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. 2023 Jan-Dec:29:10760296231216451.
doi: 10.1177/10760296231216451.

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

Evelyn Cortina-de-la-Rosa  1 , Raúl Izaguirre-Ávila  1 , Alejandro Ramírez-Hernández  1 , María-Oliva Romero-Arroyo  1 , Karen Cortés-Cortés  1
Affiliations

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

Evelyn Cortina-de-la-Rosa et al. Clin Appl Thromb Hemost. 2023 Jan-Dec.

Abstract

The National Institute of Cardiology has previously used the CoaguChek® XS Plus system (Roche Diagnostics International Ltd), comparing capillary blood prothrombin time/international normalized ratio (PT/INR) results with those obtained using BCS-XP/Thromborel (Siemens). We assessed the reliability of PT/INR results using the third-generation CoaguChek Pro II system, the CoaguChek XS Plus system, and cobas® t 411 for citrated plasma analysis. Venous and capillary PT/INR were measured (N = 204). Spearman's correlation, Bland-Altman, and concordance analysis between methods were conducted. Spearman's correlation coefficients between venous/capillary INR were high for CoaguChek Pro II versus CoaguChek XS Plus (r = 0.994), CoaguChek Pro II versus cobas t 411 (r = 0.967), and CoaguChek XS Plus versus cobas t 411 (r = 0.968). Good concordance was observed among capillary methods (concordance coefficient [κ] = 0.888) and remaining relationships (P < .001 for all): cobas t 411 versus CoaguChek XS Plus (κ = 0.696) and cobas t 411 versus CoaguChek Pro II (κ = 0.684). In conclusion, good agreement was observed between CoaguChek Pro II, CoaguChek XS Plus, and cobas t 411.

Keywords: anticoagulants; international normalized ratio; point-of-care systems; prothrombin time; reproducibility of results.

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Conflict of interest statement

Declaration of Conflicting InterestsThe authors declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.

Figures

Figure 1.
Figure 1.
Correlation (center line) and confidence intervals (outer lines) between (a) the CoaguChek Pro II system versus the CoaguChek XS Plus system INR (capillary method vs capillary method); (b) the CoaguChek Pro II system versus the cobas t 411 analyzer INR (capillary method vs venous method); N = 186. Abbreviation: INR, international normalized ratio.
Figure 2.
Figure 2.
Correlation between the CoaguChek Pro II system and the cobas t 411 analyzer INR in (a) patients with an INR <2.0 (sub-anticoagulated); (b) patients with an INR 2.0 to 3.5 (anticoagulated); (c) patients with an INR >3.5 (over-anticoagulated). Abbreviation: INR, international normalized ratio. *INR reference measured in venous plasma on the cobas t 411 analyzer.
Figure 3.
Figure 3.
Bland-Altman or difference plots in (a) patients with an INR <2.0 (sub-anticoagulated); (b) patients with an INR 2.0 to 3.5 (anticoagulated); (c) patients with an INR >3.5 (over-anticoagulated), for the venous method (cobas t 411 analyzer) versus capillary method (left panels: the CoaguChek XS Plus system; right panels: the CoaguChek Pro II system). Abbreviations: ACO, anticoagulated; INR, international normalized ratio; OverACO, over-anticoagulated; SD, standard deviation.
Figure 4.
Figure 4.
Bland-Altman or difference plots of the cobas t 411 analyzer (venous method vs (a) the CoaguChek XS Plus system and (b) the CoaguChek Pro II system (capillary INR). The vertical red dotted line indicates the INR value (3.5) beyond which anticoagulation is necessary to reduce the risk of bleeding. Abbreviations: INR, international normalized ratio; SD, standard deviation.
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