ForaCare FORA 6 Plus - Page 17

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5. FORA 6 Total Cholesterol Test Strip
ACS055
Accuracy
Results: Difference Plot Analysis
Number of subjects (N) = 320
TABLE 1 Ratio of samples (capillary whole blood) falling within different bias
ranges
Within ±5 %
Within ±10 %
Within ±15 %
Within ±20 %
80.3%
99.1%
100%
100%
Measurement range: 129 ~ 399 mg/dL
Linear Regression: y = 0.9777x + 1.9945, R² = 0.9724, (n=640)
User performance
Results: Difference Plot Analysis
Number of subjects (N) = 160
TABLE 2 Ratio of samples (capillary whole blood) falling within different bias
ranges
Within ±5 %
Within ±10 %
Within ±15 %
Within ±20 %
68.4%
98.8%
100%
100%
Measurement range: 129 ~ 399 mg/dL
Linear Regression: y = 0.9753x + 2.0318, R² = 0.9693, (n=320)
Precision
TABLE 3 Precision
FORA 6 Plus
Interval 1
Interval 12
Mean
140.0
236.8
SD
9.81
16.63
CV%
7.01%
7.02%
FORA 6 Connect
Interval 1
Interval 12
Mean
137.6
241.5
SD
10.12
16.75
CV%
7.35%
6.94%