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9. FORA COMFORT Blood Glucose Test Strip
ACS042
Accuracy
The table below displays how often FORA COMFORT achieves this target. The
chart is based on a study carried out on 160 patients (each patient was tested six
times which had 960 test results) to see how well FORA COMFORT performed
compared to YSI-2300 reference method results.
Table 1 Accuracy results for glucose concentration < 100 mg/dL (5.55 mmol/L)
Within ±5 mg/dL
(Within ±0.28mmol/L)
Within ±10 mg/dL
(Within ±0.55mmol/L)
Within ±15 mg/dL*
(Within ± 0.83 mmol/L)
57.3% (165/288)
90.3% (260/288)
100% (288/288)
Table 2 Accuracy results for glucose concentration
≧
100 mg/dL (5.55 mmol/L)
Within ±5 %
Within ±10 %
Within ±15 %*
45.7% (307/672)
77.8% (523/672)
95.4% (641/672)
Table 3 Accuracy results for glucose concentrations between 32.3mg/dL
(1.79mmol/L ) to 544.0mg/dL (30.22mmol/L)
Within ±15 mg/dL or ±15%
(Within ±0.83 mmol/L or ±15%)
96.8% (929/960)
Note:
*According to the accuracy criteria of EN ISO 15197: 2015, 95% of all
differences in glucose values (i.e., YSI-2300 reference values minus glucose
values of FORA COMFORT) should be within ±15 mg/dL (0.83 mmol/L) for
glucose concentration < 100 mg/dL (5.55 mmol/L), and within ±15% for glucose
concentration ≥ 100 mg/dL (5.55 mmol/L). When Test Strips results are compared
to the reference values, difference values below 100 mg/dL (5.55 mmol/L) are
expressed in mg/dL or mmol/L, while those above 100 mg/dL (5.55 mmol/L) in
percentage.
User performance
160 subjects were tested with blood samples taken from the fingertip and the
alternative sites, the palm, the forearm and the upper arm. The tables show how
