Patent ID: 7267992

Claim:
A method for the determination of the presence of an analyte in a sample, the method comprising the steps of: providing an element comprising a sample application zone, a detection zone located downstream from the sample application zone and being the last zone of the element that allows liquid transport, the detection zone being devoid of a binding reagent that would enable detection of the analyte, a zone containing immobilized analyte or analyte analogue located between the sample application zone and the detection zone, a conjugate impregnated in a matrix material located upstream of the zone containing immobilized analyte or analyte analogue, the conjugate can be detached from the matrix material by liquid and comprises a first bioaffine binding partner capable of a specific binding reaction with the analyte to be determined and a first detectable label, wherein the first detectable label is a low molecular organic molecule, and a universal conjugate, located upstream of the zone containing immobilized analyte or analyte analogue, which can be detached by liquid and comprises a second bioaffine binding partner and a visually detectable label, the second bioaffine binding partner is capable of a specific binding reaction with the first detectable label, wherein the visually detectable label is a direct visually detectable label formed to carry out the determination of the analyte in the detection zone, wherein the matrix and the zones are made form liquid permeable transport materials, contacting the sample application zone of the element with the sample, allowing the sample and any analyte present therein to migrate from the sample application zone to contact and react analyte present in the sample with the conjugate impregnated in the matrix material and the universal conjugate to form a detection complex, determining the presence of the detection complex in the detection zone of the element, and relating the presence of the complex in the detection zone with the presence of the analyte in the sample.