PERFORMANCE CHARACTERISTICS
The performance of DIGITAL ACCU-ANSWER® Test Strips has been evaluated both in
laboratory and in clinical studies.
Measurement range: The measurement range of DIGITAL ACCU-ANSWER® System is
1.1 to 33.3mmol/L (20-600mg/dL).
Accuracy: The accuracy of DIGITAL ACCU-ANSWER® System was assessed by
comparing blood glucose results obtained.
Using a reference method. The following results were obtained by 110 diabetic patients.
Table 1 Regression analysis
| slope | 0.9845 |
| y-intercept | 2.97mg/dl |
| correlation coefficient | 0.9819 |
| No. of samples | 110 |
| range tested | 444-446mg/dL |
Figure 1 Regression plot
Table 2 system accuracy results for glucose concentration
<5.5mmol/L (100 mg/dL)
<5.5mmol/L (100 mg/dL)
| Less than±0.28 mmol/L (±5mg/dL) |
Less than±0.55mmol/L (±10mg/dL) | Less than±0.83 mmol/L (±15mg/dL) |
|---|---|---|
| 50/102 (49.0%) | 84/102 (82.3%) | 99/102 (97.1%) |
Table 3 system accuracy results for glucose concentration
≥5.5mmol/L (100 mg/dL)
≥5.5mmol/L (100 mg/dL)
| Less than±5% | Less than±10% | Less than±15% |
|---|---|---|
| 304/558(54.4%) | 465/558(83.3%) | 546/558(97.8%) |
Precision: This study shows that the DIGITAL ACCU-ANSWER® System compare
well with a laboratory method.
| BIOSEN C-line average value |
Meter test average value |
Meter test standard deviation |
Meter test variable coefficient |
|
|---|---|---|---|---|
| sample 1 | 1.92 | 1.99 | 0.103 | 5.2% |
| sample 2 | 4.53 | 4.77 | 0.210 | 4.4% |
| sample 3 | 7.42 | 7.22 | 0.193 | 2.7% |
| sample 4 | 10.64 | 10.71 | 0.377 | 3.5% |
| sample 5 | 18.78 | 17.81 | 0.449 | 2.5% |
This study shows a variability from strip to strip in blood tests of 4.4% or less.
