Evaluation of an electrochemical biosensor for uric acid measurement in human whole blood samples.

BACKGROUND: Uric acid measurement has become increasingly important, and electrochemically modified detection method based portable devices hold a dominant position in the market for point of care and self-monitoring of uric acid blood levels. However, there has been a lack of detailed performance evaluation of the electrochemical detection devices that are currently being used in professional health care facilities and for home self-monitoring of uric acid. METHODS: A commercially available uric acid monitoring system that is chemically modified to reduce interference was evaluated via clinical evaluation for its performance and interference as compared to a centralized laboratory instrument. RESULTS: Precision was within ±3.1% for 3 levels of control solutions and whole blood samples. A range from 30 to 55% was acceptable for the measurement of hematocrit levels in whole blood samples. There was no interference for the potential substances at their high therapeutic levels. Hemolyzed samples of up to 75 g/l showed no interference with test results obtained by the BeneCheck system, while a -45.9% bias% was obtained during testing of the same samples by a spectrophotometer. Clinical evaluation showed that >95% of tests were within ±20% bias% compared to a centralized instrument in hospitals. CONCLUSION: The uric acid monitoring system was suitable for use in monitoring or screening uric acid concentration for home users or professionals.