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Diagnostic performance of a point-of-care glucose analyzer in gestational diabetes

Background: Oral glucose tolerance test (oGTT) with laboratory mesurement of venous plasma glucose (VPG) at fasting, 1 and 2 hours after a 75g glucose load is the recommended diagnostic procedure for gestational diabetes mellitus (GDM). The inconvenience of multiple venipunctures and notorious instability of glucose in venous blood samples, together with the complexity of the oGTT procedure seriously compromise the choice of the GDM diagnostic test procedure, particularly in remote and under-resourced areas. Considering the dramatically rising prevalence and recently introduced recommendations for universal screening ofGDM, suitable alternatives for simplifying GDMdiagnostic procedure are urgently needed in order to provide appropriate level of pregnancy health-care and improve patient outcomes. Aim: The aim of this study was to validate the diagnostic performance of the Nova StatStrip Glucose point-of-care (StatStrip) analyzer (Nova Biomedical, USA), designed and aproved for hospital use, in the GDM diagnosis. Considering a lack of defined cut-points for capillary plasma glucose (CPG) in GDM diagnosis, we also aimed to determine a set of StatStrip- specific CPG diagnostic criteria. Methods: After providing informed consent, CPG was sampled and StatStrip glucose measured at fasting (F-CPG), 1- and 2- hour after a 75g oral glucose load. Blood samples for VPG were collected within 5 minutes of respective CPG sampling in heparin tubes, immediately refrigerated, processed and analysed within 30 minutes with the reference laboratory procedure (hexokinase, Olympus AU400, Beckman Coulter, USA). Glycaemic status was classified as either normoglycaemic (NG) or GDM, according toWHO-2013 venous plasma-based criteria.

gestational diabetes, diagnosis, point-of-care glucose

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