Interference Studies with Two Hospital-Grade and Two Home-Grade Glucose Meters

Background: Interference studies of four glucose meters ( Nova Biomedical [Waltham, MA] StatStrip (TM) [hospital grade], Roche Diagnostics [Indianapolis, IN] Accu-Chek Aviva (R) [home grade], Abbott Diabetes Care [Alameda, CA] Precision FreeStyle Freedom (R) [home grade], and LifeScan [Milpitas, CA] SureStep Flexx (R) [hospital grade]) were evaluated and compared to the clinical laboratory plasma hexokinase reference method (Roche Hitachi 912 (R) chemistry analyzer). These meters were chosen to reflect the continuum of care from hospital to home grade meters commonly seen in North America. Methods: Within-run precision was determined using a freshly prepared whole blood sample spiked with concentrated glucose to give three glucose concentrations. Day-to-day precision was evaluated using aqueous control materials supplied by each vendor. Common interferences, including hematocrit, maltose, and ascorbate, were tested alone and in combination with one another on each of the four glucose testing devices at three blood glucose concentrations. Results: Within-run precision for all glucose meters was <5% except for the FreeStyle (up to 7.6%). Between-day precision was <6% for all glucose meters. Ascorbate caused differences (percentage change from a sample without added interfering substances) of >5% with pyrroloquinolinequinone (PQQ)-glucose dehydrogenase-based technologies (Aviva and Freestyle) and the glucose oxidase-based Flexx meter. Maltose strongly affected the PQQ-glucose dehydrogenase-based meter systems. When combinations of interferences (ascorbate, maltose, and hematocrit mixtures) were tested, the extent of the interference was up to 193% (Aviva), 179% ( FreeStyle), 25.1% (Flexx), and 5.9% (StatStrip). The interference was most pronounced at low glucose (3.9-4.4 mmol/L). Conclusions: All evaluated glucose meter systems demonstrated varying degrees of interference by hematocrit, ascorbate, and maltose mixtures. PQQ-glucose dehydrogenase-based technologies showed greater susceptibility than glucose oxidase-based systems. However, the modified glucose oxidase-based amperometric method (Nova StatStrip) was less affected in comparison with the glucose oxidase-based photometric method (LifeScan SureStep Flexx).