Accu-Chek Performa Instrucciones De Uso página 69

306_33481_PerfManLAapacEN.qxp 3/9/07 8:42 AM Page 67
Performance Analysis
The performance data for the Accu-Chek Performa system (Accu-Chek Performa meter with
Accu-Chek Performa test strips) were obtained using capillary blood from diabetic patients
(method comparison, accuracy), venous blood (repeatability) and control solution
(reproducibility). The system is calibrated with venous blood containing various levels of glucose.
The reference values are obtained using the hexokinase method. For method comparison, the
results were compared with results obtained using the hexokinase method with deproteinization
(automatic analyzer). The hexokinase method is traceable to an NIST standard.
The Accu-Chek Performa system meets the ISO 15197 requirements.
Measuring Principle
The enzyme on the test strip, glucose dehydrogenase, in the presence of the coenzyme
(PQQ), converts the glucose in the blood sample to gluconolactone. This reaction creates a
harmless DC electrical current that your meter interprets for your blood glucose. The sample
and environmental conditions are also evaluated using a small AC signal.
Blood glucose concentrations may be measured in whole blood or plasma. Although you
always apply whole blood to the test strip, your meter displays blood glucose results that 67
relate to plasma. Please refer to the package insert for information on how the system
works, on the test principle and on reference methods.