Accuracy of CoaguChek XS for point-of-care antithrombotic monitoring in children with heart disease.
The CoaguChek XS international normalized ratio (INR) assay was compared to INR assay by a standard laboratory method in children with heart disease on anticoagulant therapy. The data comprised 120 pairs of INR values for 42 patients (age <16 yr) who attended a cardiology clinic between 1 May 2007 and 30 January 2008. Parallel INR assays by the CoaguChek XS and the standard method were performed within 1 hr by a single qualified technician and the paired results were evaluated by linear regression and Bland-Altman analysis. The mean difference in the INR values was -0.08 +/- 0.04 units (p = 0.63); the difference between the two results was consistently <0.5 INR units. The slope of the regression line was 0.98 (95% CI: 0.96 to 1.01) and the y-intercept was 0.014 (95% CI: -0.01 to 0.04). In the Bland-Altman analysis, the mean difference in INR between the two methods was 0.08 units and values for 99.4% of the patients fell within the limit of agreement (-0.17 to 0.28 units). In summary, INR assays in children by the CoaguChek XS device are as accurate as the standard method, but faster and more convenient.
Moon
Ju Ryoung
JR
Cardiac & Vascular Center, Samsung Medical Center, Sungkyunkwan University School of Medicine, Gangnam-gu, Seoul, Korea 135-710.
Jeong
Soo In
SI
Huh
June
J
Lee
Heung Jae
HJ
Park
Pyo Won
PW
Kang
I-Seok
IS
D000293:Adolescent; D000925:Anticoagulants / Q000627:therapeutic use*; D002648:Child; D002675:Child, Preschool; D016903:Drug Monitoring / Q000592:standards*; D005260:Female; D006331:Heart Diseases / Q000175:diagnosis / Q000188:drug therapy*; D006801:Humans; D019934:International Normalized Ratio / Q000295:instrumentation* / Q000379:methods; D008297:Male; D019095:Point-of-Care Systems / Q000592:standards*; D011517:Prothrombin Time; D012015:Reference Standards; D016896:Treatment Outcome; D014859:Warfarin / Q000627:therapeutic use*
D000925:Anticoagulants; D014859:Warfarin