An improved rapid diagnostic device, assay and multifunctional buffer
reagent are provided for the detection of a target analyte in a fluid
test sample. The 2-step assay utilizes a dual component flow-through
device comprising a test unit and a post-filter unit capable of receiving
the fluid sample and multifunctional buffer, respectively. The test unit
comprises a reaction zone containing immobilized capture reagent that can
specifically bind to the target analyte, an absorbent zone supporting the
reaction zone, and optionally, a blood separation zone in lateral fluid
communication with the reaction zone. The post-filter unit comprises a
label zone permeated with a dried indicator reagent which is capable of
being placed in transient fluid communication with the reaction zone of
the test unit during the assay procedure. The rapid diagnostic assay
system reduces the number of assay reagents, method steps and time
required for performance compared to other conventional assays.