Laboratory-Tested Accuracy
Accuracy describes how well the readings from a testing system (meter and test strips) agree with the readings from an accepted reference system (laboratory analyzer), and the coefficient of determination evaluates how much of the variability exists in actual tested values. Independent laboratories have found the EDGE meter to be highly accurate, and an extensive test of 416 data points shows a coefficient of determination of 0.9729.
Laboratory-Tested Precision
Precision describes how consistent readings are from the same test system and the coefficient of variation evaluates the relative closeness of the tested results. Three sets of EDGE test strips were used for within-run and between-run precision studies. Venous blood in heparin tubes was spiked to 4 concentrations. As seen in the following table, the coefficient of variation is less than 5% across all testing, and less than 1.6% above 69.2 mg/dL.
| Precision Study with Venous Blood Samples | ||||
| Number of Samples: | 10 | 10 | 10 | 10 |
| Average (mg/dL): | 20.0 | 69.2 | 101.2 | 154.2 |
| SD (mg/dL): | 1.0 | 1.1 | 1.5 | 2.5 |
| CV (%): | 5.1 | 1.6 | 1.5 | 1.6 |
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