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. 2007 Jan;23(1):47-50.
doi: 10.1016/s0828-282x(07)70212-x.

Validity of CoaguChek S for home monitoring of anticoagulant therapy in pediatrics

James Hill  1 , Sébastien Perreault, Michel Dorval
Affiliations

Validity of CoaguChek S for home monitoring of anticoagulant therapy in pediatrics

James Hill et al. Can J Cardiol. 2007 Jan.

Abstract
in English, French

Background: CoaguChek S (Roche Diagnostics, Canada) is a portable device designed to monitor international normalized ratio (INR) by capillary puncture. Although the device is used in pediatrics, no study has evaluated its validity in patients of this population.

Objective: To evaluate the validity of CoaguChek S as an in-home INR monitor in patients younger than 18 years of age.

Methods: Data were based on 129 INR pairs collected from nine patients younger than 18 years of age followed up at an anticoagulation clinic between March 1, 2000, and January 19, 2004. The INRs from both the laboratory and CoaguChek S were used to evaluate concordance between the two methods using the intraclass correlation coefficient.

Results: The overall intraclass correlation coefficient between the CoaguChek S and the laboratory was 0.75 (95% CI 0.66 to 0.82). On average, CoaguChek S underestimated INRs by 0.11+/-0.54 units compared with those of the laboratory. INRs of 3.5 units and higher obtained with CoaguChek S were, on average, 0.49+/-1.09 units higher than those obtained in the laboratory.

Conclusions: CoaguChek S appears to be a valid instrument for in-home INR monitoring for most patients younger than 18 years of age, with INR targets of 2.0 to 3.0 followed up by an anticoagulant therapy clinic's program. However, caution must be used when interpreting INRs higher than 3.5. Parents should perform a second test to confirm all CoaguChek S INR results higher than 4.0.

CONTEXTE :: Le CoaguChek S (Roche Diagnostics, Canada) est un appareil portatif permettant d’obtenir le rapport normalisé international (RNI) par ponction capillaire. Bien que cet appareil soit utilisé en pédiatrie, aucune étude n’a été effectuée pour évaluer sa validité chez cette population.

OBJECTIF :: Évaluer la validité du CoaguChek S utilisé à domicile pour monitorer le RNI chez les patients de moins de 18 ans.

MÉTHODOLOGIE :: Les données proviennent de 129 paires de RNI colligés chez neuf patients de moins de 18 ans, suivis par une clinique d’anticoagulothérapie entre le 1er mars 2000 et le 19 janvier 2004. Toutes les paires de RNI obtenus par laboratoire et CoaguChek S ont été retenues pour évaluer la concordance entre les deux méthodes, au moyen du coefficient de corrélation intraclasse.

RÉSULTAT :: Le coefficient de corrélation intraclasse global entre le CoaguChek S et le laboratoire est de 0,75 (intervalle de confiance à 95 % = 0,66–0,82). En moyenne, le CoaguChek S sous-estime le RNI de 0,11±0,54 unité par rapport au laboratoire. Les RNI de 3,5 et plus obtenus par CoaguChek S sont en moyenne 0,49±1,09 unité plus élevés que ceux obtenus en laboratoire.

CONCLUSION :: En somme, le CoaguChek S semble être un instrument valide pour le suivi des RNI à domicile de la plupart des patients de moins de 18 ans suivis dans le cadre d’un programme de clinique d’anticoagulothérapie pour qui un RNI visé se situe entre 2.0 et 3.0. Toutefois, il faut être vigilant dans l’interprétation des RNI supérieurs à 3,5. Les parents devraient refaire un deuxième test si le RNI obtenu est supérieur à 4,0, afin de confirmer le résultat.

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Figures

Figure 1)
Figure 1)
Relationship between international normalized ratios (INRs) obtained by CoaguChek S (Roche Diagnostics, Canada) and the laboratory
See this image and copyright information in PMC

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