ForaCare FORA 6 Plus - Page 16

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4. FORA 6 Urine Acid Test Strip
ACS057
Accuracy
Results: Difference Plot Analysis
Number of subjects (N) = 160
TABLE 1 Ratio of samples (capillary whole blood) falling within different bias
ranges
Within ±5 %
Within ±10 %
Within ±15 %
Within ±20 %
64.1%
95.0%
100%
100%
Measurement range: 3.3 ~ 10 mg/dL
Linear Regression: y = 1.0098x + 0.0095, R² = 0.9637, (n=320)
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 %
68.1%
96.9%
100%
100%
Measurement range: 3.3 ~ 10 mg/dL
Linear Regression: y = 1.0036x + 0.0499, R² = 0.9633, (n=160)
Precision
TABLE 3 Precision
Uric Acid Concentration (mg/dL)
LOW
MID
HIGH
Mean
5.1
10.1
15.0
SD.
o.205
0.258
0.438
CV%
4.05%
2.55%
2.92%