Clinical evaluation of bionime rightest GM310 biosensors with a simplified electrode fabrication for alternative-site blood glucose tests.

BACKGROUND Most processes for fabricating biosensors applied to screen-printed carbon electrodes (SPCEs) are complex. This study presents a novel one-step process for manufacturing electrodes for injection-molding biosensors. METHODS During the sensor-fabrication process, barrel-plated gold electrodes were inserted into an injection-molded base. The electrode directly touched the electrical contact of a meter. We analyzed technical measurements for this biosensor, including tests of the measurement range, within-run imprecision, and between-meter imprecision. In clinical trials, experienced technicians tested 3 alternative sites (fingertip, palm, and arm). The results were simultaneously compared with plasma values obtained with the hexokinase method on the Olympus AU640 instrument. Analytical results were evaluated according to International Standards Organization 15197 (ISO 15197:2003) criteria and by Clarke error grid analysis (EGA), and CVs were calculated to evaluate within-run imprecision. RESULTS The glucose measurement range was 0.6- 33.3 mmol/L (y = 0.96x + 0.07 mmol/L; r(2) = 0.9977). The CVs in the within-run imprecision test were 1.7%-3.5%, and the overall CV was 2.1%, indicating good reproducibility of results. The Student t-tests of mean values from 5 meters revealed statistically insignificant differences (P > 0.05). In clinical trials, the agreement of the Rightest GM310 meter results with those of a laboratory method complied with ISO 15197:2003 criteria. In the EGA, 100% of the values were within the acceptable zones (A + B), and the proportion of values within zone A exceeded 95%. CONCLUSIONS The Bionime Rightest GM310 meter applied a simplified process for biosensor fabrication and displayed acceptable performance for monitoring glucose concentrations at alternative test sites.