Self-contained biological assay apparatus, methods, and applications

摘要

A self-contained, fully automated, biological assay-performing apparatus includes a housing; a dispensing platform including a controllably-movable reagent dispensing system, disposed in the housing; a reagent supply component disposed in the housing; a pneumatic manifold removably disposed in the housing in a space shared by the dispensing platform, removably coupled to a fluidic transport layer and a plurality of reservoirs, wherein the fluidic transport layer, the reservoirs, and a test sample to be introduced therein are disposed in the housing in the space separate from the dispensing platform; a pneumatic supply system removably coupled to the pneumatic manifold in the housing in a space separate from the dispensing platform; and a control system coupled to at least one of the dispensing platform and the pneumatic supply system, disposed in the housing.

主权项

1. An automated process for isolating, amplifying and analyzing a target nucleic acid sequence that may be present in a fluid test sample, comprising:
providing a dispensing system; providing an optical unit comprising a light source and a detector; providing a pneumatic manifold that operates a microfluidic system having at least one amplification/reaction reactor, a fluidic transport layer and at least one fluidic channel disposed in the fluidic transport layer; at least one sample input reservoir, at least one reagent reservoir, and at least one analysis reservoir in fluid connection with the fluidic transport layer; introducing the fluid test sample into the at least one fluidic channel; providing at least one reagent to the at least one fluidic channel from at least one reservoir that is in fluid connection with the fluidic transport layer and the fluidic channel; combining the fluid test sample and the at least one reagent in the fluidic transport layer, the at least one fluidic channel, the at least one sample input reservoir or amplification/reaction reactor; transporting the fluid test sample to the amplification/reaction reactor that is in operative communication with the fluidic transport layer; incubating the fluid test sample in the amplification/reaction reactor under conditions sufficient to permit the target nucleic acid sequence to be amplified in the presence of a fluorescent reporter; illuminating, by the light source, at least a portion of the amplification/reaction reactor; and measuring, by the detector, light emission from the fluorescent reporter in response to illumination by the light source, wherein said measuring is performed in real time during amplification of the target nucleic acid sequence.