Validity of two point-of-care glucometers in the diagnosis of neonatal hypoglycemia

Abstract

Objective: To estimate validity of two point-of-care glucometers for the diagnosis of neonatal hypoglycemia and to determine the glucometer's cut-off values for which standard laboratory confirmatory test are no longer needed. Design: Prospective study. Settings: A tertiary care, university hospital in Bangkok, Thailand. Participants: The study included 180 blood specimens from 166 high-risk neonates aged between 1-24 hours. Results: On average, most of the blood glucose read-outs from the Nova StatStrip and SureStep were higher than laboratory plasma glucose throughout the glucose range with mean differences (SD) of 11.2 (8.4) mg/dL and 13.7 (6.8) mg/dL, respectively. Sensitivity of Nova StatStrip and SureStep were 62% and 53.3%, respectively. Specificity and positive predictive value of both glucometers were 100%. Negative predictive values of both glucometers were approximately 85%. The cut-off levels with 100% negative predictive values were 63 mg/dL and 62 mg/dL for Nova StatStrip and SureStep, respectively. Conclusions: None of the glucometers in this study has sufficient validity to replace laboratory testing in diagnosing hypoglycemia. Confirmatory plasma glucose for diagnosis of hypoglycemia is needed when POC readings are between 39 and 63 mg/dL for Nova StatStrip and between 39 and 62 mg/dL for SureStep.