title: Validation of Point-of-Care Glucose Testing for Diagnosis of Type 2 Diabetes.
abstract: Point-of-care (POC) glucose technology is currently considered to be insufficiently accurate for the diagnosis of diabetes. The objective of this study was to investigate the diagnostic accuracy of an innovative, interference-resistant POC glucose meter (StatStrip glucose hospital meter, Nova Biomedical, USA) in subjects with a previous history of dysglycaemia, undergoing a 75 g diagnostic oral glucose tolerance test (oGTT). Venous and capillary blood sampling for the reference laboratory procedure (RLP) and POC-glucose measurement was carried out at fasting and 2 h oGTT, and categories of glucose tolerance were classified according to 2006 WHO diagnostic criteria for the respective sample type. We found an excellent between-method correlation at fasting (r = 0.9681, P < 0.0001) and 2 h oGTT (r = 0.9768, P < 0.0001) and an almost perfect diagnostic agreement (weighted Kappa = 0.858). Within a total of 237 study subjects, 137 were diagnosed with diabetes with RLP, and only 6 of them were reclassified as having glucose intolerance with POC. The diagnostic performance of POC-fasting glucose in discriminating between the normal and any category of disturbed glucose tolerance did not differ from the RLP (P = 0.081). Results of this study indicate that StatStrip POC glucose meter could serve as a reliable tool for the diabetes diagnosis, particularly in primary healthcare facilities with dispersed blood sampling services.
authors.affiliation: Department of Laboratory Medicine, Institute of Medical Biochemistry and Laboratory Medicine, Merkur University Hospital, 10000 Zagreb, Croatia.
authors.forename: Marijana
authors.initials: M
authors.lastname: Vučić Lovrenčić
authors.affiliation: Department of Laboratory Medicine, Institute of Medical Biochemistry and Laboratory Medicine, Merkur University Hospital, 10000 Zagreb, Croatia.
authors.forename: Vanja
authors.initials: V
authors.lastname: Radišić Biljak
authors.affiliation: Department of Laboratory Medicine, Institute of Medical Biochemistry and Laboratory Medicine, Merkur University Hospital, 10000 Zagreb, Croatia.
authors.forename: Sandra
authors.initials: S
authors.lastname: Božičević
authors.affiliation: Vuk Vrhovac University Clinic, Merkur University Hospital, 10000 Zagreb, Croatia.
authors.forename: Edita
authors.initials: E
authors.lastname: Pape-Medvidović
authors.affiliation: Vuk Vrhovac University Clinic, Merkur University Hospital, 10000 Zagreb, Croatia.
authors.forename: Spomenka
authors.initials: S
authors.lastname: Ljubić