| 摘要 |
The novel analytical devices and methods of the present invention involve dual pathway devices which provide for the confirmation of sandwich or competitive assay results. In a self-confirming sandwich assay, the labeled analyte complex becomes immobilized within a first pathway at an assay capture site to indicate the presence or amount of an analyte in the test sample. In a second pathway, a confirmatory reagent blocks the binding of the analyte or labeled analyte complex to a confirming assay site, thereby confirming that the presence of label in the assay capture site indicates a positive test sample. In a self-confirming competitive assay, a confirmed positive result is one in which the device displays a decrease in signal or no signal at the assay capture site, and the confirming assay site displays a detectable signal. |
