title: [Multicenter evaluation of the reliability of five blood glucose monitoring systems].
abstract: As part of a tender AP-HP Paris Hospitals, an assessment of the reliability record of five blood glucose monitoring systems (BGMSs) (Optium Xceed (Abbott), Contour TS (Bayer), One Touch Ultra (Lifescan), Stat Strip Xpress (Nova) and Accu Check (Roche) and an evaluation of their sensitivity to changes in hematocrit were conducted in 4 hospitals of Paris. In terms of inaccuracy, all BGMSs have submitted CV repetability under the limits of acceptability. One BGMS (Lifescan) presented a CV of reproducibility outside limit of acceptability (13.1%). The inaccuracy was measured by a comparison method on multiparameter analyser relative to the hexokinase method for two sites, the glucose oxidase for the two others. The coefficients of correlation varied from 0.8405 to 0.9303. However, according to both defined acceptability criteria (absolute value difference between the result acquired on analyzer and those determined with the BGMS), the percentage of results outside acceptability was above 20% for two BGMSs (Abbott and Lifescan). Similarly, a net effect of changes in hematocrit was observed on the results of those two BGMSs. BGMS Nova was the most reliable, because of the correction device for hematocrit and blank substractions owed to interferences. In terms of expertise, BGMSs Nova and Roche have been selected with the best analytical performance and practicability satisfactory. In the future, accreditation with standard NF/EN 22870 requested for point of care testing, will require a close collaboration between biologists and clinicians to establish a system of strict quality control to detect deviations of these BGMSs.
authors.affiliation: Laboratoire de biochimie générale, Hôpital Necker-Enfants-Malades, Paris.
authors.forename: Ismahen
authors.initials: I
authors.lastname: Jday-Daly
authors.forename: Christine
authors.initials: C
authors.lastname: Augereau-Vacher
authors.forename: Claire
authors.initials: C
authors.lastname: De Curraize
authors.forename: Michèle
authors.initials: M
authors.lastname: Fonfrède
authors.forename: Guillaume
authors.initials: G
authors.lastname: Lefevre
authors.forename: Bernard
authors.initials: B
authors.lastname: Lacour
authors.forename: Carole
authors.initials: C
authors.lastname: Hennequin-Le Meur
mesh_terms: D015190:Blood Glucose Self-Monitoring / Q000295:instrumentation*; D006400:Hematocrit; D006801:Humans; D011786:Quality Control