PERFORMANCE EVALUATIONS:
Precision
1. Laboratory Precision: To assess the repeatability
Mean | 2.9 mmol/L | 7.4 mmol/L | 9.1 mmol/L | 14.7 mmol/L | 23.7 mmol/L |
%CV | 8.9% | 4.1% | 4.4% | 3.8% | 2.9% |
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2. Control Testing Precision: An imprecision study of the Ascensia® BREEZE ™ System was conducted at two diabetes clinics. In each location, 50 lay persons with diabetes tested the low, normal and high control solutions in duplicate using the meter system. A different lot of test strips was used in each of the two locations. The table below shows the total standard deviations (SD) and coefficients of variation (CV), which include the within run and between run / day variations.
Low Control Solution
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| Total | Total |
Strip |
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Lot | Operator | Assays | (mmol/L) | (mmol/L) | (%) |
A | Lay User (n=50) | 100 | 4.272 | 0.267 | 6.2 |
B | Lay User (n=50) | 100 | 4.100 | 0.244 | 6.0 |
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