13/65
2. FORA 6 Blood Glucose, Hematocrit and Hemoglobin Test Strip
ACS051
(1)
BG
Accuracy
The table below displays how often FORA 6 achieves this target. The chart is
based on a study carried out on 100 patients (each patient was tested six times
which resulted in 600 test results) to see how well FORA 6 performed compared
to Cobas Integra® 400 plus 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)
33.3% (52/156)
73.7% (115/156)
98.7% (154/156)
Table 2 Accuracy results for glucose concentration ≥ 100 mg/dL (5.55 mmol/L)
Within ±5 %
Within ±10 %
Within ±15 %*
69.1% (307/444)
93.9% (417/444)
99.5% (442/444)
Table 3 Accuracy results for glucose concentrations between 40 mg/dL (2.22
mmol/L ) to 456 mg/dL (25.3 mmol/L)
Within ±15 mg/dL or ±15%
(Within ±0.83 mmol/L or ±15%)
99.3% (596/600)
Note:
* According to the accuracy criteria of EN ISO 15197: 2015, 95% of all
differences in glucose values (i.e., Cobas Integra® 400 plus reference values
minus glucose values of FORA 6) 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 thos above 100 mg/dL (5.55 mmol/L) are 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
well FORA 6 performed compared to Cobas C311 reference method results.
