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CHAPTER
Technical Information 15
39
Glucometer E
SPRIT
Results
Within-run Total
Mean S D C V S D C V
Control mg/dL (mmol/L) mg/dL (mmol/L) (%) mg/dL (mmol/L) (%)
Low 69 (3.83) 2.7 (0.15) 3.9 3.5 (0.19) 5.1
Normal 127 (7.05) 4.7 (0.26) 3.7 5.7 (0.32) 4.5
High 372 (20.64) 5.7 (0.32) 1.5 7.1 (0.34) 1.9
YSI
Glucometer E
SPRIT
Results
Mean Whole
Blood Glucose No. of Mean S D C V
mg/dL (mmol/L) Tests mg/dL (mmol/L) Bias mg/dL (mmol/L) (%)
21 (1.17) 78 19 (1.05) –2 mg/dL or 2.6 (0.14) 13.8
–0.11 mmol/L
49 (2.72) 78 48 (2.66) – 1.8% 3.2 (0.18) 6.7
102 (5.66) 80 103 (5.72) – 0.9% 3.7 (0.21) 3.6
192 (10.65) 79 192 (10.65) – 0.0% 6.4 (0.36) 3.3
376 (20.87) 80 382 (21.20) – 1.6% 10.2 (0.57) 2.7
566 (31.41) 80 593 (32.91) – 4.8% 16.2 (0.90) 2.7
2. Precision:
Precision Results for Whole Blood Specimens: EDTA
anticoagulated glycolyzed whole blood pools were supplemented with
glucose to obtain five glucose levels. Multiple replicates of the whole
blood were tested on one day by multiple operators using multiple
Glucometer E
SPRIT
meters and one lot of sensors. The whole blood
glucose levels of the blood specimens were also tested using the YSI 2300
Stat Plus Glucose Analyzer, a glucose oxidase method. The accuracy of
the YSI was verified using control sera assayed using a modification of the
CDC hexokinase reference procedure (HEW publication no. [CDC] 77-8330).
Precision Results for Controls: The Glucometer E
SPRIT
Control solu-
tions were tested in triplicate twice per day for ten days by one opera-
tor using one meter and one lot of sensors. The following precision
results were obtained:
Glucometer ESPRIT System
(Whole Blood Referenced)
38
CHAPTER
15 Technical Information
Figure 1
Glucometer ESPRIT
System Results
Obtained By 61
Lay Diabetics.
Figure 2
Glucometer ESPRIT
System Results
Obtained By 6
Healthcare
Professionals.
Patient Use Clinical Study Results