Point-of-care testing for coagulation function: CoaguChek® XS System versus standard laboratory testing in pediatric patients with normal and abnormal coagulation function

Abstract

Purpose: Intraoperative abnormalities of coagulation function may occur for various reasons. In most scenarios, treatment is directed by laboratory parameters. Unfortunately, standard laboratory testing may take 1–2 h. The purpose of the current study was to evaluate a point-of-care testing device (CoaguChek® XS System) in pediatric patients. Methods: Patients ranging in age from 2 to 18 years, undergoing posterior spinal fusion (PSF) or cardiac surgery using cardiopulmonary bypass (CPB) were eligible for inclusion. After CPB and/or the surgical procedure, 2.8 ml of blood was obtained and simultaneously tested on both the standard laboratory apparatus and the CoaguChek® XS System. Results: The study cohort consisted of 100 patients (50 PSF and 50 cardiac cases) with 13 cases excluded, leaving 87 patients (49 PSF and 38 cardiac cases) for analysis. In PSF cases, reference laboratory international normalized ratio (INR) ranged from 0.98 to 1.77 while CoaguChek® XS INR ranged from 1.0 to 1.3. The correlation coefficient was 0.69. The results of the Bland–Altman analysis showed a bias of 0.09, precision of 0.1, and 95% limits of agreement ranging from −0.11 to 0.28. In cardiac cases, reference INR ranged from 1.68 to 14.19, while CoaguChek® XS INR ranged from 1.4 to 7.9. The correlation coefficient was 0.35. The results of the Bland–Altman analysis showed a bias of −1.8, precision of 2.1, and 95% limits of agreement ranging from −6.0 to 2.4. Conclusions: INR values obtained from CoaguChek® XS showed a moderate correlation with reference laboratory values within the normal range. However, in the presence of coagulopathy, the discrepancy was significantly greater, thereby making the CoaguChek® XS clinically unreliable.