An assay device for the detection of analyte in a sample, methods and
immunoassay formats for performing an assay with or without the device,
and methods for manufacturing the device are provided. The device is a
continuous liquid flow channel having a proximal and a distal end, with a
detection membrane in fluid communication with the distal end of the flow
channel. Interspersed between the assay buffer and detection membrane, and
continuous with the liquid flow channel, are a sample delivery means, one
or more reservoirs containing the reagents necessary for conducting the
assay, and, optionally, mixing or incubation reservoirs for combining the
sample and reagents. The geometry of the liquid flow channel regulates the
flow rate of the liquids through the channel, thereby controlling
incubation, mixing and reaction time. The preferred detection membrane is
an immunochromatographic test strip containing immobilized reagents. The
detection of labeled reagent in a particular area of the detection
membrane reflects the presence or relative amount of analyte in the
sample. Detection may be achieved visually. One or more liquid flow
channels may be contained within a single housing for simultaneous,
consecutive, or comparative sample analysis.