Naslov
Analytical validation of four POC glucometers

Autori
Ćelap, Ivana ; Krtanjek, Sanja ; Vrkić, Nada

Vrsta, podvrsta i kategorija rada
Sažeci sa skupova, sažetak, znanstveni

Izvornik
Clinical Chemistry and Laboratory Medicine / Plebani, Mario - Berlin : Walter de Gruyter, 2016, EA331-eA331

Skup
4th Joint EFLM-UEMS Congress “Laboratory Medicine at the Clinical Interface”

Mjesto i datum
Varšava, Poljska, 21.09.2016. - 24.09.2016

Vrsta sudjelovanja
Poster

Vrsta recenzije
Međunarodna recenzija

Ključne riječi
glucometers; analytical validation

Sažetak
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.

Izvorni jezik
Engleski

Znanstvena područja
Kliničke medicinske znanosti, Farmacija

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