A retrospective analysis of discordances between international normalized ratio (INR) self-testing and INR laboratory testing in a pediatric patient population.

Abstract

The lack of quality control procedures for home point-of-care (POC) international normalized ratio (INR) devices is a concern. Concomitant laboratory and POC INR testing may be proposed to overcome the lack of quality control. However, a difference between the POC INR and the laboratory INR is not necessarily due to failure of the POC device. This study aimed to identify variables associated with a significant deviation between the POC INR and the laboratory INR. Children included in this retrospective cohort study performed at least one concomitant laboratory and POC INRs. Clinical and laboratory variables were assessed for an association with significant deviation within pairs of INR. A significant deviation was noted for 30 (15.3%) of the 196 pairs of INR measurements from 124 children. Relative to patients without deviations, patients with deviations were younger (odds ratio =0.91; P=.020), less experienced in the use of POC INR devices (odds ratio =0.89; P=.098), and more likely to have received an INR result from a laboratory using animal thromboplastin (odds ratio =2.81 vs. 0.37 for laboratories using human thromboplastin; P=.016). In a multivariate analysis, younger age and the laboratory's use of animal thromboplastin were associated with significant deviations. Although most children had coherent pairs of INR values, the occurrence of deviations raises the question of the origin of the thromboplastin used in the laboratory and emphasizes the need to provide specific quality control procedures for POC INR devices.