Patent ID: 8741230

Claim:
A fluidic device for detecting the presence or absence of an analyte in a bodily fluid from a subject, comprising a cartridge, said cartridge comprising a sample collection unit and an assay assembly, wherein: (a) said sample collection unit is configured to: (i) collect a sample of bodily fluid from said subject, and (ii) deliver a predetermined portion of said sample to said assay assembly, and wherein said sample collection unit comprises: (1) a sample collection well in fluid communication with a metering channel, configured so that a collected sample flows from said sample collection well into said metering channel; (2) a metering element, wherein said metering element is adapted to close the fluid communication of said sample collection well to said metering channel, thereby isolating a specific volume of said sample in said metering channel, and wherein said metering element comprises a mechanically movable portion configured to be movable from an open position that permits fluid communication between the sample collection well and the metering channel to a closed position that does not provide fluid communication between the sample collection well and the metering channel; and (3) a dilution chamber storing a diluent and being configured to be brought into and out of fluidic communication with said metering channel, said dilution chamber being coupled to the metering channel and defining at least one portion of a pathway for delivering the diluent to said assay assembly; and (b) said assay assembly comprises at least one reaction site containing a reactant that reacts with said analyte to yield a detectable signal indicative of the presence of said analyte.