| 主权项 |
1. An assay device to determine the presence of at least one analyte of interest in a liquid sample, the device comprising a test strip on which is deposited:
a first directly-labeled analyte-specific binding reagent for generating a first signal, or “test” signal; and a second directly-labeled specific binding reagent from a control suspension for generating a second signal, the generation of which second signal indicates both
a) the test has been successfully conducted, and thatb) sufficient time has elapsed following contact of the assay device with the liquid sample for the test to be read and for the first signal to have been properly generated,said second directly-labeled specific binding reagent binds to the control, not the analyte, and said second signal being used both as a control means and an end of assay timer, wherein the presence of the second signal, but not the first signal, indicates that the analyte is not present; wherein the device comprises a depot of labeled, analyte-specific binding reagent and, downstream thereof, a depot of labelled, control specific binding reagent. |
