15/65
3. FORA 6
β
-Ketone Test Strip
ACS053
Accuracy
The table below displays how often FORA achieves this target. The chart is
based on a study carried out on 160 patients (each patient was tested three
times which resulted in 480 test results) to see how well FORA performed
compared to
β
-Hydroxybutyrate LiquiColor® reference method results.
Capillary samples
(n=480)
β-ketone concentration (mmol/L)
Regression analysis
Range: 0.10 to 6.75
Mean: 1.13
y = 0.9997x - 0.0153,
R² = 0.9912
Venous samples
(n=480)
β-ketone concentration (mmol/L)
Regression analysis
Range: 0.10 to 6.75
Mean: 1.12
y = 0.9926x - 0.0554,
R² = 0.9772
Precision
In repeatability test, the standard deviation (SD) is within 0.1 mmol/L for each
β
-
Ketone concentration < 1 mmol/L and the coefficient of variation (CV) is less than
7.5% for each
β
-
Ketone concentration ≥ 1 mmol/L.
