12. Expected Values
1
Reference
Avital 6276 meter gives plasma equivalent results.
Before eating < 5.6 mmol/L
Two hours after meals <
7.8 mmol/L
Blood glucose levels normally will vary from time to time
depending on food intake, medication dosages, health, stress or
exercise. Consult your physician or healthcare professional for
the target glucose value appropriate for you.
Expected plasma blood glucose values for normal, nondiabetic
adults are as follows.
22
13.Performance Evaluation Data
System Accuracy (method comparison)
Capillary blood study: In a study conducted with the
Avital 6276
meter
system at one physician site with capillary blood samples
from patient's finger and palm, the following results were
obtained. Data across the entire reportable range meet the
acceptance criteria of >95% of individual values within
±
0.83
mmol/L (
±
15 mg/dL) of the reference values at glucose
concentration < 5.55 mmol/L (<100 mg/dL) and within
±
15% at
glucose concentration
≧
5.55 mmol/L (
≧
100 mg/dL).
Precision
The CV(%) is less than 5% in both intermediate measurement
precision and repeatability.
Sample
Source
Finger 167/264 (63.3%) 240/264 (90.9%) 257/264 (97.3%)
Palm 165/264 (62.5%) 234/264 (88.6%) 258/264 (97.7%)
Results for glucose concentration < 5.55 mmol/L (<100 mg/dL)
Within
±
0.28 mmol/L
(within
±
5 mg/dL)
Within
±
0.56 mmol/L
(within
±
10 mg/dL)
Within
±
0.83mmol/L
(within
±
15 mg/dL)
Results for glucose concentration
≧
5.55 mmol/L (
≧
100 mg/dL)
Sample
Source
Finger 416/636 (65.4%) 581/636 (91.4%) 621/636 (97.6%)
Palm 394/636 (61.9%) 577/636 (90.7%) 621/636 (97.6%)
Within
%
± 5
Within
%
± 10
Within
%
± 15
User Performance
A study evaluating glucose values from fingertip and palm capillary
blood samples and obtained by 137 lay persons showed the following results:
100 % within ±0.83 mmol/L (±15 mg/dL) of the medical laboratory values at
glucose concentrations <5.55 mmol/L (100 mg/dL), and more than 99 %
within ±15 % of the medical laboratory values at glucose concentrations
at
≧
5.55 mmol/L (100 mg/dL).
