Analytic Performance Evaluation of Blood Monitoring System G400 according to ISO 15197:2013

BACKGROUND: Self-monitoring of blood glucose is an important component of therapy for diabetes mellitus. The aim of this study was to evaluate the analytic performance evaluation of blood monitoring system G400 according to ISO 15197:2013. METHODS: We evaluated the G400 according to the ISO 15197:2013 guideline, we measured precision, accuracy, interference of hematocrit and interfering substances, user performance. RESULTS: Repeatability and intermediate precision of G400 showed standard deviation 2.7–3.8 mg/dL, 2.4–3.6 mg/dL and coefficient of variation 1.9-2.9% and 1.7–3.7%, respectively. Accuracy measured 98–98.5%, satisfied acceptable criteria. Error grid analysis showed that all results of this study were in zone A. Hematocrit between 20% to 60% did not cause interference. Three of 24 interfering substances were not acceptable criteria, and dose-response evaluation was needed. CONCLUSIONS: This study showed that G400 was considered reliable results satisfying the ISO 15197:2013 criteria

Parameters to Guide Retreatment After Initial Intravenous Immunoglobulin Therapy in Kawasaki Disease

BACKGROUND AND OBJECTIVES: We sought to determine parameters to guide the decision of retreatment in patients with Kawasaki disease (KD) who remained febrile after initial intravenous immunoglobulin (IVIG). SUBJECTS AND METHODS: A total of 129 children with KD were studied prospectively. Patients were treated with IVIG 2 to 9 days after the onset of disease. Laboratory measures, such as white blood cell (WBC), percentage of neutrophils, C-reactive protein (CRP), and N-terminal pro-brain natriuretic peptide (NT-proBNP), were determined before and 48 to 72 hours after IVIG treatment. Patients were classified into IVIG-responsive and IVIG-resistant groups, based on the response to IVIG. RESULTS: Of a total of 129 patients, 107 patients (83%) completely responded to a single IVIG therapy and only 22 patients (17%) required retreatment: 14 had persistent fever and 8 had recrudescent fever. There was no significant difference between the groups in age, gender distribution, and duration of fever to IVIG initiation, but coronary artery lesions developed significantly more often in the resistant group than in the responsive group (31.8% vs. 2.8%, p=0.000). Compared with pre-IVIG data, post-IVIG levels of WBC, percentage of neutrophils, CRP, and NT-proBNP decreased to within the normal range in the responsive group, whereas they remained high in the resistant group. Multivariate logistic regression indicated that neutrophil counts, CRP, and NT-proBNP were independent parameters of retreatment. CONCLUSION: Additional therapy at an early stage of the disease should be administered for febrile patients who have high values of CRP, NT-proBNP, and/or neutrophil counts after IVIG therapy.