The accuracy of the EtG Rapid Test Device was evaluated in comparison to a commercially avaialbe EIA Test. Five Hundred (500) clinical samples were tested. All positive samples were confirmed by Liquid Chromatography/Mass Spectrometry.
The reproducibility of the EtG Rapid Test Device (Urine) was verified by blind tests performed at four different locations. Samples with EtG concentrations at 50% of the cut-off were all determined to be negative, while samples with EtG concentrations at 200% of the cut-off were all determined to be positive.
Test precision was determined by blind tests with control solutions. Controls with EtG concentrations at 50% of the cut-off yielded negative results, and controls with EtG concentrations at 150% of the cut-off yielded positive results.
The following compounds yielded negative results up to a concentration of 100 μg/mL: