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Diagnosing gestational diabetes mellitus: a new challenging task for the Nova-StatStrip POC glucose analyzer

Accurate and rapid fasting plasma glucose (FPG) measurement is critical for the diagnosis of gestational diabetes mellitus (GDM). Studies from different populations revealed the majority of GDM patients classified according to recently recommended WHO-2013 FPG-criterion (5.1-6.9 mmol/l), and 75g oral glucose tolerance test (oGTT) is required only for diagnosing GDM with FPG values <5, 1 mM. The aim of this study was to assess the utility of a point-of-care (POC) glucose analyzer designed for hospital use (StatStrip Glucose, Nova Biomedical, USA), for the diagnosis of GDM. Methods: Fasting venous and capillary blood samples were taken from consenting subjects, referred to our clinic for the classification of glycaemia in pregnancy. Sample collection and testing was carried out within 5 minutes for the reference laboratory- (hexokinase, Olympus AU400, Beckman Coulter, USA) and StatStrip-glucose measurement, respectively. A 75g-oGTT was performed in all subjects and their glycaemic status classified as either normal or GDM, according to WHO-2013 venous plasma-based criteria. Regarding well-known difference between the capillary and venous plasma glucose concentrations in post-prandial conditions, and the lack of sample type- specific GDM diagnostic criteria, StatStrip diagnostic accuracy was validated according to the FPG-criterion only. Results: Out of 166 pregnant women included in the study [median age: 31 years (range 18-42)], 51 (30.9%) were classified as GDM, with 59% GDM- cases (n=31) diagnosed according to FPG- criterion. Bland- Altman analysis revealed a slight, but significant bias between laboratory and StatStrip-FPG [mean:-0.27, range(±1, 96SD):-0.72-0, 19 mM], which was not dependent on neither hematocrit nor WBC (P=0.5894 and P=0.2682, respectively). When optimal diagnostic cutoff for StatStrip-FPG was applied (>5, 2 mM, 91, 7% specificity, 93, 7% sensitivity, ROC-analysis), a good agreement between the methods regarding GDM diagnosis was shown (weighted kappa=0, 772). Conclusion: Our data reveal that more than 80% oGTT procedures for GDM diagnosis could be avoided, if timely FPG-value of sufficient accuracy for the reliable diagnostic decision is available. StatStrip POCT glucose analyzer could serve as a valuable tool in attaining this goal.

gestational diabetes; diagnosis; POCT; glucose meter

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