 29, 2023
PubMed

Insights

The CoaguChek Pro II, CoaguChek XS Plus, and cobas t 411 systems demonstrate good agreement for measuring prothrombin time/international normalized ratio (PT/INR). These findings support their reliability in clinical settings for accurate PT/INR testing.

Area of Science:

  • Clinical Chemistry
  • Hematology
  • Diagnostic Technology

Background:

  • The National Institute of Cardiology has experience with the CoaguChek XS Plus system for capillary blood prothrombin time/international normalized ratio (PT/INR) analysis.
  • Previous comparisons involved the BCS-XP/Thromborel system.

Purpose of the Study:

  • To assess the reliability and agreement of PT/INR results obtained from the third-generation CoaguChek Pro II system.
  • To compare the CoaguChek Pro II system with the CoaguChek XS Plus system and the cobas t 411 analyzer for both venous and capillary blood samples.

Main Methods:

  • A total of 204 venous and capillary PT/INR measurements were performed.
  • Statistical analyses included Spearman's correlation, Bland-Altman analysis, and concordance analysis to compare the different testing methods.

Main Results:

  • High Spearman's correlation coefficients were observed between all tested systems for venous/capillary INR (ranging from r=0.967 to r=0.994).
  • Good concordance was found among capillary methods (κ=0.888) and between the cobas t 411 and CoaguChek systems (κ=0.696 and κ=0.684).

Conclusions:

  • The CoaguChek Pro II, CoaguChek XS Plus, and cobas t 411 systems show good agreement for PT/INR measurements.
  • These results indicate the reliability of these systems for clinical PT/INR testing using both venous and capillary blood.

Keywords:
anticoagulantsinternational normalized ratiopoint-of-care systemsprothrombin timereproducibility of results

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