Analytical validation of four POC glucometers (CROSBI ID 639262)
Prilog sa skupa u časopisu | sažetak izlaganja sa skupa | međunarodna recenzija
Podaci o odgovornosti
Ćelap, Ivana ; Krtanjek, Sanja ; Vrkić, Nada
engleski
Analytical validation of four POC glucometers
POC devices for measuring blood glucose are widely used in hospital settings as a convenient way to rapidly manage patient therapy. However, selection of the glucometers for hospital use must be carefully provided since numerous glucose meters are available on the market rarely achieve analytical performance goals given by ADA or IFCC. The aim was to investigate analytical performance of four glucometers versus reference laboratory method. Glucometers of four manufacturers [FreeStyle Optimum Neo (Abbott Diabetes Care Inc., Almeda, CA, USA), Bionime GM550 (Bionime GmbH, Switzerland), On-Call Vivid (ACON Laboratories Inc., San Diego, CA, USA) and Element (Infopia Co Ltd, Korea)] were validated. Laboratory glucose was measured with the hexokinase method on Architect c2000 (Abbott Laboratories, Abbott Park, IL, USA). Venous blood was drawn from 30 T2DM patients and healthy volunteers in Li- heparin vacutainers (Greiner Bio-One, Kramsmünster, Austria). Capillary blood glucose was determined on all glucometers for each patient after venous blood sampling. Venous glucose was determined immediately after venipuncture. Results of imprecision were: FreeStyle 6.7% ; Vivid 4.4% ; Element 4.0% ; GM550 3.3%. Relative mean biases between glucometer and reference method were: Freestyle 9.1% ; GM550 15% ; Vivid 9.1% ; Element 12.2%. Passing- Bablok regression analysis have shown systematic shift for Element (y=0.751553 (0.03500-1.7000)+0.965839 (0.8333-1.1000)) and systematic and proportional difference for GM550 (y=1.170588 (0.9122-1.3955)+0.764706 (0.7273- 0.8049)). Error grid analysis showed 100% results in A zone for FreeStyle and Vivid while Element and GM550 showed 81% and 94% results in Zone A, respectively. Results of the study showed satisfactory analytical performance for only two devices, FreeStyle and Vivid.
glucometers; analytical validation
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Podaci o prilogu
eA331-eA331.
2016.
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objavljeno
Podaci o matičnoj publikaciji
Clinical chemistry and laboratory medicine
Plebani, Mario
Berlin: Walter de Gruyter
1434-6621
Podaci o skupu
4th Joint EFLM-UEMS Congress “Laboratory Medicine at the Clinical Interface”
poster
21.09.2016-24.09.2016
Varšava, Poljska
Povezanost rada
Kliničke medicinske znanosti, Farmacija