24/65
well FORA COMFORT performed compared to YSI-2300 reference method
results.
Table 1 Difference distribution for glucose concentration < 100 mg/dL (5.55
mmol/L)
Tested sites
Difference within
±5mg/dL
Difference within
±10mg/dL
Difference within
±15mg/dL
Fingertip
29/46 (63.0%)
41/46 (89.12%)
46/46 (100%)
Palm
23/57 (40.4%)
46/57 (80.7%)
57/57 (100%)
Forearm
13/57 (22.8%)
44/57 (77.2%)
57/57 (100%)
Upper arm
17/57 (29.8%)
48/57 (84.2%)
57/57 (100%)
Table 2 Dif
ference distribution for glucose concentration ≥ 100 mg/dL (5.55
mmol/L)
Tested sites
Difference within
±5mg/dL
Difference within
±10mg/dL
Difference within
±15mg/dL
Fingertip
39/114 (34.2%)
80/114 (70.2%)
110/114 (96.5%)
Palm
36/103 (35.0%)
73/103 (70.9%)
102/103 (99.0%)
Forearm
24/103 (23.3%)
70/103 (68.0%)
100/103 (97.1%)
Upper arm
22/103 (21.4%)
61/103 (59.2%)
98/103 (95.1%)
Precision
In both intermediate precision and repeatability tests, the standard deviation (SD)
is within 5 mg/dL (0.28 mmol/L) for each glucose concentration < 100 mg/dL
(5.55 mmol/L) and the coefficient of variation (CV) is less than 5% for each
glucose concentratio
n ≥ 100 mg/dL (5.55 mmol/L).