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). Independent laboratories in Hamburg, Germany and Postfach, Switzerland have found the UASure meter to be highly accurate, and results from both laboratories compared well with results from the EPAC 6140 tester. Capillary and venous blood comparison studies between the UASure system and Hitachi/Roche system yield the following linear regression data:
| Clinical Site Studies with Capillary Blood Samples | |
| Number of Samples: | 450 |
| Range: | 2.6 mg/dL to 14.5 mg/dL |
| Slope: | 0.949 |
| Intercept: | 0.246 mg/dL |
| Correlation Coefficient: | 0.969 |
| Clinical Site Studies with Venous Blood Samples | |
| Number of Samples: | 480 |
| Range: | 2.6 mg/dL to 20.2 mg/dL |
| Slope: | 0.953 |
| Intercept: | 0.125 mg/dL |
| Correlation Coefficient: | 0.984 |
Laboratory-Tested Precision
Precision describes how consistent readings are from the same test system. Three lots of UASure test strips were used for within-run and between-run precision studies. Venous blood in heparin tubes was spiked to 4 concentrations. Blood uric acid readings were recorded for 10 days, resulting in 100 data points for each concentration. Data were averaged with three lots of test strips as shown in the following table:
| Precision Study with Venous Blood Samples | ||||
| Number of Samples: | 100 | 100 | 100 | 100 |
| Average (mg/dL): | 5.7 | 9.0 | 11.9 | 15.0 |
| SD (mg/dL): | 0.26 | 0.37 | 0.45 | 0.44 |
| CV (%): | 4.5 | 4.2 | 3.8 | 2.9 |