Bayer HealthCare Blood Glucose Meter manual Technical Information

Technical Information:

Accuracy

The accuracy of the Ascensia CONTOUR Blood Glucose Monitor- ing System has been assessed in a correlation study conducted by healthcare professionals. In this study, 108 fresh capillary blood specimens were tested with the Ascensia CONTOUR Blood Glucose Monitoring System by 108 untrained people with dia- betes using three test strip lots. The reference measurement was done on the YSI Glucose Analyzer. Ascensia CONTOUR data compare well with the results from the YSI method.

Regression Statistics (Plasma/Serum Reference): plasma reference glucose range: 4.2 to 22.0 mmol/L

		Correlation
Lot	y =	Coefficient
		(r)
1	1.02x – 0.01 mmol/L	0.972
2	1.03x – 0.24 mmol/L	0.963
3	0.95x – 0.02 mmol/L	0.974

Precision

A study was conducted with the Ascensia CONTOUR Blood Glucose Monitoring System with five heparinized whole blood specimens with glucose levels from 2.2 to 18.0 mmol/L. Multiple replicates (n=100) were tested using mul- tiple Ascensia CONTOUR Blood Glucose Meters and one lot of Ascensia MICROFILL Blood Glucose Test Strips. The fol- lowing precision results were obtained:

Plasma/Serum:

			Coefficient
Mean		SD	of
			variation
2.1 mmol/L		0.10 mmol/L	4.8%
5.6 mmol/L		0.28 mmol/L	5.1%
6.5 mmol/L		0.24 mmol/L	3.7%
11.4 mmol/L		0.38 mmol/L	3.3%
18.1 mmol/L		0.65 mmol/L	3.6%
	www.ascensia.co.uk		35

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