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Clinical Study for Blood Glucose
The VivaChek™ Blood Glucose and β-Ketone Monitoring System was tested by
352 lay persons using capillary whole blood samples and three VivaChek™ Blood
Glucose test strip lots. The results were compared to the YSI Model 2300 STAT
PLUS Glucose Analyzer. The tables below show how well the two methods
compared.
Table 1-Linear Regression Results
Slope
1.0083
Y-Intercept
-1.9367 mg/dL
Correlation coefficient (R)
0.9982
Number of sample
352
Range tested
39.3 ~ 492.6 mg/dL
Table 2-Consumers Accuracy Results
The numbers and percentages represented in this table are the number of meter
results compared to a laboratory result.
Difference range between the true
blood glucose level and the
VivaChek™ Blood Glucose and
β-Ketone meter result.
Within ±5%
Within ±10% Within ±15% Within ±20%
The percent (and number) of
meter results that match true
blood glucose level within x%
72.7%
(256/352)
98.3%
(346/352)
100%
(352/352)
100%
(352/352)
Clinical Study for Blood β-Ketone
The VivaChek™ Blood Glucose and β-Ketone monitoring system was tested by
101 lay persons using capillary blood samples and three VivaChek™ Blood
β-Ketone test strip lots. The results were compared to the Randox RX Daytona
Plus Chemistry Analyzer. The tables below show how well the two methods
compared.
Table 1-Linear Regression Results
Slope
1.0037
Y-Intercept
0.015 mmol/L
Correlation coefficient(R)
0.9928
Number of sample
101
Range tested
0.10 ~ 5.37 mmol/L
Table 2-Consumers Accuracy Results
The numbers and percentages represented in this table are the number of meter
results compared to a laboratory result.
For Blood β-Ketone Concentration ≥1.5 mmol/L
Difference range between the true
blood β-ketone level and the Within ±5%
Within ±10% Within ±15% Within ±20%
Accurate Results
(Meter result is +/-15% of laboratory result)
352 out of 352 (100% of results)
More Accurate Results
(Meter result is +/-10% of laboratory result)
346 out of 352 (98.3% of results)
Most Accurate Results
(Meter result is +/-5% of laboratory result)
256 out of 352 (72.7% of results)
